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Modes In order to prevent the patient from changing the settings, the Home Mode should be activated before giving the Vivo 50 to the user. Home Mode locks treatment settings, alarm limits and other selected information. The Clinical Mode is used by the clinician to access all mode choices, settings and limits.
Monitored Values in the Vivo 50 ..............54 Functions and Parameters in the Vivo 50 ............59 Modes in the Vivo 50..................81 Transferring Data between the Vivo 50 and a PC........... 90 Using Batteries....................91 Using Accessories................... 99 Alarms......................... 109 Alarm Function ....................
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Cleaning and Maintenance ..................158 Cleaning the Vivo 50 ..................159 Cleaning and Replacing the Patient Air Filters..........160 Change of Patient ..................161 Regular Maintenance Control ............... 161 Service and Repair..................162 Storage ......................162 Disposal ......................162 Technical Specifications ..................... 163 System Description ..................
Every other use may lead to risk of personal injury! CAUTION! Read this operating manual thoroughly so that you completely under- stand how the Vivo 50 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and ser- viceability. Non-professional caregivers (e.g., family members) should consult the medical equipment provider’s respiratory thera-...
Ventilation • CPAP – Continuous Positive Airway Pressure The Vivo 50 can be used with a leakage circuit, circuit with active exhala- tion valve or circuit with mouthpiece interface. The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software.
The Vivo 50 is not intended to be used as a transport and critical care ventilator. 1.3 Contraindications • The use of the Vivo 50 is contraindicated for patients who need to be ventilated with oxygen concentrations (FiO ) higher than achievable when combining inlet from a low pressure oxygen source at 15 l/min with actual ventilator settings.
1.4 About this Manual Always read this manual before setting up and using the Vivo 50 or per- forming maintenance on the machine, to ensure correct usage, maxi- mum performance and serviceability. Audience This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 50 system.
• The Vivo 50 must be switched off and on at least every 90 days. This is necessary in order for the Vivo 50 to perform a complete self-test.
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• Clinical personnel must read the manual thoroughly and understand the Vivo 50 operation before setting up and using the machine. • All the physiological alarms of the Vivo 50 must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient settings.
2.2 Electrical Safety • Do not operate the Vivo 50 if it has a damaged power cord or casing. • To avoid electrical shock, disconnect the electrical supply to the Vivo 50 before cleaning. Do not immerse the Vivo 50 into any fluids.
• Do not use the Vivo 50 in environments where there are explosive gases or other flammable anesthetic agents present. • The air flow for breathing produced by the Vivo 50 can be as much as 7°F (4°C) higher than room temperature. Caution should be exer- cised if the room temperature is greater that 97°F (36°C).
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• Do not use the Vivo 50 while positioned in a warm place, such as direct sunlight or close to a radiator. • The device complies with the EMC requirements of standards listed in “Compliance of Standards” on page 185. Necessary measures...
• Do not use patient hoses or tubes made of static or electrically con- ductive material. • Always use a new patient circuit when the Vivo 50 is to be used by a new patient. • Always make sure that the patient circuit and joined parts are undam- aged and correctly connected, in order to avoid unwanted leakage.
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• Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the Vivo 50 to ensure no water flows back into the Vivo 50. The frequency at which these checks must be performed will depend on the patient’s own condition and the device used.
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• Always follow the instructions of the mask manufacturer. • The Vivo 50 is equipped with a rebreathing alarm. The alarm is not a substitute for operator vigilance in ensuring that the leakage port or exhalation valve remains clear at all times.
• When operating the Vivo 50, make sure that the air inlet and filters are not obstructed or occluded. • If the Vivo 50 is used in a clinic by several patients, a low resistance bacterial filter is recommended between the air outlet and the patient circuit to prevent patient cross-contamination (Breas Medical AB recommends the low resistance bacterial filter part no.
• Any humidifier connected to the Vivo 50 must comply with ISO 8185. • Any HME connected to the Vivo 50 must comply with ISO 9360. • The use of an HME or an external humidifier may require readjust- ment of the Vivo 50 low-pressure alarm.
Breas Medical AB. • Do not under any circumstances attempt to open, service or repair the Vivo 50 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 50. Further- more, no guarantees will be valid.
(part no. 005988) is rec- ommended. • When oxygen is used with the Vivo 50, the oxygen flow must be turned off when the Vivo 50 is not operating. Oxygen delivered into the patient tubing may accumulate within the machine enclosure.
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• Supplemental oxygen flow must not exceed 15 l/min. • The oxygen concentration in the delivered air has influence on the volume measurement of the Vivo 50. This measurement is based on a normal oxygen concentration of 21%. If the oxygen concentration...
Product Description 3.1 Main Components The Vivo 50 system contains the following components: 20 Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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004970 mation Filter (white, dis- Inlet air filtration 004910 posable) Filter (grey, dispos- Inlet air filtration 004909 able) Power cord 005432 Click-on battery 004559 Vivo 50 main unit * Optional Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
3.2 The Vivo 50's Front Panel 13 14 UNCTION Trigger Patient triggered breath indication Power source: AC External DC Power source: External DC Click-on battery Power source: Click-on battery Internal battery Power source: Internal battery Alarm (red & yellow) Alarm indication...
3.3 The Vivo 50's Side Panels 3 4 5 11 12 13 14 15 16 17 UNCTION OLOUR Patient air inlet Air path in, replaceable filters Cooling air inlet Inlet internal cooling Nurse call Connection for nurse call Remote alarm...
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Exhalation valve Connection for exhalation control pressure valve control pressure tube outlet Patient air outlet Connection for patient circuit Oxygen inlet port Connection for low pressure/ bleed-in oxygen source 24 Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
40 - 50 YMBOL XPLANATION OLOUR interface port interface port iOxy interface port Remote Start/Stop, audio pause Attention: Read the chapter “Connecting the Vivo 50 to AC Power” on page 31. Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Attention: Make sure that nothing can block the patient air inlet on the side of the Vivo 50. Read “Placing the Vivo 50” on page 30 for more information. Internal battery Product number 26 Product Description Vivo 50 Operating manual Doc.
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Body floating (IEC 60601-1 Type BF, Iso- lated Applied Part) (Symbol only applicable in U.S.) Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed health- care practitioner. Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Conforms to CAN/CSA-C22.2 No. 601.1- M90, including AM1+AM2. CE marking applies in accordance with the directive MDD 93/42/EEC. Click-on battery CE marking applies in accordance with the directive MDD 93/42/EEC. Click-on battery instructions 28 Product Description Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
Ensure that the equip- ment is in good condition. If stored more than 1 month, connect the Vivo 50 to the power sup- ply to recharge the internal battery (see “Charging the Batteries” on page 92 for further instructions).
Make sure that nothing can block the patient air inlets on the side of the Vivo 50. Do not place the Vivo 50 on a soft surface that will prevent the air flow underneath the device. Never cover the device.
4.3 Connecting the Vivo 50 to AC Power Read the chapter “Electrical Safety” on page 9 carefully to make sure all conditions are considered and met. Plug the power cord into the power inlet of the Vivo 50. Secure the power cord using the restraining clip.
• Make sure that the correct patient circuit type is selected when con- necting a patient circuit. “Select Patient Circuit Type” is located in the Others section of the Vivo 50 display when the ventilator is in standby. • In MPV breath mode the patient circuit type setting is not available.
• Check that the cables are properly connected. Inspection of Placement • The Vivo 50 shall be placed on solid flat surface below the patient level (see “Placing the Vivo 50” on page 30). • Make sure that nothing can block the air inlet at the side.
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Connect a patient circuit to the Vivo 50. Connect the Vivo 50 to the power source. Switch on the Vivo 50 main power using the On/Off switch on the side panel. Ensure that the treatment settings and alarm settings are adjusted as prescribed, and that the correct patient circuit type is selected.
4.6 Adjusting the Vivo 50’s Patient Settings The configuration of the Vivo 50 therapy settings must always be pre- scribed by a licensed physician and carried out by an authorized health care professional. For detailed information about the treatment parameters of the Vivo 50, see “Functions and Parameters in the Vivo 50”...
Always perform a new pre-use test if the patient circuit configuration is modified. If the pre-use test has not been performed, the Vivo 50 will operate with default patient circuit compensation. The pre-use test can be performed directly from the Others menu of the Vivo 50 display, where step-by-step instructions are shown.
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CTION Wait while the Vivo 50 is checking the patient circuit resist- ance. Block the end of the patient circuit with an air tight object. Wait while the Vivo 50 is checking the patient circuit compli- ance and leakage. Confirm if the patient circuit type is correct.
Read the chapter “Safety Information” on page 7 before using the Vivo 50. When the Vivo 50 is handed over to the patient, the physician in charge or hospital staff must instruct the patient in how the unit works. 5.1 Switch the Vivo 50 On and Off...
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Press the On/Off button on the side panel within 10 seconds. Press the button firmly. When the Vivo 50 is in standby mode you press the On/Off but- ton on the side panel to switch off.
Use the “-” and “+” buttons to alter parameters, or enter and exit sub sections. 40 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Multiple pages Multiple content available High priority alarm event in history list Medium priority alarm event in history list How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Overview Menu Clinical Mode In Clinical Mode, the Vivo 50 menu has the following section layout: Icon explanation Mode Ventilation & Breath Mode Change Guided setup Device Mode Change Page Reset to basic settings Sub menu Setup Setup 1-2 (Home Adjust Limits)
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Home Mode In Home Mode, the Vivo 50 menu has the following section layout: Main Setup Setup 1-2 Alarm Alarm Settings 1-2 Alarm/Event History Monitor Others Device memory Patient Operating Time Device Settings Time and Date Device Information How to Use the Vivo 50 Vivo 50 Operating manual Doc.
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The Vivo 50 Display 44 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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3. Icon/Alarm Message Information icons are presented here to give a quick overview of the Vivo 50 basic status (see “Symbols Used in the Menu” on page 41). 4. Monitoring Field This field is designed to give a brief overview of the key monitor values.
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The device mode can be set to Clinical Mode or to Home Mode, with lim- ited patient adjustments. Read “Modes in the Vivo 50” on page 81 for more detailed information about the different modes of the Vivo 50. 46 How to Use the Vivo 50 Vivo 50 Operating manual Doc.
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The Setup Section In the Setup section, treatment parameters can be altered. See “Functions and Parameters in the Vivo 50” on page 59. If Home Adjust is set to “On” in the Others section (see “Home Adjust” on page 51), the Setup section will contain an additional page. In this page, the Min and Max limits for Home Adjust can be altered.
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Vivo 50 is operating in Home Mode. The Alarm Section In the Alarm section, the alarm parameters can be altered (see “Alarms” on page 109 for more information). The Alarm/Event History screen displays all events that have been logged, as well as alarms that have occurred.
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(in most other screens, except for the curve and trend view, a small monitoring field is displayed with 8 values). See “Monitored Values in the Vivo 50” on page 54 for a description on the monitored val- ues.
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Use the up and down buttons to select a value, and use the “-” and “+” buttons to alter scale or time period. 50 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Home Adjust If Home Adjust is set to “On” in the Others section, the user can adjust certain treatment parameter when the Vivo 50 is operating in Home Mode. These parameters will have a limited setting range that is prede- fined by the care provider.
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Patient Operating Time Shows the number of hours a patient has been using the Vivo 50 for breathing therapy. Use “Reset Patient Operating Time” to reset the coun- ter to 0.
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Device Information • Device Operating Time (hours) • Firmware Version • Language Package • Lang. Package Version • AC (On/Off) • External DC (V) • Serial Number How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
5.3 Monitored Values in the Vivo 50 Values monitored by the Vivo 50 can be found in: The monitoring screen Right hand side field in curve and trend screens The monitoring field peak The P displays the highest pressure that peak is recorded during the inspiratory phase.
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This value is only displayed in the monitor- ing field if the patient circuit type is Exhala- tion valve or if MPV breath mode is used. The Vivo 50 is suitable for treatment of patients that require a minute volume between 1 and 30 litres. The MV...
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Vivo 50. A FiO sensor (part no. 005988) needs to be in place to measure and display this value (see “Using the Vivo 50 with the FiO2 Sensor” on page 100). % in TgV The % in TgV displays the percentage of breaths where the actual delivered Tidal Vol- ume matches with the set Target Volume.
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The SpO displays the patient’s oxygen satu- ration as measured with Breas iOxy module. • The oximeter in the Vivo 50 is calibrated to display functional oxygen saturation. • For data regarding the oxygen probe’s range of peak wavelengths, max optical power and usage, please refer to the respective probe manual.
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EtCO sensor. InspCO The InspCO displays the inspired carbon dioxide. 58 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
5.4 Functions and Parameters in the Vivo 50 All the parameters used for controlling the breathing by the Vivo 50 are listed below. Inspiratory Pressure (Insp. Pressure) ESCRIPTION Definition The Inspiratory Pressure setting is used to define the airway pressure during the inspir- atory phase.
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O , Pressure -2 cmH O or Min Pressure -2 cmH Setting resolution 0.5 below 10 cmH 1.0 above 10 cmH Position Setup (Clini- cal Mode and Home Mode) 60 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Breath Rate ESCRIPTION Definition The Breath Rate setting defines the mini- mum number of breaths the Vivo 50 will deliver as long as no inspiratory trigger effort from the patient is detected. The cycles will be ventilator-initiated breaths. The combination of the Breath Rate and Inspiratory Time setting is limited by the I:E ratio 2:1.
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2:1. Modes PCV-SIMV, VCV-SIMV Setting min 4 bpm Setting max 40 bpm Setting resolution 1 bpm Position Setup (Clini- cal Mode and Home Mode) 62 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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PCV, PCV(TgV), PCV(A), PCV(A+TgV), PCV-SIMV, PCV-MPV, VCV, VCV(A), VCV-SIMV, VCV-MPV Setting min 0.3 s Setting max Setting resolution 0.1 s Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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I:E ratio 2:1. Modes PSV, PSV(TgV) Setting min 0.3 s Setting max Setting resolution 0.1 s Position Setup (Clini- cal Mode and Home Mode) 64 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Limited to 50 cmH O or 2500 ml. Setting resolution 50 breaths (frequency). 25% (pressure and volume) Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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9 (PSV & PCV, PCV-SIMV, PCV-MPV, VCV-SIMV) 90% of the inspiration time, Off (=100%) (VCV, VCV-SIMV, VCV-MPV) Setting resolution 1 (PSV & PCV), 10% (VCV) 66 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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ESCRIPTION Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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9, Off (PCV & VCV) Setting resolution 1 (setting 1 is the most sensitive and 9 is the least sensitive) Position Setup (Clini- cal Mode and Home Mode) 68 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Setting min 4 cmH Setting max 50 cmH Setting resolution 0.5 below 10 cmH 1.0 above 10 cmH Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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9 (90% decrease of peak flow) Setting resolution 1 (setting 1 is the most sensitive and 9 is the least sensitive) Position Setup (Clini- cal Mode and Home Mode) 70 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Expiratory Trigger. Modes PSV, PSV(TgV) Setting min Off, 0.3 s Setting max Setting resolution 0.1 s Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Expiratory Trigger. Modes PSV, PSV(TgV) Setting min 0.3 s Setting max 3 s, Off Setting resolution 0.1 s Position Setup (Clini- cal Mode and Home Mode) 72 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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ESCRIPTION Definition The Backup Rate setting defines the mini- mum number of breaths the Vivo 50 will deliver in case of prolonged apnea and as long as no inspiratory trigger effort from the patient has been detected. The cycles will be ventilator-initiated breaths.
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ESCRIPTION Definition The Target Volume setting defines the tidal volume that the Vivo 50 will aim for while ventilating the patient in a pressure mode. To aim for the preset volume, the Vivo 50 will adapt the Inspiratory Pressure between two adjustable pressure limits: Min Pressure and Max Pressure.
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ESCRIPTION Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Vivo 50 can increase the pressure to reach the set Target Volume. If Target Vol- ume is not reached at Max Pressure, the Vivo 50 will continue to ventilate at this Max Pressure setting. Modes PSV(TgV), PCV(TgV), PCV(A+TgV)
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The Min Pressure setting is only used when Target Volume is activated. Min Pressure defines the lower pressure limit down to where the Vivo 50 can decrease the pressure to maintain the set Target Volume. If the actual volume is above Target Volume at Min Pressure, the Vivo 50 will continue to ventilate at this Min Pressure setting.
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Tidal Volume ESCRIPTION Definition The Tidal Volume setting defines the vol- ume that will be delivered by the Vivo 50 for each breath. In VCV-SIMV mode, this setting is applica- ble to the mandatory breaths that are con- trolled by the ventilator.
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Modes VCV, VCV(A), VCV-SIMV, VCV-MPV Setting range Square, Decelerating Position Setup (Clini- cal Mode and Home Mode) How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Setting min 4 cmH Setting max 20 cmH Setting resolution 0.5 below 10 cmH 1.0 above 10 cmH Position Setup (Clini- cal Mode and Home Mode) 80 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
Standby and Operating Mode Standby mode is defined as the state of the Vivo 50 when AC is con- nected and the On/Off switch is on, but without starting the Vivo 50 with the Start/Stop button.
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In case of a patient initiated breath, the patient continues the breath 82 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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The PSV(TgV) mode acts as the PSV mode but with an added regulation of the pressure. Target volume is a feature that automatically adapts the pressure to make sure that the Vivo 50 delivers the desired set target vol- ume to the patient. The delivered volume is compared to the set target volume on a breath by breath basis.
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The PCV(TgV) mode acts as the PCV mode, but with an added regula- tion of the pressure. Target volume is a feature that automatically adapts the pressure to make sure that the Vivo 50 delivers the desired set target volume to the patient. For every breath, the delivered volume is com- pared to the set target volume.
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• When switching to MPV mode all alarms, except from High/Low Pressure Alarms, are automatically switched off to avoid false alarm How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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• MPV breath mode shall not be used with ventilator dependent patients. VCV – Volume Controlled Ventilation In the VCV mode the ventilation is controlled by the Vivo 50. This is done with the preset tidal volume, breath rate, inspiratory time, and rise time settings set by the operator.
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• When switching to MPV mode all alarms, except from High/Low Pressure Alarms, are automatically switched off to avoid false alarm How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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CPAP – Continuous Positive Airway Pressure In CPAP mode the Vivo 50 is applying a continuous positive pressure to the airways. The flow will automatically be adjusted to maintain the set CPAP level. CPAP mode can only be used when a leakage circuit is selected.
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Sigh When the Sigh feature is enabled the Vivo 50 will deliver a Sigh breath as configured by the prescriber at a certain preset frequency. A Sigh is a breath where an increased % of the set pressure or volume is delivered to the patient.
In order to view and present patient data correctly, the Vivo 50 PC Soft- ware must be installed on the PC. Instructions on how to manage data in the Vivo 50 PC Software can be found in the software help.
With a USB cable, real-time data can also be received and sent between the Vivo 50 and a PC. Connect the USB cable to the Vivo 50. Make sure it is fitted cor- rectly. Connect the other end of the cable to the PC.
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Charging the Batteries Do not charge the Vivo 50 while placed in the carry bag or other types of closed or non-ventilated spaces. The batteries have no “memory effect” (with older battery types it was an advantage to fully discharge and charge the battery, otherwise they will “learn”...
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* Times are based on charging empty batteries. Battery Icons When running on battery, the battery status is indicated by the following symbols: YMBOLS ATTERY TATUS Full Medium Empty/Low Disconnected or malfunctioning Malfunctioning How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Connect the Click-on Battery Use a thin stick to open the cover for the click-on battery con- nectors. Make sure the cover is com- pletely opened. 94 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Hold the Vivo 50 as shown in the picture, in order to target the click-on battery holders (marked with circles). Tilt the Vivo 50 into an upright position. Once in position, a clicking sound should be heard. Use the screw to secure the click-on battery by pressing it in and turn clockwise.
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Connect the charger to the AC power supply. To charge an empty click-on bat- tery using the click-on battery charger takes about 3 hours. 96 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Battery Operating Time (Internal and Click-on) The operation time is dependent on the battery condition, its capacity, the ambient air temperature and the Vivo 50 pressure setting. These data are based on new and fully charged batteries. ARAMETER XAMPLE ENTILATOR SETTINGS...
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External DC Only use a battery charger compliant to IEC 60601-1 if you are charging a battery that at the same time is connected to the Vivo 50. The Vivo 50 can be operated from: • a 12 V external DC source using the 12/24 V converter (part no.
Using the Vivo 50 with a Nurse Call System The Vivo 50 can be connected to a nurse call system using the nurse call cable. When connected, the Vivo 50 alarms will also be forwarded to the nurse call system.
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<6 years (in ambient air) 1 year (in 100% O Note that the operating conditions for the FiO sensor is different from the Vivo 50 system conditions. If the sensor is used outside its operating conditions the FiO measurements might deviate. Cleaning Do not clean, disinfect or autoclave the sensor, T-piece or cable.
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The Remote Alarm enables care providers and clinical personnel to mon- itor the Vivo 50 alarms remotely. The Remote Alarm forwards alarms from the Vivo 50. When an alarm sounds, the care provider or clinical personnel must attend to the patient quickly.
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• Measurements can be affected by mobile and RF communications equipment. It should be assured that the CO sensor is used in the electromagnetic environment specified in the Vivo 50 Service Man- ual. • Do not place the airway adapter...
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Sensor Connect the CO sensor cable to the CO connection port on the Vivo 50 (according to the instruction “Connecting and Disconnecting the Cables” on page 99). A green LED indicates that the CO sensor is ready to use. Snap the CO sensor probe on top of the airway adapter.
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LED S TATUS ESCRIPTION Steady green light System OK Flashing green light Zeroing in progress Steady red light Sensor error Flashing red light Check adapter 104 How to Use the Vivo 50 Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Vivo 50 is sent for service. See the Vivo 50 service manual for how to perform the gas span check. Do not under any circumstances attempt to service or repair the CO sen- sor yourself.
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The iOxy, consisting of a SpO2 sensor, an electronic unit and cable, is intended to measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The iOxy sensor can be connected to the Vivo 50 in order to monitor and store SpO measurements. The SpO...
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Using the Vivo 50 with the Trolley Mount and dismount the Vivo 50 as shown in the picture: • Be careful when handling the trolley with the ventilator mounted, in order to avoid any risk of the trolley falling. The trolley can be tipped 10°...
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The protective cover is intended for additional protection of the Vivo 50 during transportation, and in hospital, institutional and home care envi- ronments. It can be used while the Vivo 50 is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand.
The alarm function of the Vivo 50 consists of the alarm LEDs on the front panel, an audible alarm, and messages on the display (see “The Vivo 50's Front Panel” on page 22 for an overview of the position of the LEDs).
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• The power failure alarm sounds in the case of power failure. • If the internal battery falls below the warning limit and it is the last power source, the Low Last Power Source alarm is displayed. 110 Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
For receiving the visual part of an alarm and its priority, the operator’s position should be within a distance of 13 feet (4 meters) from the Vivo 50, and within an angle of 30° to the normal of the Vivo 50 display. Alarms Vivo 50 Operating manual Doc.
6.3 Physiological Alarms The physiological alarms of the Vivo 50 are related to the treatment parameters of the ventilator. High Pressure Alarm ESCRIPTION Definition A High Pressure alarm will be given when the pressure reaches the set High Pressure alarm limit for 3 consecutive breaths during inspira- tion.
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(max 60 cmH • In volume modes (during the sigh breath), the high pressure alarm will automatically be increased by the same percentage as the set sigh volume percentage (or max 60 cmH Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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ESCRIPTION Definition A Low Pressure alarm will be given when the Vivo 50 pressure fails to reach the low pressure alarm limit for 15 ±0.5 seconds. In MPV breath mode the alarm will be given when the pressure fails to reach the limit during inspiration.
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ESCRIPTION Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message. Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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• Blocked exhalation valve or leakage port. Setting range On, Off Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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• Malfunction of the exhalation valve. • Excessive leakage. Setting range On, Off Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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High Inspired Tidal Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Exhalation valve circuit or if MPV breath mode is used.
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Expired Tidal Vol- ume exceeds the set limit for the High Expired Tidal Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Leakage circuit. Priority...
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Low Inspired Tidal Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Exhalation valve circuit or if MPV breath mode is used.
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Expired Tidal Volume fails to reach the set limit for the Low Expired Tidal Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Leakage circuit. Priority...
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High Inspired Minute Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Exhalation valve circuit or if MPV breath mode is used.
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High Expired Minute Volume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Leakage circuit. Priority...
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Low Minute Vol- ume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Exhalation valve circuit or if MPV breath mode is used.
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Low Minute Vol- ume alarm for 15 ±0.5 seconds. This alarm is only used if the Vivo 50’s patient circuit type is set to Leakage circuit. Priority...
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Setting max 70 bpm, Off Setting resolution 1 bpm Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Setting max 30 bpm Setting resolution 1 bpm Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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15 s above 15 s. In MPV breath mode: 15 s below 60 s, 60 s above 60 s. Ventilator action The Vivo 50 will continue treatment with the same settings. 128 Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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ESCRIPTION Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message. Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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• Patient circuit is disconnected. Setting range On, Off Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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A Rebreathing alarm will be given if the exhala- tion valve is obstructed for more than 10 con- secutive breaths. • Using MPV breath mode: A Rebreathing alarm will be given if air returns into the Vivo 50 for more than 10 consecutive breaths. Priority Medium Possible cause •...
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Setting min Setting max 100%, Off Setting resolution Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Off, 21% Setting max 100% Setting resolution Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message. Alarms Vivo 50 Operating manual Doc.
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Setting min Setting max 100%, Off Setting resolution Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Off, 70% Setting max 100% Setting resolution 1% Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Setting max 74 mmHg, Off Setting resolution 1 mmHg Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Setting max 74 mmHg Setting resolution 1 mmHg Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Setting max 74 mmHg, Off Setting resolution 1 mmHg Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Setting max 250 bpm, Off Setting resolution 5 bpm Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Setting max 250 bpm Setting resolution 5 bpm Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
Priority High Ventilator action The Vivo 50 stops treatment and gives alarm for at least 2 minutes and up to 10 minutes. If power is restored within 2 minutes, the Vivo 50 will automatically resume treatment with current settings.
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Possible cause • Blocked air inlets. • Blocked cooling air outlets. • Too high ambient temperature. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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15 minutes of operat- ing time left with current settings. Priority Medium Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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• Failure in the CO sensor. • Internal failure in the Vivo 50. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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• SpO Sensor disconnected. • Failure in the SpO sensor. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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High Possible cause • Bad positioning or occlusion of the probe. • Low blood flow in finger. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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• CO Sensor disconnected. • Failure in the CO sensor. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Perform a zeroing procedure of the CO sen- sor. Priority High Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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CO sensor. Check/replace the airway adapter. Priority High Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Priority High Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Sensor disconnected. • Communication with the FiO sensor failed. Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message.
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Priority Medium Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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LED indicators on the front panel is broken. Priority Medium Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED, if possible, and a display message.
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Keep the unit connected to mains until this alarm disappears. Priority Medium Ventilator action The Vivo 50 will continue treatment with the same settings. Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message.
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Internal Function Failure Alarms (Int. Function Failure) ESCRIPTION Definition An Internal Function Failure alarm will be given when the Vivo 50 has an internal func- tion failure. All Internal Function Failure alarm error codes are defined and explained in the Vivo 50 Service Manual.
The alarm test should be included in the regular maintenance inspections and controls that shall be carried out at least every 12 months. To perform the alarm test follow, the instructions below: Connect the Vivo 50 patient circuit to a test lung. Adjust the settings as follows: ETTING...
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Vivo 50. Disconnect the airway adapter from the CO sensor. 14.2 The check CO adapter alarm shall be given. 14.3 Connect the airway adapter to the CO sensor. 14.4 Alarm test completed. Alarms Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
• Do not under any circumstances attempt to service or repair the Vivo 50 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 50. EVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF...
• Never apply any liquids directly on the Vivo 50 by spraying, splashing or pouring. Use a moistened lint-free cloth when cleaning. • Do not use an excessive amount of liquid when cleaning the Vivo 50. • Do not autoclave the Vivo 50.
Cooling Air Inlet Turn off the Vivo 50 and place it on a dust free surface. Vacuum-clean the cooling air inlet once a month or when necessary. Patient Circuit The patient circuit should be cleaned and replaced in accordance with the manufac- turer’s instructions and care provider’s instructions, where applicable.
Do not wash or reuse the disposable filter. 7.3 Change of Patient If the Vivo 50 is used in a clinic by several patients, a low resistant bacte- rial filter may be used between the air outlet and the patient tube to pre- vent patient cross-contamination.
-4 to +140°F (-20 to +60°C). For instructions on how to charge the bat- teries after long time storage, see “Using Batteries” on page 91. • The Vivo 50 must not be stored in a warm place, such as direct sun- light or close to a radiator.
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Pneumatic Diagram for the Vivo 50 ESCRIPTION Air inlet with filters Inlet silencer Blower Outlet silencer Restriction Patient air outlet Flow sensor Pressure sensors Exhalation valve control pressure outlet Exhalation valve control pressure valve Exhalation valve control pressure sensor Low pressure/bleed-in oxygen connection...
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Tolerance: 1 bpm Inspiratory 0.3 to 5 s. 0.1 s Time Tolerance: ±0.1 s (PCV, VCV, PCV-SIMV, PCV-MPV, VCV-SIMV, VCV-MPV) Backup 0.3 to 5 s. 0.1 s Inspiratory Time (PSV) Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Time (PSV) Max Inspira- 0.3 to 3 s, Off. 0.1 s tion Time (PSV) Backup Rate 4 to 40 bpm. 1 bpm (PSV) Tolerance: ±10% of set value. 168 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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±0.5 cmH O below 10 cmH ±5% above 10 cmH Audible alarm 1 to 9, where 1 is the lowest level volume setting and 9 is the highest volume setting. Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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4-beat average signal processing. 10:1 to 1:99, Max ±0.1 unit below 1:10 ±1 unit above 1:10 Insp. Time 0.3 to 5 s. ±10% Rise Time 0.1 to 5 s. ±10% 170 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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High Vt 100 to 3000 ml, Off. Yellow LED, audible Alarm Resolution: 10 below alarm and a warning 500 ml, 100 above 500 ml. message on the display. Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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15 s above 15 s. In MPV breath mode: Off, 15 to 900 s Resolution: 15 s below 60 s, 60 s above 60 s. 172 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Low Pulse Rate Off, 20 to 250 bpm. Red LED, audible Alarm Resolution: 5 alarm and a warning message on the display. Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Alarm Sensor The CO2 measurement is Red LED, audible Accuracy inaccurate. alarm and a warning Unspecified message on the display. Alarm 174 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Internal Func- Various types of internal Red LED, audible tion Failure function failures. For defi- alarm and a warning Alarms nitions, refer to Vivo 50 message on the display. Service Manual. Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Pressure (cmH Ambient pressure (mbar) As seen in the graph above, the Vivo 50 is unable to deliver set max pressure at a very low ambient pressure. Humidity 10% to 95%, non-condensing 176 Technical Specifications Vivo 50 Operating manual Doc.
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290 mm with click-on battery) × × Weight 5.2 kg without click-on battery (6.7 kg with click-on battery) Patient air outlet 22 mm male, 15 mm female conical standard connector Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Filtering/Smoothing Techniques UNCTION ECHNIQUE ESCRIPTION Pressure Low pass average time constant 16 ms Inspiration trigger Differential mass flow resolution 4 ms Expiration trigger Flow low pass filtering with level sensing 178 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
8.3 Emission and Immunity Declaration According to IEC 60601-1-2(2001) + A1(2004). The performance of all functions of the Vivo 50 is considered as essential performance for the purpose of immunity testing. Guidance and Manufacturer's Declaration – Electromag- netic Immunity The Vivo 50 is intended for use in the electromagnetic environment specified below.
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UT is the mains voltage prior to application of the test level. Portable and mobile RF (radio frequency) communications equipment should not be used no closer to any part of the Vivo 50, including cables, 180 Technical Specifications Vivo 50 Operating manual...
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To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be consid- ered. If the measured field strength in the location in which the Vivo 50 is used exceeds the applicable RF compliance level above, the Vivo 50 should be observed to verify normal operation.
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Guidance and Manufacturer's Declaration – Electromag- netic Emission The Vivo 50 are intended for use in the electromagnetic environment specified below. The customer or the user of the Vivo 50 should assure that it is used in such an environment. –...
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(transmitters) and the Vivo 50 as recommended below, according to the maximum output power of the communications equipment. ATED MAXIMUM OUTPUT EPARATION DISTANCE ACCORDING TO THE POWER OF TRANSMITTER FREQUENCY OF TRANSMITTER 150 kHz 80 MHz to 800 MHz to...
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I is the maximum current rating of the con- ductor in amperes (A) according to the transmitter manufacturer; H is the Vivo 50 immunity compliance level to electromagnetic fields in the 50- 60 Hz frequency span (30 A/m).
8.4 Compliance of Standards The Vivo 50’ s ventilator system, including accessories, complies with the following standards. TANDARD PECIFICATION IEC 60601-1 Medical electrical equipment - Part 1: Gen- eral requirements for safety. IEC 60601-1-1 Medical electrical equipment - Part 1-1:...
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IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. 186 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
Medical Device Directive 93/42/EEC. Class II Classification according to US FDA regu- Regulation code: lation. 868.4500 Product code: CBK The Vivo 50 and its packaging do not contain any natural rubber latex. 8.5 Delivery Settings ODES AND UNCTIONS ETTING Ventilation mode Pressure, PCV(A)
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500 ml High Vt Alarm 500 ml Low Vt Alarm 200 ml Low Vt Alarm 200 ml High MV Alarm High MV Alarm High MV Alarm High MV Alarm 188 Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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High Pulse Rate Alarm Low Pulse Rate Alarm THERS ELIVERY Patient operating time Display light Light Intensity Alarm sound level Unit mmHg Auto keypad lock Patient circuit type Exh. Valve Pre-use Test Technical Specifications Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
Only use accessories recommended by Breas Medical AB. Breas Medical AB cannot guarantee the performance and safety for the use of other accessories with the Vivo 50. The following Breas accessories are currently available for the Vivo 50: 190 Accessories Vivo 50 Operating manual...
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Power cord 005432 Click-on battery Power source for transpor- 004559 tation Click-on battery 005189 charger External Battery 004899 cable 24 V DC Hygroscopic Con- Humidifier 003974 denser Humidifier (HCH) 192 Accessories Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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Read/write memory card 002185 reader writer Vivo 50/60 PC Data monitoring software 005100 software CD USB cable Data cable: PC and Vivo 50 004886 (USB to USB) Remote alarm with Monitor Vivo 50 alarms 10 m: cable remotely 005036 25 m:...
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004901 Protective cover Shock protection 004938 sensor Measure CO in the patient 004903 Airway adapter, Connects the CO sensor 005263 disposable to the patient circuit (25 pcs) Polishing cloth 005066 194 Accessories Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
10 Patient Settings This page can be copied and used for noting the patient’s settings. Patient Settings - Breas Vivo 50 Patient ....................Date ....................Clinic ....................Set by ....................CPAP Patient Circuit ............... Pressure ......Inspiratory Trigger ....PEEP ......
High Inspired Minute Volume ..................... 118 High Inspired Tidal Volume ..................142 High Patient Air Temperature ........................116 High PEEP ........................112 High Pressure ......................139 High Pulse Rate ........................134 High SpO2 196 Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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....................... 150 CO2 Sensor Error alarm ................147 CO2 Sensor Failure/Disconnection alarm CO2 sensor port ..........................23 position ..........................52 CO2 unit .......................... 104 CO2 zeroing ...................... 185 Compliance of standards 198 Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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..........................52 Display light ..........................162 Disposal Electrical safety ........................9 user precautions ......................58 End-tidal carbon dioxide Enter ......................... 38 operating mode Environmental conditions ......................10 safety information ........................176 specifications Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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....................... 29 First use check, Vivo Flow pattern ..........................79 setting Form ........................ 195 patient settings ......................22 Front panel, main unit ......................155 Function Failure alarm ....................22 Function/navigation buttons 200 Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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......................... 58 monitored value Inspect ..........................33 cables .......................... 33 placement ......................... 33 Vivo before use ........................ 59 Inspiratory pressure Inspiratory time ......................... 57 monitored value ..........................63 setting Inspiratory trigger Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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MVi, Minute volume, inspired ..........................54 PEEP ..........................54 Pmean ..........................54 Ppeak .......................... 57 Pulse rate ..........................58 Rise time ........................170 specifications ..........................57 SpO2 .......................... 56 Spont rate Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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..........................161 change Patient air outlet ..........................24 position ....................142 Patient air temperature alarm Patient circuit ..........................160 clean ..........................32 connect ......................12 safety information Patient circuit type 204 Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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................148 CO2 Sensor Accuracy Unspecified ......................150 CO2 Sensor Error ................147 CO2 Sensor Failure/Disconnection ..................... 151 FiO2 Failure/Disconnection ..................142 High Patient Air Temperature ....................155 Internal Function Failure Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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..........................40 navigate ..........................41 symbols User precautions ........................9 electrical safety ....................10 environmental conditions ..........................7 general ........................12 patient circuit ..........................86 definition VCV(A) ..........................86 definition VCV-MPV 210 Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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..........................86 definition Vte, tidal volume, expired ......................... 56 monitored value Vti, tidal volume, inspired ......................... 55 monitored value ..........................6 Warning, icon ..........................16 Water trap .......................... 177 Weight, Vivo Index Vivo 50 Operating manual Doc. 004970 En-Us C-2b...
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