310 Respironics Vision BiPAP 310 / Page 1 of 15

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1 310 Respironics Vision BiPAP 310 / Page 1 of 15 Description BiPAP therapy is only appropriate in the ED, Critical Care and Transitional Care Units. The decision to administer BiPAP in any other general care area must be approved by the RCS Medical Director NOTE: The BiPAP device is not designed for continuous long term mechanical ventilation and, should not be used on intubated or trached patients that are totally ventilator dependent. Use of BiPAP is appropriate for intermittent ventilatory assistance in patients that are capable of spontaneous ventilation. Indications The use of BiPAP ventilatory support is indicated for the treatment of: 1. Sleep disorders associated with nocturnal breathing events, such as; a. obstructive apnea b. central apnea c. hypopnea d. non-apneic desaturations 2. Non-invasive ventilatory support for patients with chronic respiratory failure secondary to: a. neuromuscular disease b. restrictive lung diseases c. chronic obstructive lung disease 3. Patients who would otherwise receive Mask CPAP treatments for; a. atelectasis b. lobar lung collapse c. hypoxic respiratory failure secondary to: i. ARDS ii. pulmonary edema, iii. pulmonary contusion

2 310 Respironics Vision BiPAP 310 / Page 2 of 15 iv. flail chest injuries. 4. Intermittent ventilatory assistance Contraindications The following conditions may contraindicate the use of BiPAP therapy: head or facial trauma basilar skull fracture sinus fractures facial lacerations or fractures CSF leak tracheal or bronchial fractures untreated pneumothorax hypotension bullous lung disease sinus or middle ear infections cardiac arrhythmias or coronary artery disease CVA seizures Physician's Order The administration of BiPAP therapy (face mask pressure support) must be approved by a physician. A written order must be present in the patients chart before therapy is instituted. The order must state the IPAP and EPAP level used, the mode of operation, the frequency and duration of treatments, and acceptable pulse oximetry saturation. BIPAP via Vision Ventilator The BiPAP Vision ventilator is a microprocessor controlled positive pressure ventilatory assist system. The Vision system incorporates a user interface with multifunction keys, real time graphic displays and integral patient and system alarms. This system operates in the Continuous Positive Airway Pressure (CPAP) and Pressure Support, Spontaneous Timed (S/T) modes. Pressure regulation is achieved by monitoring proximal airway

3 310 Respironics Vision BiPAP 310 / Page 3 of 15 pressure and adjusting flows accordingly to ensure that the set pressure equals the proximal pressure. The Vision ventilator is an assist ventilator intended to augment ventilation of a spontaneously breathing patient. It is not intended to provide the total ventilatory requirements of the patient. The Vision requires an intentional leak port instead of an actively controlled exhalation valve to remove exhaled gases from circuit. The pressurized air from the Vision causes a continuous flow of air to exhaust from the leak port, flushing exhaled gas from the circuit. The Respironics mask or the Respironics exhalation valve which include an intentional leak port are required to decrease the chance for CO 2 rebreathing. Principles of Operation Oxygen Module regulates and proportions O 2 into the air from the blower according to the oxygen concentrator level set on the parameters screen. O 2 range from.21%-100%. The higher the oxygen concentration settings, the higher the oxygen flow rates required from the oxygen module and the lower the air flow rate from the blower. It is no longer necessary to bleed in O 2 from an external source to the patients circuit. However, if there is no access to a 50 psi source, O 2 can be bled into the circuit using oxygen connection tubing connected to an oxygen flowmeter and a pressure line adapter connected at the patient interface port. The Vision is intended for adult patients (>30kg) Standby Mode Activated by pressing the Standby key on the monitoring screen, this decreases the output flow to an idle state. Standby flashes in the middle of the screen. At this time parameter changes can be made and will be effective when you exit Standby mode. As a safety feature, the Standby mode is automatically deactivated if the Vision senses the patient triggering spontaneous breaths. Flow Measurement Accuracy and responsiveness of the Vision is maintained by continuous analysis of the delivered flow. The flow measured at the Air Flow Module (AFM) is analyzed to derive a signal proportional to the Total Flow Rate in the patient circuit. This signal contains a component derived from the flow delivered to the patient (Estimated Patient Flow Rate) as well as a component derived from circuit leaks (Estimated Leak Flow Rate) Circuit leaks consist of the intentional leak through the exhalation port as well as the unintentional leaks possibly found in the circuit or a poor seal of the mask around the patients face.

4 310 Respironics Vision BiPAP 310 / Page 4 of 15 BiPAP Auto-Trak Sensitivity The Vision is able to recognize & compensate for unintentional leaks in the system (w/in reason) and to automatically adjust its trigger and cycle algorithms to maintain pressures and flows in the presence of leaks. (this feature is called, Auto-Trak Sensitivity)

5 310 Respironics Vision BiPAP 310 / Page 5 of 15 Leak Tolerance Leak Tolerance is the Vision s ability to respond to changes in leaks via two adjustments: 1. Expiratory Flow Rate Adjustment At end expiration the total flow in the patient circuit should equal the baseline leak which consists of intentional (exhalation port) and unintentional (mask, mouth) leaks. Once the unit has been in EPAP for 5 seconds, the total flow is compared to the originally established value of flow leak. At this point, the Vision flow sensing circuit makes the assumption that the patients flow is zero, so that the total circuit flow should be equal to flow leak 2. Tidal Volume Adjustment Inspiratory Vt and Expiratory Vt are determined by the estimated patient flow and compared on a breath-by-breath basis. If the measured volumes during inspiration differ from expiration, the difference in volume is assumed to be due to an unintentional circuit leak. The baseline flow leak is adjusted in the appropriate direction to reduce the difference in VTi Vte on the next breath. This prevents abrupt changes in sensitivity based on random changes in the breathing pattern and allows the baseline flow leak to accommodate to the new breathing pattern. Sensitivity While operating in the S/T mode the Vision senses spontaneous breathing efforts causing the ventilator to trigger IPAP and cycle EPAP. The Vision continuously tracks patients breathing patterns and automatically adjusts sensitivity thresholds to ensure optimum sensitivity as breathing patterns change or as circuit leaks change. The algorithms used to ensure optimal sensitivity are the Volume Trigger, Shape Signal, and the Spontaneous Expiratory Threshold (SET). See Respironics Operators Manual for more detailed description Alarms Check Ventilator Alarm Alerts clinician of potential abnormal operation by illuminating the yellow eye icon on display panel along w/an audible alarm. This can be silenced w/alarm Silence Key. The visual eye cannot be reset and will stay illuminated until error is corrected. The vent continues to operate but should be removed from patient for service as soon as possible. Ventilator Inop Ventilator Inoperative Alarm indicates a machine malfunction by illuminating the red wrench icon and activating an audible alarm. The ventilator will immediately power down, opening internal valves allowing patient to breath ambient air drawn in through the vent. Audible/Visual alarms cannot be silenced until power is turned off.

6 310 Respironics Vision BiPAP 310 / Page 6 of 15 Exhalation Port Alarm Intended to identify an occlusion or leak at the exhalation port. Front Panel Hard - Soft Key Controls The Vision has 8 hard keys and 10 soft keys to control the ventilator, graphics and alarms. Hard Keys: Soft Keys -Monitoring -Scale The function of the soft key changes w/the -Parameters -Freeze/Unfreeze displayed screen -Mode -Alarms -Alarm Reset -Alarm Silence Note: Alarm Silence Turns off audible alarm for 2 minutes. If a new alarm condition occurs during this silent moment, a visual alert will appear in Mode/Message Area Front Panel Ports Patient Interface Port - Place Bacteria Filter on this port Pressure Line Port - Proximal Pressure Line from the patient circuit to monitor patient pressure Front Panel Knobs Adjustment Knob - Rotary knob that changes the value of a parameter that is selected w/a soft key. Active only when a soft key selection has been made. To increase the value of a selected parameter, turn the knob counterclockwise. The knob has detents, each of which corresponds to one increment of the parameter value. (see diagram below)

7 310 Respironics Vision BiPAP 310 / Page 7 of 15 Screens Power On: Exhalation Port Test After Self Test is completed, the Start-up screen allows clinician to perform the Exhalation Port Test which analyzes the leak rate of the exhalation port. During the test the system measures the intentional exhalation port leak over the complete pressure range. Remove mask from complete circuit, occlude end of exhalation valve and perform test. This value is stored in memory and used to perform leak calculations and provide an accurate display of patient leak and Vt in Data Display area. (If the Exhalation Port Test is NOT performed, the VT and Minute Ventilation will be inaccurate. Subsequently, inaccurate Ve measurements could alter accuracy of low Ve Alarm Reviewed 11/10 Revised 7/96, 8/98, 02/02, 08/04, 10/07, 1/08, 8/08, 6/12

8 310 Respironics Vision BiPAP 310 / Page 8 of 15 Monitoring Screen Displays current mode, graphic displays of pressure, volume and flow, numerical values for calculated and measured parameters and Oxygen concentration. Parameters Screen Allows clinician to adjust parameters for the current mode. Displays same graphs and numerical values as monitoring screen. Change Mode Screen Allows clinician to view or change mode which also permits RT to adjust parameters for the new mode before changing the mode. Alarms screen Allows clinician to change alarm limits for active mode. Set Up and Starting Vision Assemble Circuit Bacteria filter Humidifier Chamber (Insure Humidifier is in Non-Invasive mode) H 2 O bag Heated wire circuit Temp sensor 02 tubing for pressure line Respironic s Exhalation Valve Mask: anesthesia mask or appropriate size nasal mask. Humidification is required if you anticipate patient will require long term therapy or Bipap for a trached patient.

9 310 Respironics Vision BiPAP 310 / Page 9 of 15 CPAP MODE Active CPAP controls are CPAP %O 2 The monitoring screen displays CPAP and total respiratory rate, Estimated Exhaled Vt, Estimated Ve, PIP, Ti/Tot, Leak (patient or total) Alarms are activated once CPAP is started. Adjusting CPAP: Press the CPAP soft key & turn adjustment knob to desired level. Set High Pressure Alarm above CPAP level. Range-5 to 50 cmh20 Set Low Pressure Alarm below CPAP level. Range- Disabled to 40cmH20. Low Pressure Alarm Delay. Range 0-60 seconds Apnea. Range Disabled to 20 to 40 seconds. *Learn Base Flow (This is necessary in all modes.) Whenever you introduce extra flow into patient circuit (i.e. 02 flow for nebulizer treatments), this may alter baseline flow and trigger Exhalation Port Alarm. Turn flowmeter on w/o 2 tubing adapted into patient circuit. Push Learn Base Flow soft key. This will take 2 minutes and will not affect Bipap operation. You do not have to activate Learn Base Flow again after flow from treatment is removed.

10 310 Respironics Vision BiPAP 310 / Page 10 of 15 Reviewed 11/10 Revised 7/96, 8/98, 02/02, 08/04, 10/07, 1/08, 8/08, 6/12

11 310 Respironics Vision BiPAP 310 / Page 11 of 15 Active S/T controls: IPAP 4-40 cm H 2 O Timed Inspiration sec EPAP 4-20 cm H 2 O IPAP Rise Time 0.5, 0.1, 0.2, and 0.4 seconds Rate 4-40 BPM %O 2.21-%100. All other monitoring is as mentioned in CPAP mode. Changing to the S/T Mode 1. If pt is currently in CPAP mode, press MODE hard key 2. Change mode screen is displayed, S/T is displayed in right column 3. Press S/T soft key. 4. The New Mode/Set-up Parameters screen for the S/T Mode is displayed 5. Select adjustments: IPAP, EPAP, Rate, Timed Inspiration, IPAP rise time 6. Activate New Mode will flash on screen until you press Activate new mode soft key 7. Press soft key that corresponds to the parameter you want to set. 8. Turn adjustment knob to desired level for that parameter. 9. Once S/T Mode is in operation, press the ALARMS hard key to view S/T alarms settings.

12 310 Respironics Vision BiPAP 310 / Page 12 of 15 All other Alarms will be set as mentioned in CPAP mode except for Low Pressure Alarm. The Low Pressure Alarm should be set below the IPAP and above EPAP. For modification of graphic displays, changing time, date etc. see manual.

13 310 Respironics Vision BiPAP 310 / Page 13 of 15 See diagram below for complete circuit. Patient Assessment / Reassessment The patient s response to therapy should be assessed and reassessed. Patient assessment and reassessment should be performed according to the general RCS policy (see Section IV - Patient Assessment / Reassessment in the RCS Policy Manual). The need to continue therapy should be reassessed every 24 hours. Specific criteria for assessment and reassessment should include: Changes in sleep disordered breathing Changes in work of breathing Changes in lung expansion Patient s tolerance to therapy Development of any complications listed in the next section Reviewed 11/10 Revised 7/96, 8/98, 02/02, 08/04, 10/07, 1/08, 8/08, 6/12

14 310 Respironics Vision BiPAP 310 / Page 14 of 15 Complications Pneumocephalus has been reported in patients receiving mask CPAP. Patients with a history of head or facial trauma should be carefully evaluated prior to instituting BiPAP therapy. Patients must be ruled out for basilar skull fractures; sinus and facial fractures; and CSF leaks. The presence of any of these conditions is a direct contraindication for the use of nasal or face mask BiPAP therapy. Barotrauma. Pneumothorax, pneumomediastinum, and subcutaneous emphysema are potential complications that may result from BiPAP therapy. If the development of any of these conditions is suspected, discontinue BiPAP therapy and notify the ICU resident. Hypotension. Cardiovascular compromise as a result of positive pressure ventilation is a potential complication that may be associated with BiPAP therapy. If a patient develops hypotension secondary to BiPAP, discontinue therapy and notify the ICU resident. Aspiration is a potential complication especially when administering BiPAP via full face mask. Nausea and gastric distension secondary to aerophagia may be the precipitating factors. Placement of a nasogastric tube may be necessary. If a patient vomits, immediately discontinue therapy, clear the airway, and notify the ICU resident. Pressure Necrosis and Dermatitis. Patients receiving continuous BiPAP therapy by nasal mask or full face mask must be monitored for the development of pressure sores or dermatitis. Patients must be checked for skin reactions secondary to mask pressure at least every four hours. If a patient develops an adverse skin reaction, discontinue therapy and notify the ICU resident and nurse. Patient Accommodation. Patient comfort and cooperation are important considerations for the successful use of BiPAP. To improve patient accommodation the procedure should be thoroughly explained to the patient when possible. If the patient shows signs of poor accommodation (decreased S p O 2, increased RR, increased P a CO 2 ), discontinue therapy and notify primary physician caring for the patient. Charting Charting entries must be made in the CareVue system or on the patient's cardiopulmonary flowsheet for every BiPAP treatment given, or at least every four hours if BiPAP is administered continuously. Charted parameters should include BiPAP for the mode, F I O 2, IPAP level (PIP), EPAP level (EEP), breaths per minute, set breaths per minute (Timed Modes only), estimated tidal volume, and pulse oximetry values. If the patient is receiving intermittent BiPAP treatments, the duration of each treatment should be indicated (eg. x15 min).

15 310 Respironics Vision BiPAP 310 / Page 15 of 15 Charges Charge for BiPAP Setup for the initial set up, and BiPAP Daily for every day of continuous use. Charge for BiPAP Circuit Change every time you change the circuit. Hyperinflation TX should be charged for each intermittent BiPAP treatment used to reverse atelectasis Discontinuation BiPAP should be discontinued per physician's order. The BiPAP unit is to be disinfected with germicidal wipes. If the black rubber mask strap were used, place in the RCS dirty equipment bin in the 4E utility room. SPD will sterilize. Dispose of all single patient use equipment in the appropriate trash container.

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