Respironics BiPAP Focus Operator's Manual
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Respironics BiPAP Focus Operator's Manual

Noninvasive ventilator system
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Noninvasive Ventilator System
Operator's Manual
1027404 Rev K

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Summary of Contents for Respironics BiPAP Focus

  • Page 1 Noninvasive Ventilator System Operator’s Manual 1027404 Rev K...
  • Page 2 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.

  • Page 3: Table Of Contents

    About BiPAP Focus ........
  • Page 4 Care and Maintenance....... . 57 Storing the BiPAP Focus........59 Cleaning the Reusable Air Inlet Filter .
  • Page 5 Physical ..........72 Power .
  • Page 6 This page is intentionally blank. BiPAP® Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 7: System Description

    (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.

  • Page 8: Intended Use

    Environments of use: Hospital, subacute and intrahospital transport under qualified clinician direction and supervision Contraindications The BiPAP Focus System is contraindicated for patients with any of the following conditions: • Lack of spontaneous respiratory drive • Inability to maintain a patent airway or adequately clear secretions •...

  • Page 9: Warnings

    WARNING: The BiPAP Focus System should not be used adjacent to or stacked with other equipment. If adjacent use is necessary, the BiPAP Focus System should be observed to verify stable orientation and normal operation.
  • Page 10 WARNING: Do not use this device with anesthetic gases. WARNING: Do not use flammable disinfectants on or near this device. WARNING: Before using the BiPAP Focus System on a patient, allow the device to acclimate to conditions of use following transport or storage.
  • Page 11 WARNING: Do not use a Heat and Moisture Exchanger (HME) with the BiPAP Focus due to high resistance to flow. WARNING: The BiPAP Focus System can deliver pressures up to 30 O. In the unlikely event of certain fault conditions a maximum static pressure of 42 cmH O is possible.
  • Page 12 WARNING: The DC power supply provided with the BiPAP Focus system is part of the equipment. Use only the DC power supply approved for use with the BiPAP Focus system. Failure to use the approved DC power supply can result in improper operation or failure of the BiPAP Focus system.
  • Page 13 Only a qualified service technician can assure that the BiPAP Focus system is properly serviced for safe operation. WARNING: Do not connect any device other than remote alarm cables if the unit is on a patient.
  • Page 14 Warnings This page is intentionally blank. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 15: Setup

    Setup Chapter 3: Setup When unpacking the BiPAP Focus System, ensure that all parts listed on the packing list are included in the shipment. Inspect all parts for damage before use, and immediately report any discrepancies to your Respironics representative.

  • Page 16: Lifting The Bipap Focus Unit

    Figure 1: Lifting the BiPAP Focus Unit After removing all packaging materials, remove the protective plastic cover from the display, and wipe the exterior of the BiPAP Focus clean with a damp cloth and mild detergent solution before the first use (see “Care and Maintenance”...
  • Page 17 Setup 2. Turn the unit over, remove the two battery compartment cover screws, and battery cover as shown in Figure 2. Battery compartment cover Figure 2: Remove the battery compartment cover. 3. Remove the battery pack. Connect the battery by plugging the white-keyed battery cable connector into the keyed slot.

  • Page 18: Mounting

    Setup Mounting The BiPAP Focus System can be placed on a flat surface or secured to a stand as seen in Figure 4. WARNING: If placing the BiPAP Focus System on a flat surface or the stand, ensure that the surface is stable.

  • Page 19: Connecting To Power

    DC power supply can result in improper operation or failure of the BiPAP Focus system.The DC power supply provided with the BiPAP Focus system is part of the equipment. Use only the DC power supply approved for use with the BiPAP Focus system.
  • Page 20 To AC power Figure 5: Connecting to AC (Wall) Power NOTE: The BiPAP Focus System is shipped with the battery disconnected. The battery must be connected before the BiPAP Focus System will operate. Connect battery during initial setup (see page 11).

  • Page 21: Connecting To An External Device

    Most nurse call station systems require only normally open (NO) or normally closed (NC) connections. NO and NC nurse call station cables are available from Respironics. See “Accessories” on page 87 for cable ordering information. See “Specifications” on page 67 for pinout information.
  • Page 22 Setup CAUTION: The nurse call station port is intended to connect only to a SELV (Safety Extra-Low Voltage) and ungrounded system with basic insulation to ground, in accordance with IEC 60601-1. To prevent damage to the nurse call circuit, the signal input should not exceed the maximum rating of 24 VAC (Volts of Alternating Current) or 36 VDC (Volts of Direct Current) at 500 mA (milliamps), with a minimum current of 1 mA.

  • Page 23: Installing Air Inlet Filters

    Figure 7: Installing Air Inlet Filters Language Selection The following instructions describe how to select the desired language that the BiPAP Focus will display in Normal Mode. WARNING: The patient should be disconnected if operating in any mode other than Normal operating mode.
  • Page 24 Setup 4. The unit will power up and will display the following screen: Figure 8: Warning Screen 5. Press ENTER to continue past the Warning screen. The Menu screen shown in Figure 9 will appear: Figure 9: Menu Screen 6. Scroll using the DOWN arrow key until System Settings is highlighted, and then press ENTER.
  • Page 25 Setup 7. Press ENTER again to display a list of available languages (Figure 10). Use the UP and DOWN arrow keys to scroll through the list. Highlight the desired language, and then press ENTER to select that language. Figure 10: System Settings Screen 8.

  • Page 26: Connecting The Patient Circuit

    WARNING: Do not use a Heat and Moisture Exchanger (HME) with the BiPAP Focus due to high resistance to flow. The BiPAP Focus System patient interface (Figure 13) includes: • Patient interface (nasal or full face mask) •...
  • Page 27 Setup Proximal pressure mounting post Proximal pressure line Bacteria filter The use of this filter is mandatory. Figure 12: Attaching the pressure tube and filter Breathing circuit connection Bacteria filter (mandatory) Breathing circuit tubing (to patient interface) Proximal pressure line (not used) Figure 13: Patient Circuit WARNING: Use of the bacteria filter at the outlet port of the machine...

  • Page 28: Connecting Supplemental Oxygen

    If required, connect supplemental oxygen to the patient circuit as shown (Figure 14). Bleed in oxygen at the outlet of the BiPAP Focus System, using Respironics-supplied oxygen enrichment adapter and bleed-in safety valve (see “Accessories” on page 87). The oxygen flow into the oxygen valve must not exceed 15 L/min.
  • Page 29 Setup Sample FiO values for different tidal volumes with RR=20 I:E = 1:2 10L/ min patient leak, and using a Vision Circuit with IPAP/EPAP settings of 10/5,20/5,30/5. Table 1: Oxygen Concentration @ 5 L/min @ 10 L/min Tidal Volume (mL) Supplemental Flow Supplemental Flow 37 +/- 3%...
  • Page 30 Setup This page is intentionally blank. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 31: Operation

    Operation Chapter 4: Operation Pre-Operational Check The Pre-Operational Check is a check of LEDs and alarms to be used at the discretion of the clinician. This test is recommended and may be useful for initial setup or following storage periods. WARNING: Do not perform the Preoperational Check with a patient attached.
  • Page 32 Operation CAUTION: To prevent the premature depletion and reduced life expectancy of the battery, store the ventilator with AC power connected and the ON/OFF switch in the ON (I) position. When the ventilator is stored disconnected from AC power with the power ON/OFF switch ON (I) and in standby, the battery may become depleted within two weeks.

  • Page 33: System Startup

    • The nurse call station alarm activates. Pre-Operational Check is complete. System Startup Once the BiPAP Focus System is set up, follow these steps to start operation: 1. Confirm that the back panel ON/OFF switch is in the ON ( | ) position.

  • Page 34: Normal Operation

    Operation Normal Operation The BiPAP Focus System features these operating modes: Continuous Positive Airway Pressure (CPAP) Mode Provides a single level of positive pressure through the patient interface. Spontaneous/Timed (S/T) Mode Provides two levels of positive pressure (one during inspiration and another during exhalation) through the patient interface.
  • Page 35 Operation Airflow turned on Ramp time IPAP setting entered Pressure CPAP/EPAP Pressure Ramp Start Setting 0 cmH Ramp Time Minutes Figure 16: Ramp Time and Ramp Start Settings ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 36: Auto-Trak™ Sensitivity Function

    The ventilator monitors flow through the patient circuit to determine whether the patient is inhaling or exhaling using Digital Auto-Trak™ Sensitivity technology. The BiPAP Focus System adjusts its output to support breathing and compensates for normal leaks in the patient circuit using Digital Auto-Trak™...
  • Page 37 Operation • The spontaneous expiratory threshold (SET) algorithm (Figure 18) raises the threshold in proportion to the inspiratory flow rate for each breath. When the SET and actual patient flow value are equal, the system cycles to EPAP. • Maximum inspiratory time: A maximum IPAP time of 3.0 seconds acts as a safety mechanism to limit the time spent at the IPAP level during spontaneous breathing in S/T mode.

  • Page 38: System Shut Down

    Operation IPAP PRESSURE EPAP Spontaneous Expiratory Threshold FLOW Figure 18: Spontaneous Expiratory Threshold System Shut Down WARNING: Failure to enter Standby mode before switching the ON/ OFF switch on the back of the unit to the OFF position (O) will cause the unit to alarm for two minutes indicating the unit was not powered off correctly.
  • Page 39 Operation 3. If AC power is unavailable, store the ventilator with ON/OFF switch set to OFF (O) and disconnected from AC power. Always recommended: Recommended only if AC Not recommended: Battery charging and power is unavailable Battery NOT charging storage Figure 19: Battery Charging and Storage ®...

  • Page 40: The Bipap Focus Front Panel

    The BiPAP Focus Front Panel Figure 20 shows the English version and Figure 21 shows the international version of the BiPAP Focus front panel. Table 2 summarizes the functions of the front panel elements. WARNING: To avoid damage to the keypad, do not use pens or other sharp objects to change settings.
  • Page 41 Operation Table 2: BiPAP Focus System Front Panel Controls English Int’l Description ALARM indicator shows if an alarm is active (flashing) or auto-reset (steadily lit indicator). NOTE: In STANDBY mode only, an active ALARM LED indicates a missing or faulty battery or a charging circuit fault.

  • Page 42: Screen Navigation

    Operation Table 2: BiPAP Focus System Front Panel Controls English Int’l Description CANCEL clears changes. Press and hold CANCEL for 5 seconds to lock and unlock the keypad. CHANGE SCREEN steps through available screens. ENTER selects or confirms a new setting.

  • Page 43: Changing Settings

    Operation Changing Settings 1. Use the arrow keys to highlight the desired setting and press ENTER. A pop-up window for the setting appears (Figure 22). 2. Use the arrow keys to adjust the setting. 3. Press ENTER to put the new setting into effect, or press CANCEL to exit without changing the setting.

  • Page 44: Cpap Mode Settings Screen

    Operation CPAP Mode Settings Screen Figure 24 shows the CPAP Mode settings screen. Figure 24: CPAP Mode Settings Screen The CPAP screen includes these elements: Settings CPAP The level of continuous positive airway pressure delivered throughout the breath cycle. Ramp Period over which the ventilator increases inspiratory pressure Time from Ramp Start setting to CPAP setting.

  • Page 45: S/T Mode Settings Screen

    Operation Trigger Indicates whether the patient (Patient) or ventilator (Timed) is triggering a breath. Continuous display of measured patient circuit pressure. graph NOTE: ‘+++’ is displayed for any parameter outside of upper ranges. ‘---’ is displayed for any parameter outside of lower ranges. See “Specifications”...

  • Page 46: Patient Data

    Operation Ramp The initial EPAP pressure (less than or equal to the EPAP setting). Start Rate Respiratory rate, used to determine if a timed breath is delivered. I- Time and Rate settings cannot allow I-Time to exceed expiratory time. The system will reduce the I-Time automatically as required to satisfy this rule.

  • Page 47: Alarm Settings Screen

    Operation Alarm Settings Screen Figure 26 shows the Alarm Settings screen. NOTE: The system automatically selects all other alarm settings. Figure 26: Alarm Settings Screen The Alarm Settings screen includes these elements: Settings Apnea The length of time without a spontaneous breath that triggers Apnea alarm.

  • Page 48: Options Screen

    Operation Options Screen Figure 27 shows the Options screen. Figure 27: Options Screen The Options screen includes these elements: Display Selects units of pressure: centimeters of water (cmH Units hectoPascals (hPa), or millibars (mbar). Alarm Selects audible alarm volume. Volume Contrast Selects screen contrast from 20% to 100%.

  • Page 49: Battery Back-Up Operation

    Operation Battery Back-up Operation The BiPAP Focus contains an internal battery. When the internal battery is fully charged, the Battery Back-up feature allows the unit to continue operation for a limited time in the event of mains power loss or during intra-hospital transport.

  • Page 50: Battery Operating Time

    Battery charge time is typically less than 5 hours, but can be longer depending on environmental conditions (primarily temperature). It is important to maintain a fully charged internal battery in case of a mains power outage. Any time the BiPAP Focus has been in storage, a ® BiPAP Focus™...
  • Page 51 Operation full charge cycle should be run. A fully charged battery will deplete within 3 months if unused and not charged. This is the normal depletion rate when the unit is stored with the ON/OFF switch in the OFF (O) position. If the unit is left in Standby mode with the ON/OFF switch in the ON ( | ) position and it is not connected to AC mains power, the internal battery will deplete within 2 weeks.

  • Page 52: Battery Care

    BATTERY CHARGING and the ON BATTERY LEDs are illuminated simultaneously then contact Respironics Customer Service. The BiPAP Focus self tests will also indicate when the battery needs to be replaced by displaying a Batt Charge Failure message (see “Alarms” on page 47). Contact Customer Service to purchase a replacement battery.

  • Page 53: Alarms

    Alarms Chapter 5: Alarms When an alarm is active: • The ALARM indicator flashes, • The alarm message is displayed, and • The system sounds a repeating sequence of beeps. Certain alarms can be auto-reset, meaning that the system automatically resets the alarm once the alarm condition is corrected.

  • Page 54: Alarm Pre-Silence

    Alarms Alarm Pre-silence Press ALARM SILENCE when no alarms are active to silence any alarm that may occur in the two minutes following the key press. Alarm Pre- silence is useful for avoiding nuisance alarms during certain procedures. A new alarm will not sound if Alarm Pre-silence is active. Press ALARM RESET when Alarm Pre-silence is no longer required.

  • Page 55: Alarm Descriptions

    If the suggested corrective actions do not resolve the problem, provide alternate breathing support and contact a qualified service technician. Table 4: BiPAP Focus Alarms Alarm Message Description Corrective Action...
  • Page 56 Alarms Table 4: BiPAP Focus Alarms Alarm Message Description Corrective Action Battery Depleted Up to 2 minutes of battery Check connection to AC power remain. power and verify that AC (auto-resets) POWER and green Auto-resets when AC power BATTERY STATUS is connected.
  • Page 57 Alarms Table 4: BiPAP Focus Alarms Alarm Message Description Corrective Action High High temperature detected Check room temperature is Temperature inside the ventilator. within specified operating conditions. Allow the ventilator to acclimate to the ambient conditions. Key Stuck One or more of the user Check the keypad.
  • Page 58 Alarms Table 4: BiPAP Focus Alarms Alarm Message Description Corrective Action Low Battery Approximately 10 minutes Check connection to AC of battery power remain. power and verify that AC (auto-resets) POWER and green Auto-resets when AC power BATTERY STATUS is connected.

  • Page 59: Symbols

    Symbols Chapter 6: Symbols Symbol Meaning Canadian Standards Association approval. Drip-proof enclosure ingress protection. Type BF protection rating. Compliant with the Waste Electrical and Electronic Equipment (WEEE) Recycling Directive. Keep dry Fragile, handle with care. This side up. Nurse call station connection. Serial port connection.
  • Page 60 Symbols Symbol Meaning ON/OFF switch (press “O” to turn OFF; press “|” to turn ON). Manufacturer approved power supply for use with the ventilator. Electrical Input Gas inlet port Gas output port LOT code Serial number Catalogue number Battery (battery compartment door) Alarm indicator.
  • Page 61 Symbols Symbol Meaning Battery Status LEDs indicate that either the system is powered by internal battery power (yellow) or the battery charge cycle is active during AC operation (green). The green indicator turns off when the battery is fully charged during AC operation.
  • Page 62 Symbols This page is intentionally blank. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 63: Care And Maintenance

    WARNING: Maintenance and service work not listed in this chapter shall only be performed by a qualified service technician. Only a qualified service technician can assure that the BiPAP Focus system is properly serviced for safe operation. Table 5 summarizes maintenance procedures for the BiPAP Focus System.
  • Page 64 Care and Maintenance Table 5: BiPAP Focus System Maintenance Part Interval Procedure Air inlet Reusable: clean Follow the “Cleaning the Reusable Air filter(s) monthly or as Inlet Filter” on page 8. needed. Replace. Reusable: every year or as needed. Do not attempt to clean or reuse Disposable: replace disposable filters.

  • Page 65: Storing The Bipap Focus

    Care and Maintenance Storing the BiPAP Focus 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.

  • Page 66: Cleaning The Reusable Air Inlet Filter

    Figure 30: Reusable Air Filter Filter door Reusable air inlet filter (gray) CAUTION: Never reinstall a wet filter. CAUTION: Use only Respironics-approved filters. CAUTION: Replace any filter that is damaged. CAUTION: Do not attempt to clean or reuse disposable air inlet filters. ® BiPAP Focus™...

  • Page 67: Replacing The Air Inlet Filter(S)

    Care and Maintenance Replacing the Air Inlet Filter(s) WARNING: It is important to inspect and replace the air inlet filters at the recommended intervals to avoid introducing foreign matter into the system The reusable air inlet filter (gray) must be installed and replaced every year.
  • Page 68 Care and Maintenance 6. The unit will power up and will display the following screen. Figure 31: Warning Screen 7. Press ENTER to continue past the Warning screen. The Menu screen will appear: Figure 32: Menu Screen ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...
  • Page 69 Care and Maintenance 8. If the blower is on, turn it off as follows: a. Scroll using the DOWN arrow key until System Test is highlighted, and then press ENTER. The System Test screen shown in Figure 4 will appear. Figure 33: System Test Screen b.
  • Page 70 Care and Maintenance b. Record the VBATT reading. 11. Press CHANGE SCREEN to return to the Menu screen. 12. Turn the blower on by repeating step 8, but setting Blower to On. 13. Wait 1 minute for the VBATT reading to stabilize. Record the VBATT reading by repeating step 10.

  • Page 71: Replacing The Battery

    Care and Maintenance Replacing the Battery WARNING: To avoid the risk of fire, use only Respironics-approved batteries. All battery connections are keyed to ensure proper connection. Replace the battery (Figure 35) if a Batt. Charge Failure alarm occurs, or as indicated in “Battery Care” on page 46.
  • Page 72 Care and Maintenance 5. Replace the battery compartment door and screws. 6. Reconnect the DC power supply. WARNING: Use only Respironics recommended batteries. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 73: Specifications

    Specifications Chapter 8: Specifications Default Settings S/T mode RR = 4/min IPAP = 12 I-Time = 1 sec EPAP = 4 Ramp Time = 0 min Rise-Time = 2 Ramp Start = 4 cmH Settings: CPAP Mode CPAP Range: 4-20 cmH O (4-20 hPa) Continuous Resolution: 1 cmH...

  • Page 74: Settings: S/T Mode

    Specifications Settings: S/T Mode IPAP Range: 4-30 cmH O (4-30 hPa) Inspiratory Resolution: 1 cmH O (1 hPa) positive airway Dynamic accuracy: ±5 cmH O (5 hPa) pressure, the inspiration IPAP cannot be set below EPAP. pressure setting EPAP Range: 4-25 cmH O (4-25 hPa) Expiratory Resolution: 1 cmH...

  • Page 75: Measured Data

    Specifications Settings: S/T Mode I-Time Range: 0.5-3 sec Inspiratory time 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 Range: 4 cmH...

  • Page 76: Alarm Settings

    Specifications Measured Data Est. Vt Range: 0-4000 mL Estimated Resolution: 1 mL delivered tidal Accuracy (S/T Mode): ± (50 mL + 10% reading) (when leak volume <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.

  • Page 77: Options

    Specifications Alarm Settings #Apnea Range: 5, 10, 20, or OFF The number of periods (10-seconds or more) in Default setting: OFF the previous hour where the patient has not initiated a spontaneous breath. NOTE: For the first hour, this value is an estimate only.

  • Page 78: Physical

    • 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 355-mm H x 290-mm W x 140-mm D (14.0-in.

  • Page 79: Power

    VDC (Volts of Direct Current) at 500 mA (milliamps), with a minimum current of 1 mA. Fuse type No replaceable fuses. Power cord Use the BiPAP Focus System only with the following power cords: Europe: Plug type CEE 7/7 (P/N 1029985) UK/Ireland: Plug type BS 1363...

  • Page 80: Patient Circuit Details

    Specifications Patient Circuit Details Pressure Drop Versus Flow for Patient Circuits The BiPAP Focus System automatically compensates for pressure drops ® associated with a Vision single patient use circuit and the mandatory bacteria filter (see “Accessories” on page 87 for ordering information).

  • Page 81: Maximum Pressure Drop For Disconnect

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

  • Page 82: Bacteria Filter

    Specifications Bacteria Filter Dead space 68 mL Bacteria/viral filter >99.99% efficiency P/N 342077 Resistance 0.7 cmH O/L/s at 0.5 L/s Connectors Male connector 15-mm I.D./22-mm O.D. 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.

  • Page 83: Pneumatics

    Specifications Pneumatics BiPAP Focus System pneumatic diagram: Diffuser BiPAP Focus System Bacteria filter Air inlet (mandatory) Flow sensor filter Patient circuit (to mask outlet) Blower Control (motor) valve Air inlet Muffler port Tubing (elbow) Oxygen adapter Pressure sensor (if using oxygen)
  • Page 84 Specifications This page is intentionally blank ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 85: Compliance

    Compliance Chapter 9: Compliance International Standards • IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment Part 1: General Requirements for Safety, plus 1st and 2nd Amendments to the standard •...

  • Page 86: Electromagnetic Emissions

    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...
  • Page 87 Compliance 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: IEC 60601 Compliance...
  • Page 88 NOTE: UT is the AC mains voltage prior to application of the test level. Guidance and manufacturer’s declaration: electromagnetic immunity, IEC 60601-1-2. The BiPAP Focus System is suitable for use in the specified electromagnetic environment. The customer and/or the user of the BiPAP BiPAP® Focus™ Noninvasive Ventilator System...
  • Page 89 Portable and mobile RF 150kHz to communications equipment should IEC 61000- 80MHz be used no closer to any part of the BiPAP Focus System, including cables, than the recommended Radiated RF 3 V/m 3 V/m separation distance calculated IEC 61000-...
  • Page 90 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.
  • Page 91 Compliance Recommended separation distances between portable and mobile RF communications equipment and the BiPAP Focus IEC 60601-1-2: Frequency of 150 kHz to 150 kHz to 800 MHz to 2.5 transmitter 80 MHz 800 MHz Equation d = 1.2 d = 1.2 d = 2.3...
  • Page 92 Compliance This page is intentionally blank. BiPAP® Focus™ Noninvasive Ventilator System 1027404 Rev K...

  • Page 93: Accessories

    Accessories Chapter 10: Accessories Use the BiPAP Focus System with the following Respironics accessories. Please contact your local Respironics representative before using other accessories with the BiPAP Focus System. Description Order Code BiPAP Focus Ventilator System Contact your Respironics Contact your local dealer for complete part number, which is representative determined by country and configuration.
  • Page 94 Accessories Description Order Code Nurse call station cable, BiPAP Focus, normally open (NO), 1027713 50 ft. Operator’s Manual, BiPAP Focus System, English 1027404 Service Manual, BiPAP Focus System 1029568 Power supply, DC, BiPAP Focus System 1025775 Universal roll stand (also requires BiPAP Focus mounting...

  • Page 95: Warranty

    12 months from the date of purchase, provided that the unit is operated under conditions of normal use as described in this manual. At its discretion, Respironics will make replacements, repairs, or issue credits for equipment or parts that are found to be defective.
  • Page 96 Warranty This page is intentionally blank. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...
  • Page 97 Respironics welcomes your feedback. ® BiPAP Focus™ Noninvasive Ventilator System 1027404 Rev K...
  • Page 98 Please help us provide you with the best ventilation systems available by letting us know what you think. Philips Healthcare Customer Service In the United States: +1-800-345-6443 Outside the United States: +1-724-387-4000 Fax: +1-724-387-5012 email: respironics.service@philips.com or respironics.clinical@philips.com www.philips.com/healthcare ® BiPAP Focus™ Noninvasive Ventilator System...

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