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BiPAP Focus Ventilator S E R V I C E M A N U A L...
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ALL RIGHTS RESERVED. 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.
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Installing Operating Software on the Ventilator ....6-12 Reprogramming the BiPAP Focus Serial Number....6-22 7 Testing, Calibration, and Performance Verification .
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8.11 Interconnect Diagrams ........8-18 9 BiPAP Focus Replacement Parts List ......9-1 Complete Parts List .
The BiPAP Focus is appropriate for acute, sub-acute, and intra-hospital transport settings. The BiPAP Focus is intended for use with nasal and full face masks, and is not intended to be a life-support device.
• To avoid injury to the patient airway, DO NOT use the BiPAP Focus where ambient room temperature is above 95 °F (35 °C) because outlet gas temperature may exceed 106° F (41°C).
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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 connectors are keyed to ensure proper connection. Do not attempt to connect a battery incorrectly.
If a 343 error code is displayed, remove the battery and charge it using the BiPAP Focus battery charging cable (P/N 1040421). This cable provides the initial charge required so that the ventilator can recharge a depleted battery. Refer to the battery charge instructions supplied with the cable.
Chapter 2 Warnings and Cautions 2.3 Notes • Refer to the BiPAP Focus Operator’s Manual for product use, additional warnings, cautions, and notes. • Service calibration procedures require a printer to be assigned to the service PC: this can be an internal print location (for example, using Adobe PDF) or a printer connected to the PC.
AC power conditions occur. The system displays a real- time estimated delivered pressure bar graph. The BiPAP Focus includes alarm silence and alarm pre-silence features. A fully charged backup battery 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).
Chapter 3 Theory of Operation 3.2 Electronic System The BiPAP Focus electronic system controls, monitors, and displays patient and ventilator data. Two microcontrollers (on the user interface and controller PCBs) interpret user and sensor inputs while controlling inspiratory and expiratory pressures according to the selected ventilator settings. Figure 3-2 shows an interconnect block diagram of the BiPAP Focus ventilator.
Chapter 4 Periodic Maintenance 4.4 Battery WARNING: To avoid the risk of fire, use only Respironics-approved batteries. All battery connectors are keyed to ensure proper connection. Do not attempt to connect Maintenance a battery incorrectly. NOTE: Recharge the battery if a Low Battery or Battery Depleted alarm occurs during a pre-operational check.
Because reconnecting the charged battery is time-sensitive, read these instructions before beginning this procedure. BiPAP Focus charging circuitry is designed to detect a battery with a minimum voltage of 2.80 VDC as measured across the red and black battery connector wires.
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Figure 4-6: Charging the Battery 5. Allow the two to remain connected for a minimum of 15 minutes. 6. Disconnect the battery charging cable and reinstall the BiPAP Focus battery within 30 seconds. 7. Connect the ventilator AC power cord to wall power and turn the ON/ OFF switch ON (I).
3. Launch the HyperTerminal program on the PC by clicking Start > Programs > Accessories > Communications > HyperTerminal. 4. Enter a name for the connection (Figure 5-8 shows BiPAP Focus), choose an icon, then click OK. REF 1029568 Rev B...
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Chapter 5 Diagnostic Mode and Troubleshooting Figure 5-8: Entering a Name for the Connection to the BiPAP Focus Ventilator 5. Select the appropriate serial port from the Connect using: drop-down list (Figure 5-9 shows COM1), then click OK. Figure 5-9: Selecting the Serial Port 6.
Chapter 5 Diagnostic Mode and Troubleshooting 5.8 Generating a 1. With the BiPAP Focus ventilator in Diagnostic mode and the Diagnostics end of the serial communications cable connected to the Diagnostic Report ventilator, start HyperTerminal, open the BiPAP Focus (DRPT) Communications file, or click on the BiPAP Focus Communications icon on the PC (if created).
903 - Ext Wdog Unexpected and 310 POST Abnormal Reset.) Off = No change. 5.10 Significant The BiPAP Focus Ventilator generates a log of system events that can be used for troubleshooting, including settings changes, alarms, and codes. If a Event Codes...
Chapter 6. Ventilator Communications This chapter describes how to install operating software onto the BiPAP Focus ventilator. 1. Connect the service PC to the ventilator and enter ventilator Download mode (section 6.1). 2. Install USB driver software onto the service PC (section 6.2).
NOTE: Do not connect or use the BiPAP Focus USB cable while connected to a docking station. Do not connect the BiPAP Focus USB cable through a USB hub. Using docking stations or USB hubs causes communication errors.
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Chapter 6 Ventilator Communications 2. Connect the USB cable (from BiPAP Focus communications cable kit P/N 1039800): insert the Type B end into the ventilator USB port, and the Type A end to the service PC (Figure 6-2). USB Type B end...
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Chapter 6 Ventilator Communications 11. If prompted to insert the Respironics CD (already in the drive), click OK (Figure 6-13). Figure 6-13: Insert Disk Window 12. At the Files Needed window, click Browse and select the CD-ROM drive (Figure 6-14).
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(Figure 6-28). Figure 6-28: Phase 1 Complete, Start Phase 2 7. The Phase 2 BiPAP Focus Wizard opens to begin installing software on the user interface PCB. The ventilator should still be in Download mode and the cables connected. Click Next and follow the screen prompts (Figure 6-29).
Chapter 6 Ventilator Communications 6.4 Reprogramming The serial number of each BiPAP Focus Ventilator is stored in non-volatile memory on the user interface PCB, and must be reprogrammed if you replace the BiPAP Focus the PCB. Serial Number 1. Write down the serial number from the bottom of the unit, include hyphens if the serial number includes them.
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Chapter 6 Ventilator Communications 5. When the BiPAP Focus wizard asks what operation to perform (Figure 6-41), select I want to perform advanced configuration operations, then click Next. Figure 6-41: Selecting Advanced Configuration Operations 6. Select I want to modify the BiPAP Focus ventilator’s configuration, then click Next (Figure 6-42).
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Chapter 6 Ventilator Communications 9. At the BiPAP Focus Wizard Phase 2 Completion window appears, click Finish (Figure 6-45). Figure 6-45: Phase 2 Wizard Complete 10. The ventilator restarts in Normal mode using the default settings. Depending on the ventilator configuration, you may need to perform a calibration as described in Chapter 7.
Chapter 7 Testing, Calibration, and Performance Verification 7.4 Battery Test WARNING: To avoid the risk of fire, use only Respironics-approved batteries. All battery connectors are keyed to ensure proper connection. Do not attempt to connect a battery incorrectly. NOTE: A Low Battery or Battery Depleted alarm during the pre-operational check indicates that the battery must be charged.
The utility software requires you to use COM1 on the service PC. Do not connect or use the BiPAP Focus USB cable while connected to a docking station. Do not connect the BiPAP Focus USB cable through a USB hub.
Downloading System Calibration Software Follow these steps to download the most current calibration software to the service PC, then perform the calibration procedure: 1. From the service PC, go to http://my.respironics.com and click on Service Software (Figure 7-8). Figure 7-8: Select Service Software...
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Testing, Calibration, and Performance Verification 2. Click on Utility Tools (Figure 7-9). Figure 7-9: Select Utility Tools 3. At BiPAP Focus Calibration Software click Download (Figure 7-10). Figure 7-10: BiPAP Calibration Software 4. When the download is complete, extract the file BiPAP-Focus- Calibration_Software.exe and launch the installation wizard.
7.6.2 Performing the System Calibration The calibration procedure provides instructions for the remote calibration of the BiPAP Focus. The results of this calibration must be printed to a local printer. NOTE: The real-time clock calibration (section 7.5) must be complete before attempting the system calibration procedure.
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11. At the prompt, enter the ventilator model number and click OK. 12. Enter operator name and click OK. 13. Verify that the label is BiPAP Focus and click PASS. 14. The program runs an alarm test: follow the onscreen instructions.
EMC purposes only. The Protective Earth system is within the power supply unit as it has no conductive exposed parts. The accessible functional earth is allowed by IEC 60601-1 because the BiPAP Focus meets enclosure leakage and separation requirements. It should be noted that the ground impedance test per IEC 601 is a type test and not a production line or routine safety test.
O, EPAP = 5 cmH O, Rate = 10 BPM, and I-Time = 2.0. 7. Verify that the BiPAP Focus switches between IPAP and EPAP. Record the results. 8. Activate the ramp time setting and set ramp time to 5 minutes.
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Chapter 8 Component Removal/Installation The BiPAP Focus ventilator has the following communications requirements: • Interprocessor communication (IPC) between the controller PCB and the user interface PCB. • Serial port for calibration and controller PCB software upgrade. • USB port for user interface PCB software upgrade.
Chapter 9. BiPAP Focus Replacement Parts List This chapter lists and illustrates the major components of the BiPAP Focus ventilator, including: • Exterior • Front panel/user interface • Ventilator interior • Electronic parts NOTE: When replacing the bottom cover, order the main cover assembly (P/N 1052538) and a main label (P/N 1031229).
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Chapter 9 BiPAP Focus Replacement Parts List Table 9-1: Complete BiPAP Focus Service Parts List (Continued) Description Quantity Part number Cover assembly, display, BiPAP Focus 1052539 Cover, display front Cover, display rear Cover, display side Cover assembly, main, BiPAP Focus...
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Chapter 9 BiPAP Focus Replacement Parts List Table 9-1: Complete BiPAP Focus Service Parts List (Continued) Description Quantity Part number Power cord, Italy 1034953 Power cord, Switzerland 1034955 Power cord, UK/Ireland 1029982 Power cord, USA 1029989 Power supply, AC/DC, 120 W, 18 V...
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24 VAC or 36 VDC at 500 mA, with a minimum current of 1 mA. Fuse type No replaceable fuses. Power cord Use the BiPAP Focus power cords listed in Chapter 9. Physical Ventilator 355 mm (H) x 290 mm (W) x 140 mm (D) dimensions 14.0 in.
Chapter 10 Specifications 10.2 Patient Circuit The BiPAP Focus System automatically compensates for pressure drops associated with a Vision single patient use circuit and the mandatory bacteria Details filter. The pressure drop increases as restrictive elements (for example, humidifiers) are added to the circuit. Always use a manometer to verify patient mask pressure.
Guidance and manufacturer’s declaration: electromagnetic emissions, IEC 60601-1-2 + A1:2000. The BiPAP Focus System is suitable for use in the specified electromagnetic environment. The customer and/or the user of the BiPAP Focus System should ensure that it is used in an electromagnetic environment as described below:...
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Guidance and manufacturer’s declaration: electromagnetic immunity, IEC 60601-1-2 + A1:2000. The BiPAP Focus System is suitable for use in the specified electromagnetic environment. The customer and/or the user of the BiPAP Focus System should ensure that it is used in an electromagnetic environment as described below:...
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To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BiPAP Focus System is used exceeds the applicable RF compliance level above, the BiPAP Focus System should be observed to verify normal operation.
10.7 Warranty Respironics warrants the BiPAP Focus Ventilator to be free from defects in material and workmanship for a period of 12 months from the date of purchase, provided that the unit is operated under conditions of normal use as described in this manual.