Philips Respironics Ventilator User manual

BiPAP® Focus™ Ventilator

SERVICE MANUAL

REF 1029568 Rev A

This work is protected under Title 17 of the United States copyright code and is the sole property of Respironics. No part of this document may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specifically permitted under United States copyright law, without the prior written consent of Respironics.

In the U.S. and Canada

Respironics California, Inc. 2271 Cosmos Court Carlsbad, CA 92011 USA 1-800-345-6443

For Technical support, contact:

Respironics, Inc. Customer Service Within the U.S.A. 1-800-345-6443 Outside the U.S.A. 724-387-4000 Facsimile 724-387-5012 service@respironics.com

II BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

1. Introduction and Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Recommended Tools and Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Where to Go for Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

2. Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

3. Theory of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Settings: CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Settings: S/T Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Measured Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Nurse Call Station/Serial Communications Connector Pinout . . . . . . . . . . . . 3-10

Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Triggers and Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Bacteria Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Date of Manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Pneumatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

4. Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Storing the BiPAP Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Cleaning the Reusable Air Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Replacing the Air Inlet Filter(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

5. Diagnostic Mode and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 5-1

Entering Diagnostic Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Product Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Preferences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Significant Event Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Setting Up the Serial Interface for DRPT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. III

Table of Contents

6. Ventilator Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

7. Performance Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Generating a Diagnostic Report (DRPT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Sensor Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

System Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Significant Event Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Download Service Software to the Service PC . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Installing Communications Software on the Service PC . . . . . . . . . . . . . . . . . . . . 6-2

Starting the BiPAP Focus Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Downloading Controller Board Software to the Ventilator . . . . . . . . . . . . . . . . . . . 6-4

Downloading UI Software to the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Reprogramming the BiPAP Focus Serial Number . . . . . . . . . . . . . . . . . . . . . . . 6-13

Required Test Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Preliminary Cleaning, Inspection, and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Electrical Safety Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Alarm/LED Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

BiPAP Focus System Run-in. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Real-time Clock Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

If Real-Time Clock Calibration Fails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

MFTS Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Multi Function Test Station Set-up (MFTS) . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

MFTS software setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Unit Under Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Field Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

Recording Serial Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Performance Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28

Performance Verification Data Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29

8. Component Removal/Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Disconnecting Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Top Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

VGA Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

User Interface Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

Controller PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

Blower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

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Table of Contents

Secondary Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

Primary Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16

Main Body Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16

Interconnect Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17

9. BiPAP Focus Replacement Parts List . . . . . . . . . . . . . . . . . . . . . . . 9-1

Complete Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Exterior. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Exterior

(continued) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Front Panel/User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Ventilator Interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Communications Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Electronic Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. V

Table of Contents

VI BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Chapter 1. Introduction and Intended Use

The BiPAP Focus Non-invasive Ventilator is a microprocessor-controlled, electrically powered mechanical ventilator. The BiPAP® Focus™ Ventilator System provides noninvasive ventilation for adult (over 30 kg or 66 lbs.) patients for the treatment of respiratory insufficiency and distress, and obstructive sleep apnea. The BiPAP Focus is appropriate for acute, sub-acute, and intra-hospital transport settings.

The BiPAP Focus System is intended for use with nasal and full face masks. The BiPAP Focus is not intended to be a life-support device.

The BiPAP Focus Ventilator meets or exceeds all applicable safety requirements, consensus guidelines, US regulatory statutes, and international regulatory standards for life support/mechanical ventilation devices.

Read this manual thoroughly prior to performing service or maintenance on the BiPAP Focus Ventilator. This manual contains advanced troubleshooting, calibration, and maintenance instructions for the BiPAP Focus. All maintenance and repair work should be performed by qualified biomedical technicians who have received appropriate training and authorization to provide maintenance, repair, and service for the BiPAP Focus.

Review the operating instructions for the BiPAP Focus Ventilator before running tests, checking operational readiness, or initiating patient use. These instructions include important information about ventilator safety and operation.

For additional information about accessories or related equipment, such as humidifiers and remote alarm systems, refer to the appropriate instruction manual prior to operating with the BiPAP Focus Ventilator.

The BiPAP Focus Operator’s Manual for the BiPAP Focus Ventilator lists all applicable warnings and cautions. Review these notices thoroughly before operating the ventilator.

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 1-1

Chapter 1

Introduction and Intended Use

Recommended Tools

and Test Equipment

Table 1-1 lists the recommended tools, test equipment, and materials required to service and maintain the BiPAP Focus Ventilator.

Description Manufacturer and Model

Test Equipment

Digital multimeter (DMM) accurate to three decimal places

Electrical safety analyzer Dale LT 5440 or equivalent

Pneumatic calibration analyzer capable of measuring low pressure (cmH (liters)

O), flow rate (LPM), and volume

Ventilator Accessories

Connector, plastic, 22mm OD Respironics P/N 1006242 or equivalent

Connector, 22-mm (quantity 2) Respironics P/N or equivalent

Flow Control Valve Respironics P/N 1006120

Pressure test adapter Respironics P/N 312710

Tee, plastic with silicone rubber coupling Respironics P/N C06260 or equivalent

Tee silicone (quantity 2) Respironics P/N 1006243 or equivalent

Hand Tools and Materials

Pliers Local supplier

#1 Phillips head screwdriver Local supplier

#2 flat head screwdriver Local supplier

#2 Phillips head screwdriver Local supplier

Cleaning Cloth Local supplier

Isopropyl Alcohol Local supplier

Metric hex key set (rounded ends), 1.5 to 4 mm Local supplier

Mild detergent or antiseptic wipes Local supplier

Needle nose pliers Local supplier

BiPAP Focus Communications Cable Kit (USB & DB9)

PC or laptop (required for downloading software) Required: Windows XP operating

Pen size flat head screwdriver Local supplier

Pen size Phillips head screwdriver Local supplier

Test lung, hard sided Respironics P/N 1021671 or local

Torque driver capable of 1 to 25 in.-lbs (N-m) Local supplier

Local Supplier

Respironics P/N 1012598 or equivalent

Respironics P/N 1030010

systems, serial comm port, and USB port

supplier

Table 1-1: Recommended Test Equipment, Tools, and Materials

1-2 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Introduction and Intended Use

Where to Go for Help For Customer Service and Product Support contact:

Respironics, Inc. USA telephone: 1-800-345-6443 USA: 1-800-886-0245 International telephone: 724-387-4000 International fax: 724-387-5012 service@respironics.com. clinical@respironics.com. www.respironics.com.

Chapter 1

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 1-3

Chapter 1

Introduction and Intended Use

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1-4 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Chapter 2. Warnings and Cautions

Warnings, Cautions, and Notes are used throughout this manual to identify possible safety hazards, conditions that may result in equipment or property damage, and important information that must be considered when performing service and testing procedures on the BiPAP Focus.

WARNING: A condition that could cause injury to a patient, operator or technician if

the operating instructions in this manual are not followed correctly.

CAUTION: A condition that could cause damage to, or shorten the service life of,

the device.

NOTE: Important information concerning the construction or operation of the

device.

Warnings • To assure the safety of the service technician and the specified

performance of the device, Respironics recommends that only technicians having prior training or experience servicing ventilatory devices perform any repairs or adjustment to the BiPAP Focus.

• Use only Respironics repair/service parts. Use of non-Respironics parts may alter ventilator reliability resulting in damage. Use of non-Respironics repair parts will affect the ventilator warranty. Contact Customer Service at 1-800-345-6443 or 724-387-4000 for more information.

• High voltages are present in the AC/DC Power Supply, Power Cord and VGA PCB. To avoid electrical shock, disconnect the power cord before attempting any repairs on the device or cleaning.

• DO NOT immerse this device into any fluids or allow any liquid to enter the cabinet or the filter intake.

• To avoid personal injury, always disconnect external AC and DC power sources from the ventilator before servicing or cleaning.

• To avoid personal injury or the possibility of damage to the ventilator, regularly inspect the power cord to ensure it is free from defects and any obvious wear and is properly grounded.

• This device is not for life support.

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 2-1

Chapter 2

Warnings and Cautions

• Never troubleshoot while a patient is connected to the ventilator, since normal operation is suspended.

• If the ventilator has been operating, the internal parts may be hot. Use caution when accessing.

• To prevent disease transmission, use protective equipment when handling contaminated bacteria filters or other patient accessories. Follow manufacturers' labeling and institutional guidelines for disposal of contaminated accessories.

• To avoid cross-contamination between the test equipment and ventilator, always install a bacteria filter between the main outlet and test device.

• Explosion hazard. Do not operate the ventilator in the presence of flammable anesthetic agents.

• To avoid the risk of fire, use only Respironics-approved batteries. All battery connections are keyed to ensure proper connection. Do not attempt to connect a battery incorrectly. Only qualified technicians should install the battery.

• Use only Respironics-supplied cables with the nurse call station/ serial communications connector.

• To avoid personal injury or the possibility of damage to the ventilator, DO NOT operate this device if it has failed any of its diagnostic tests, either self or service initiated.

Cautions • Federal law (US) restricts this device to sale by, or on the order of,

a physician.

• Failure to replace a dirty filter may cause the device to operate at higher than normal temperatures and damage the device.

• Use only Respironics-approved filters.

• Use only Respironics-approved batteries.

• The gray reusable air inlet filter must be completely dry before use. Never place a wet filter into the device.

• Do not place more than one gray reusable air inlet filters that come with the ventilator into the device at the same time. One gray reusable air inlet filter and one white disposable ultra-fine filter may be used.

• Replace any filter that is damaged.

• Do not attempt to clean or reuse disposable air inlet filters.

• Electronic components used in this device are subject to damage from static electricity. Repairs made to this device must be performed only in an antistatic, Electro-static Discharge (ESD)protected environment.

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Chapter 2

Warnings and Cautions

• Care should be taken to avoid exposure of the BiPAP Focus to

temperatures at or near the extremes of those specified in Chapter

3. If exposure to such temperatures has occurred, the device should be allowed to return to room temperature before being turned on.

• Never place liquids on or near the BiPAP Focus.

• The information in this manual is provided for service personnel

reference.

• Always ensure that you are following proper electrostatic discharge

(ESD) grounding procedures before handling static-sensitive devices.

• Be careful not to pull or crimp any cables, tubes or wires.

• Troubleshooting and repair should be performed only by a

qualified service technician.

Notes • Refer to the BiPAP Focus Operator’s Manual for product use,

additional Warnings, Cautions and Notes.

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Chapter 2

Warnings and Cautions

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2-4 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Chapter 3. Theory of Operation

The BiPAP® Focus™ Ventilator System provides noninvasive breathing support for adult patients weighing 30 kg (66 lbs.) or greater.

The BiPAP Focus System offers two ventilation modes:

• Continuous positive airway pressure (CPAP), which provides a single level of positive pressure to the patient.

• Spontaneous/Timed (S/T), which provides two levels of positive pressure (one during inspiration and one during exhalation), and delivers timed breaths if the patient does not initiate a breath.

The BiPAP Focus System alarms annunciate when high or low pressure regulation, apnea, patient disconnect, low power, or loss of mains power conditions occur. The system displays a real-time estimated delivered pressure bar graph.

An Apnea Rate (#Apnea) Alarm is provided to alert the caregiver to repeated periods of short apneas of 10 seconds or more. The caregiver can set the value for how many apnea periods (10 seconds or more) can occur within an hour before alarming. The total number of Apnea periods (10 seconds or more) for the previous hour is displayed as part of the patient data. Because the previous hours data is displayed, the number of apnea periods for the first hour is an estimate only.

The BiPAP Focus System includes alarm silence and alarm pre-silence features. Battery backup provides a minimum of 45 minutes of backup power at default settings in case AC power is not available (for example, during transport within the hospital).

The BiPAP Focus System features Digital Auto-Trak™, which allows it to recognize and compensate for unintentional leaks and promote synchrony by adjusting its trigger and cycle algorithms to maintain optimum performance.

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 3-1

Chapter 3

Theory of Operation

Air Delivery System Components

Air Inlet Filter(s) The air inlet filter removes coarse particulate from

Blower The blower draws room air though the air inlet filter and

ambient air as it is entrained into the blower assembly. See Section 4 for periodic maintenance information. The BiPAP Focus has a reusable dust filter that is gray in color. An optional pollen filter, white in color is also available.

muffler, and outputs air for delivery to the patient. The DC impeller-type blower recirculates air through the flow valve when not delivering gas to the patient. Compressor speed is determined by patient settings. The controller PCB controls compressor speed.

Table 3-1: Air Delivery System Components

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Chapter 3

Theory of Operation

Air Delivery System Components (Continued)

Flow valve (FV) The flow valve (valve assembly) is a mechanical sliding

assembly driven by an electromagnetic coil. Valve commands from the PCB control current (-125mA to 675mA) to the coil. Movement of the flow valve is proportional to the current through the coil. The flow valve operates as a closed-loop system, using feedback from the flow sensor and pressure transducers.

Air Flow Sensor The air flow sensor measures flow from the flow valve.

The ventilator uses this measurement to provide closed loop control of the flow valve and to compute the flow and volume delivered to the patient.

Table 3-1: Air Delivery System Components

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 3-3

Chapter 3

Theory of Operation

Electronic System Components

User Interface PCB • Motorola 68332 microcontroller

• Inter-processor communication with controller PCB

• VGA Display, Keyboard and front panel LED Interface

• Primary alarm driver

• Remote alarm relay

• USB and RS-232 serial communication

• Internal Battery charging and monitoring

• Temperature monitor

• Microcontroller watchdog and reset logic

• Voltage monitoring

Controller PCB • Blower On / Off / Closed-Loop Speed Control

• Air Flow Valve Controller

• Pressure Measurement

• RS-232 Communication

• Inter-processor communication with interface PCB

• Backup alarm driver

VGA PCB • STN Blue Mode Transmissive Viewing

• One-Quarter VGA (320 x 240)

• Dot Pitch 0.36mm x 0.36mm

Table 3-2: Electronic System Components

3-4 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Theory of Operation

Electronic System Components (Continued)

External AC/DC Power Supply • 90-240 VAC, 40-60Hz Input

• 120 Watt 18 Volt DC Output

Chapter 3

Internal NiMH (Nickel Metal Hydride) Battery

Table 3-2: Electronic System Components

• 8 cell 3.8 Amp Hour provides 9.6 Volt output nominal

• In-line thermal fuse

• Built-in thermistor for temperature monitoring

• Nominal charge time under 5 hours

• Nominal run time 45 minutes

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 3-5

Chapter 3

Theory of Operation

Back Panel The back panel has three connection points and the On/Off switch.

• Nurse call station / serial communications port

•USB port

• AC/DC Power supply input & power cord relief clip

•ON/OFF switch

USB port

AC/DC power supply input

ON/OFF switch

Shown in the OFF position

Nurse call station/serial communications port

Specifications Default Settings

S/T mode RR = 4/min

IPAP = 12 cmH

EPAP = 4 cmH

Rise-Time = 2 Ramp Start = 4 cmH

Settings: CPAP Mode

CPAP

Continuous Positive Airway Pressure

Power cord relief clip

Figure 3-1: Back Panel

O I-Time = 1 sec

O Ramp Time = 0 min

Range: 4-20 cmH

Resolution: 1 cmH

Dynamic accuracy: ±5 cmH

O (4-20 hPa)

O (1 hPa)

O (5 hPa)

Ramp Time

Period over which the ventilator increases inspiratory pressure from Ramp Start setting to CPAP setting.

Range: 0-45 min.

Resolution: 5 min.

Accuracy: ±10% of setting

3-6 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Chapter 3

Theory of Operation

Ramp Start

Initial inspiratory pressure

Settings: S/T Mode

IPAP

Inspiratory positive airway pressure, the inspiration pressure setting

EPAP

Expiratory positive airway pressure, the exhalation pressure setting

Rise-Time

How quickly the ventilator increases inspiratory pressure from EPAP pressure to 67% of pressure support level

Range: 4 cmH2O to CPAP setting (4 hPa to CPAP setting)

Resolution: 1 cmH2O (1 hPa)

Range: 4-30 cmH

Resolution: 1 cmH

O (4-30 hPa)

O (1 hPa)

Dynamic accuracy: ±5 cmH2O (5 hPa)

IPAP cannot be set below EPAP.

Range: 4-25 cmH

O (4-25 hPa)

Resolution: 1 cmH2O (1 hPa)

Dynamic accuracy: ±5 cmH

O (5 hPa)

Range: 1-6 (where 1 = 0.1 sec and 6 = 0.6 sec)

Resolution: 1

Accuracy: ± (0.15 + 10% of setting) sec

Rate

Respiratory rate, used to determine if a timed breath is delivered

Range: 1-30/min

Resolution: 1/min

Accuracy: ±1/min or ±10% of setting, whichever is greater over a 4-minute period.

I-Time and Rate settings cannot allow I-Time to exceed expiratory time.

I-Time

Inspiratory time

Range: 0.5-3 sec

Resolution: 0.1 sec

Accuracy: ± (0.1 + 10% of setting) sec

I-Time and Rate settings cannot allow I-Time to exceed expiratory time.

Ramp Time Range: 0-45 min

Resolution: 5 min

Accuracy: ±10% of setting

Ramp Start

Initial inspiratory pressure

Range: 4 cmH

Resolution: 1 cmH

O to EPAP (4 hPa to EPAP)

O (1 hPa)

REF 1029568 Rev A BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. 3-7

Chapter 3

Theory of Operation

Measured Data

Patient circuit pressure bar graph (continuous display)

Rate

Measured respiratory rate

Est. Vt

Estimated delivered tidal volume

Est. MV

Estimated exhaled minute volume

Range: 0-35 cmH2O (0-35 hPa)

Resolution: 1 cmH

Accuracy: ±10% of scale

In the event of total loss of power, the inspiratory and expiratory pressure measured at the patient exhalation port at 60 L/min is less than 1 cmH2O

by virtue of mask and ventilator design.

Range: 0-60/min

Resolution: 1/min

Accuracy: ± (1 + 10% reading)

Range: 0-4000 mL

Resolution: 1 mL

Accuracy (S/T Mode): ± (50 mL + 10% reading) (when leak <60 L/min, using the Vision circuit)

Accuracy (CPAP Mode): ± (100 mL + 10% reading) (when leak <60 L/min, using the Vision circuit)

Vt display flashes when peak inspiratory flow for successive breaths varies by more than 15 L/ min.

Range: 0-99 L/min

Resolution: 0.1 L/min

Accuracy: ± 1 L or ± 10% actual, whichever is greater (when leak is <60 L/min using the Vision circuit).

O (1hPa)

Leak

Estimated Patient leak

#Apnea

Brief apnea periods

Trigger

Breath trigger

NOTE: Est. Vt and Est. MV estimates are at ambient temperature and pressure, dry (ATPD). Pressure signals are filtered using a 50-Hz low pass Butterworth filter.

Range: 0-150 L/min

Resolution: 1 L/min

Accuracy: ± (15 L/min +10%)

Range: 0-99/hour

Resolution: 1/hour

Accuracy: ± 1/hour (after 1 hour)

Range: Patient or Timed (ventilator)

3-8 BiPAP® Focus™ Ventilator Service Manual © Respironics, Inc. REF 1029568 Rev A

Alarm Settings

Chapter 3

Theory of Operation

Apnea

The length of time without a spontaneous breath that triggers the Apnea alarm

#Apnea

The number of periods (10-seconds or more) in the previous hour where the patient has not initiated a spontaneous breath.

NOTE: For the first hour, this value is an estimate only.

Options

Display Units

Unit of pressure: centimeters of water (cmH

O), hectoPascals (hPa), or

millibars (mbar).

Alarm Volume

Audible alarm volume

Range: 20, 40, 60 sec or OFF

Default setting: 20 sec

Range: 5, 10, 20, or OFF

Default setting: OFF

Range: cmH

Range: OFF, or minimum volume, to maximum volume, in 5 discrete settings.

O, hPa, or mbar

Contrast

Screen contrast

Brightness

Screen brightness

Reverse Video

Toggles reverse video

Screen Lock Timer Range: ON or OFF

Range: 20% to 100%

Range: 10% to 100%

Range: ON or OFF

Chapter 3

Theory of Operation

Nurse Call Station/Serial Communications Connector Pinout

Pin Signal

Nurse Call Station

1 Nurse call station common

6 Normally open (NO) during normal (non-alarm) operation

9 Normally closed (NC) during normal (non-alarm) operation

Serial Communications

2 Respironics advanced serial protocol (RASP) RS-232 Transmit (Tx)

3 RASP RS-232 Receive (Rx)

4 Not used

5 RS-232 signal ground

7 RS-232 Tx (reserved for future use)

8 RS-232 Rx (reserved for future use)

NOTE:

• When pins 1 and 6 are used, the relay is open during normal operation, and closed during an alarm condition including loss of power.

• When pins 1 and 9 are used, the relay is closed during normal operation, and open during an alarm condition including loss of power.

• Female DB9 connector pin configuration:

WARNING: Use only Respironics-supplied cables with the nurse call station/serial

communications connector.

Physical

BiPAP Focus System Dimensions

355-mm H x 290-mm W x 140-mm D (14.0-in. H x 11.4-in. W x 5.5-in. D)

Excluding accessories, gas inlets, patient connections.

Weight 4.5 kg (10 lbs.)

Chapter 3

Theory of Operation

Power

Input range 90-264 V~, 47-63 Hz, 90 VA

Battery backup 3.8 amp-hour (Ah) nickel metal hydride (NiMH) battery

provides 45 minutes of operation at default settings. System automatically activates the battery charge cycle when connected to AC power and the ON/OFF switch is ON ( | ) (during normal operation or Standby mode).

Recharge time is typically under 5 hours, but may extend further depending on machine settings if operating on battery prior to recharge, or if operating in elevated ambient temperature (above 28°C). Charge is complete when the green CHARGING LED extinguishes.

Nurse call station relay Rated current: 0.280 A

Rated voltage: 250V

Fuse type No replaceable fuses.

Power cord Refer to the“Complete Parts List” on page 9-1

Triggers and Cycles

Volume-based trigger

Flow reversal cycle

Shape signal

Timed trigger

IPAP maximum of 3.0 seconds

Peak flow cycle

Supplemental Oxygen

Flow and pressure into oxygen valve

Maximum flow: 15 L/min at ambient pressure

Environmental

Temperature Operating: +5 to +35°C at 10 to 95% relative

humidity

Storage: -20 to 60°C at 95% relative humidity

Atmospheric pressure Operating: 83 to 102 kPa (830 to 1020 mBar)

Chapter 3

Theory of Operation

Storage When the BiPAP Focus is not in use for periods

of 2 weeks or longer, it is recommended that the unit be stored in a clean, sanitized plastic bag.

Bacteria Filter

Dead space 68 mL

Bacteria/viral filter efficiency

Resistance 0.7 cmH

Connectors Male connector 15-mm I.D./22-mm O.D.

>99.99% P/N 342077

O/L/s at 0.5 L/s

Female connector 22-mm I.D.

Date of Manufacture

The 12-digit serial number located on the base of the unit indicates the date of manufacture. From left to right, the fifth and sixth digits indicate the year; the seventh and eighth, the month; the ninth and tenth, the day. For example, the serial number 0001050903-20 indicates that the device was manufactured 3 September, 2005.

Pneumatics BiPAP Focus System pneumatic diagram:

Chapter 3

Theory of Operation

Air inlet port

BiPAP Focus System

Air inlet filter

Muffler

Blower

(motor)

Pressure sensor

Flow sensor

Control valve

Tubing (elbow)

Diffuser

Bacteria filter (mandatory)

Patient circuit (to mask outlet)

Oxygen adapter (if using oxygen)

Oxygen valve (if using oxygen)

Outlet port and pressure sensor

Chapter 3

Theory of Operation

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Chapter 4. Periodic Maintenance

This chapter provides guidelines and illustrates the cleaning and maintenance procedures for the BiPAP Focus system.

Table summarizes maintenance procedures for the BiPAP Focus System.

To ensure correct operation, perform all maintenance at the recommended intervals.

BiPAP Focus System Maintenance

Part Interval Procedure

Battery Replace the battery if a

Batt. Charge Failure alarm occurs, or as indicated in See “Replacing the Battery” on page 4-3.

Air inlet filter(s) Reusable: clean monthly

or as needed.

Reusable: every year or as needed.

Disposable: replace as needed.

The air path cannot be cleaned.

System exterior As needed. Clean the exterior of the ventilator with

Qualified service technician only.

NOTE: If the unit has been in storage or has not been used for 3 months, the battery will require a full charge.

Follow the “Cleaning the Reusable Air Inlet Filter” on page 4-2.

Replace.

Do not attempt to clean or reuse disposable filters.

a soft damp cloth moistened with any of the following solutions:

• Mild detergent or soapy water

• 10% bleach solution (90% water)

• Isopropyl alcohol (91%)

• Quaternary ammonium germicides (sprays or disposable cloths)

Do not spray or immerse in liquid. Do not allow liquid to penetrate the system.

Flow Valve Assembly

10,000 hours (Total operating hours Refer to Figure 5-3 on page 5-3.)

Replace Flow Valve Assembly

Table 4-1: BiPAP Focus System Maintenance

Chapter 4

Periodic Maintenance

Storing the BiPAP

Focus

Cleaning the

Reusable Air Inlet

Filter

When the BiPAP Focus is not in use for periods of 2 weeks or longer, it is recommended that the unit be stored in a clean, sanitized plastic bag.

While the unit is being stored, ensure that the power switch on the back of the unit is in the OFF (O) position. If the switch is not turned OFF, the internal battery will be depleted within two weeks. If the unit is stored with the power switch in the OFF (O) position, the internal battery will deplete within 3 months.

Follow these steps to clean the reusable air inlet filter (Figure 1):

1. Remove the filter via the main rear access door (filter door) and examine for damage or debris on the filter.

2. Wash using one of the following solutions, then rinse thoroughly:

• Liquid dishwashing detergent

• White distilled vinegar (5% acidicy)

• Isopropyl alcohol (99.9%)

• Hydrogen peroxide (3%)

• Bleach

• Sodium hypochloride (6%)

3. Allow the filter to dry completely before reinstalling.

Figure 1: Reusable Air Filter

Reusable air inlet filter

(gray)

CAUTION: Failure to replace a dirty filter may cause the device to operate at higher

than normal temperatures and damage the device.

CAUTION: Use only Respironics-approved filters.

CAUTION: The gray reusable air inlet filter must be completely dry before use. Never

place a wet filter into the device.

Filter door

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