PHILIPS Respironics OmniLab Advanced +, Clinical Manual

Page 1: ...OmniLab Advanced Clinical Manual ...

Page 2: ... 2013 Koninklijke Philips Electronics N V All rights reserved ...

Page 3: ...atures 11 2 3 Therapy Event Detection 14 Section 3 Device Setup 15 3 1 Installing the Air Filter 15 3 2 Where to Place the Device 15 3 3 Connecting the Breathing Circuit 15 3 4 Supplying Power to the Device 16 3 5 Lab Setup 17 Section 4 Viewing and Changing Settings 18 4 1 Navigating the Menu Screens 18 4 2 Using the Keypad Lock Feature 18 4 3 Accessing the Standby Screen 18 4 4 Accessing the Setu...

Page 4: ...1 Cleaning the Device 37 6 2 Cleaning and Replacing the Air Inlet Filter 37 6 3 Cleaning the Reusable Tubing 37 6 4 Cleaning for Multiple Patient Use 37 6 5 Service 38 6 6 Verifying the Pressure 38 Section 7 Accessories 39 7 1 Adding a Humidifier with or without Heated Tube 39 7 2 SD Card 39 7 3 Supplemental Oxygen 39 7 4 Nurse Call System 39 7 5 Oximeter 39 Section 8 Troubleshooting 40 Section 9 ...

Page 5: ...ord 10 SD card optional 1 2 Intended Use The OmniLab Advanced is intended to provide non invasive ventilation for pediatric patients 7 years or older 18 2 kg 40 lbs with Respiratory Insufficiency or Obstructive Sleep Apnea OSA It is also intended to treat adult patients 30 kg 66 lbs with Respiratory Insufficiency or Obstructive Sleep Apnea caused by central and or mixed apneas and periodic breathi...

Page 6: ...se indications do not occur at start up See Sections 3 and 4 for more information about device start up Bacteria Filter Philips Respironics recommends that a main line outlet bacteria filter be used whenever the device is used on multiple patients Therapy Modes Features The effectiveness of the A Flex Bi Flex C Flex C Flex or AVAPS therapy features or the autoSV mode has not been established for p...

Page 7: ...ions or decreased immunity of the device Oxygen When administering fixed flow supplemental oxygen the oxygen concentration may not be constant The inspired oxygen concentration will vary depending on the pressures patient flows and circuit leak Substantial leaks may reduce the inspired oxygen concentration to less than the expected value Appropriate patient monitoring should be used as medically i...

Page 8: ...s part of their training Condensation Condensation may damage the device If the device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Filters A properly installed undamaged gray foam filter is required for proper operation Wash periodically and replace when damaged for proper operation Extension Cor...

Page 9: ...tis media or perforated ear drum Acute or unstable cardiac failure Nocturnal or resting angina risk of infarction or arrhythmias Unstable arrhythmias Severely obtunded or heavily sedated patients At risk for aspiration of gastric contents Impaired ability to clear secretions If patients are dehydrated or volume depleted or have persistent atrial fibrillation their cardiac filling pressures may be ...

Page 10: ...nnectors and features described in the table that follows Feature Description 1 Air outlet port Connect the flexible tubing here 2 Nurse call connector Connect a nurse call or remote alarm system to the device by connecting a nurse call or remote alarm adapter cable to this connector 3 Accessory slot with cover If applicable optional accessories such as a link module or modem can be installed here...

Page 11: ...he audible portion of an alarm and it also acts as an alarm indicator See Section 5 for more information 3 Start stop button Pressing this button when the device is off causes the device to enter Standby mode Pressing this button while therapy is being delivered displays a pop up screen that allows you to either turn the device off or return to Standby mode 4 Left and right buttons These buttons a...

Page 12: ...ommunity Temperature Limitation Start Stop Caution consult accompanying documents Alarm Indicator Audio Pause Contains or presence of phthalate Nurse Call or Remote Alarm System Connector ESD Warning Symbol For Airline Use Complies with RTCA DO 160F section 21 category M Do Not Reuse 1081167 Use only with power supply 1081167 Class II Double Insulated AC Power Supply connection for the AC DC power...

Page 13: ...eed to contact Philips Respironics directly call the Philips Respironics Customer Service department at 1 724 387 4000 or 49 8152 93060 You can also use the following addresses Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany ...

Page 14: ... breaths are machine cycled This is a pressure limited machine or patient triggered time cycled mode The cycle time is determined by the Inspiratory Time setting AVAPS AE A novel Bi level therapy mode that provides an automatically adjusting EPAP Pressure Support and back up breath rate In AVAPS AE mode the device monitors the patient s upper airway resistance and automatically adjusts the deliver...

Page 15: ...ached and the target tidal volume is not achieved the Low Tidal Volume alarm activates if enabled WARNING The effectiveness of the A Flex Bi Flex C Flex C Flex or AVAPS therapy features or the autoSV mode has not been established for pediatric patients at this time AVAPS Rate The AVAPS Rate setting allows you to adjust the maximum rate at which the pressure support automatically changes to achieve...

Page 16: ...S autoSV and Auto BiLevel modes The Bi Flex attribute adjusts therapy by inserting a small amount of pressure relief during the latter stages of inspiration and during active exhalation the beginning part of exhalation Bi Flex levels of 1 2 or 3 progressively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of expiration WARNING The effectivenes...

Page 17: ...aks in the system and to automatically adjust its trigger and cycle algorithms to maintain optimum performance in the presence of leaks This feature is known as Digital Auto Trak The device continuously monitors flow and adjusts the estimate of patient flow as circuit leak changes The compensation provides a better estimate of patient flow to be used to track patient breathing patterns and calcula...

Page 18: ...s not meet criteria for an apnea or hypopnea Snoring though usually associated with this condition need not be present The RERA algorithm monitors for a sequence of breaths that exhibit both a subtle reduction in airflow and progressive flow limitation If this breath sequence is terminated by a sudden increase in airflow along with the absence of flow limitation and the event does not meet the con...

Page 19: ... must flow freely around the device for the system to work properly Make sure the device is away from any heating or cooling equipment ex forced air vents radiators or air conditioners 3 3 Connecting the Breathing Circuit You will need the following accessories in order to assemble the recommended circuit Philips Respironics interface nasal mask or full face mask with integrated exhalation port or...

Page 20: ...s pre wired and properly terminated to ensure safe connection of an external battery to the device Battery operating time depends on the characteristics of the battery and usage of the device Due to a variety of factors including battery chemistry age and use profile the capacity of the external battery as shown on the device display is only an estimate of the actual remaining capacity Refer to th...

Page 21: ...trol room 1 OmniLab Advanced device 4 Serial cable DB9 Female to Male 6 ft 2 Link module 5 CAT5 cable 3 Philips Respironics PSG 6 Control room PC Lab setups will vary If you are not using a Philips Respironics polysomnograph PSG system you will need to use the OmniLab Connect device Refer to the instructions included with the OmniLab Connect and any accessories for more detailed information ...

Page 22: ...ormally would by pressing the Up button Note There is a keypad lock inactivity time out period After you have unlocked the keypad as indicated the keypad will re lock after five minutes of inactivity The keypad automatically unlocks if an alarm or informational message occurs and remains unlocked while alarms are active 4 3 Accessing the Standby Screen 1 After you press the button the Startup scre...

Page 23: ...2 I E Ratio 1 1 0 A 1 Monitor Screen Content The Monitor screen is divided into several panels the Monitor panel Date and Time panel Patient Accessory panel if attached and the Status panel In Simple View the Monitor screen displays the following 1 Monitor Panel Therapy mode Flex or AVAPS if enabled display next to the therapy mode along with the value setting Patient breath indicator displays bel...

Page 24: ...will continue writing to the card Settings and Alarms View and change settings and alarms Options View and change device settings such as Detailed View Language etc Alarm Log View a list of the 20 most recent alarms that have occurred Event Log View a list of all events that have occurred such as device setting changes alarms etc Information View detailed information about the device such as the d...

Page 25: ...idalVolume 200 1500 ml 10 ml res AVAPS ON 200 1500 ml 50 ml res AVAPS ON 200 1500 ml 50 ml res AVAPS ON 200 1500 ml 50 ml res AVAPS ON Breath Rate n a 0 40 BPM 4 40 BPM 0 40 BPM Inspiratory Time n a 0 5 3 0 sec 0 1 sec res 0 5 3 0 sec 0 1 sec res 0 5 3 0 sec 0 1 sec res Trigger Type Auto Trak Auto Trak Sensitive Flow Trigger Auto Trak Auto Trak Sensitive Flow Trigger n a Auto Trak Auto Trak Sensit...

Page 26: ...5 cm H2 O res AVAPS Rate n a n a 0 5 5 0 cm H2 O min 0 5 res TidalVolume n a n a 200 1500 ml 50 ml res Breath Rate n a Off Auto 4 30 coerce Tinsp Auto 0 40 BPM Inspiratory Time n a 0 5 3 0 s only if Rate is 4 30 0 5 3 0 sec 0 1 s res if rate 1 40 Trigger Type Auto Trak not adjustable Auto Trak not adjustable Auto Trak Auto Trak Sensitive Flow Trigger Flow Trigger Sensitivity n a n a only if Flow T...

Page 27: ...e setting A setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief Select Off to disable the setting AVAPS Select On or Off to enable or disable AVAPS CPAP Increase or decrease the CPAP pressure setting from 4 to 20 cm H2 O in increments of 0 5 IPAP Increase or decrease the Inspiratory Positive Airway Pressure IPAP from 4 to 30 cm H2 O in increments...

Page 28: ...increments Tidal Volume If AVAPS is enabled or in AVAPS AE mode you can adjust the target tidal volume from 200 to 1500 ml in 10 ml increments Breath Rate Use the Breath Rate setting to establish the minimum rate of mandatory breaths that the device will deliver per minute Increase or decrease the Breath Rate setting in increments of 1 Note Setting the Breath Rate to 0 turns the setting off Inspir...

Page 29: ...tem One Humidification Select On to enable or Off to disable this humidification feature System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity Note The System One Humidification option is only available if the heated tube is removed or has been disabled Humidifier Increase or decrease this setting from 0 to 5 ...

Page 30: ...o disable this alarm or increase or decrease the setting from 1 l min to 99 l min in increments of 1 High Respiratory Rate Alarm This setting enables or disables the High Respiratory Rate alarm The alarm activates when the measured respiratory rate reaches or exceeds this setting Select Off to disable this alarm or increase or decrease the setting from 1 BPM to 60 BPM in increments of 1 Changing O...

Page 31: ...ill exit the screen saver Additionally any alarm or informational message will also exit the screen saver Date Format Select either mm dd yyyy or dd mm yyyy as the date format that will display on the device screens Time Format Select either an AM PM time format hh mm AM or 24 Hour time format hh mm For example 2 49 PM or 14 49 Month The month defaults to the current month The adjustable range is ...

Page 32: ...em 2 Press the Right key to select Event Log The event log displays a list of all events that have occurred in chronological order with the most recent events displayed first 3 If desired press the Right Clear key to clear the event log Viewing Device Information 1 From the Main Menu screen use the Up Down key to highlight the Information item 2 Press the Right key to select Information The Inform...

Page 33: ...capacity Circuit Disconnect alarm is enabled 1 Heated tube is connected and Tube Temperature setting ex 1 External Battery is at 40 capacity Heart Rate The pulse rate measured in Beats Per Minute Heated tube is active and TubeTemperature setting ex 1 External Battery is at 20 capacity Oxygen Saturation The measurement of functional oxygen saturation of arterial hemoglobin SpO2 Bad heated tube stat...

Page 34: ...y alarm the Alarm Indicator Audio Pause button flashes yellow Yellow Solid Indicator When the device detects a low priority alarm a solid yellow light appears on the Alarm Indicator Audio Pause button The Alarm Indicator Audio Pause button does not light up when informational messages or confirmation alerts display Audible Indicators An audible indicator sounds whenever a power failure or a high m...

Page 35: ...e button The alarm is silenced for 60 seconds and then sounds again if the cause of the alarm has not been corrected Each time you press the Alarm Indicator Audio Pause button another 60 second period is initiated When Audio Pause is active the Alarm Indicator Audio Pause symbol appears if you are on the Monitor screen There is also a Pre silence alarm feature You can press the Alarm Indicator Aud...

Page 36: ...re within an acceptable accuracy The device continues to operate Low Circuit Leak Alarm This is a high priority alarm It occurs when the device detects that the exhalation port is partially or fully occluded High Temperature Alarm This is a high priority alarm It occurs when the device is close to reaching a high temperature limit The device continues to operate Loss of Power This occurs when a co...

Page 37: ...external battery is fully depleted 5 5 What to Do When An Alarm Occurs Complete the following steps when an alarm occurs 1 Whenever an alarm occurs first always observe the patient and ensure that adequate ventilation and oxygenation if appropriate are available 2 Look at the alarm indicators and listen to the audible Alarm Indicator Audio Pause button red or yellow and whether the LED is solid or...

Page 38: ...ears Select Right button to shut off device and silence alarm Immediately remove patient from device and connect them to alternate source of therapy Contact product support for service Pressure Regulation High Red flashing button Pressure Regulation message Operates Check for blockages or excessive leaks If alarm continues contact product support Low Circuit Leak High Red flashing button Low Circu...

Page 39: ... the keys to determine if they are lodged in the case If alarm continues place patient on alternate source of therapy and contact product support Insert SD Card When Oximeter is Attached Low Solid yellow button Insert SD Card message Operates Insert an SD card into the device or remove the oximeter Informational Messages Message Priority Audible Visual Indicators Device Action User Action Card Err...

Page 40: ...connect Alarm setting to 15 seconds 3 Exit to the Monitor Pressure screen Remove the closed end cap Verify that the Patient Disconnect alarm occurs in approximately 15 seconds 4 Press the Alarm Silence Indicator button to silence the alarm and wait for one minute until the alarm sounds again 5 Press the wheel to clear the alarm 6 Replace the closed end cap 7 Set the Patient Disconnect alarm to Off...

Page 41: ...o air dry completely before reinstalling it If the foam filter is torn or damaged replace it Only Philips Respironics supplied filters should be used as replacement filters 6 If the white ultra fine filter is dirty or torn replace it 7 Reinstall the filters inserting the white ultra fine filter first if applicable 6 3 Cleaning the Reusable Tubing 1 Clean the tubing daily 2 Disconnect the flexible ...

Page 42: ...o verify the pressure complete the following steps 1 Install the foam filter into the back of the device 2 With the device unplugged connect the system as illustrated in the diagram 3 Turn the manometer on If it does not display a reading of zero adjust the manometer to calibrate it If the manometer has variable settings for devices set it to cm H2 O 4 Supply power to the device then place the dev...

Page 43: ...Event Log to the SD card 1 Access the Setup screen in Full Menu Access mode 2 Select the Write Event Log to SD Card option from the main menu While writing is in progress a confirmation box with the message Writing in Progress appears When writing is complete a confirmation box with the message Writing Successful appears If the write could not happen a confirmation box with the message Writing Fai...

Page 44: ...support Why isn t the airflow turning on Make sure the device is powered correctly Verify that you are not in Standby mode The airflow remains off while in Standby Press the Therapy button to ensure that therapy is on If problem persists contact product support for assistance Why is the airflow much warmer than usual The air filters may be dirty Clean or replace the air filters The temperature of ...

Page 45: ...ntial Performance Collateral standard General Requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 11 Medical Electrical Equipment Part 1 11 General Requirements for Basic Safety and Essential Performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcar...

Page 46: ...t with or without the integrated heated humidifier no patient flow Displayed Parameter Accuracy Parameter Accuracy Resolution Range Estimated Leak Rate N A 0 1 LPM 0 to 175 LPM Exhaled TidalVolume Greater of 20 ml or 20 of reading 1 ml 0 to 2000 ml Respiratory Rate Greater of 1 BPM or 10 of reading 1 BPM 0 to 60 BPM Exhaled MinuteVentilation Calculation based on Exhaled Tidal Volume and Respirator...

Page 47: ... Patient Flow LPM Expiratory Resistance cm H2 O Inspiratory Resistance cm H2 O 30 1 7 1 9 60 4 9 5 5 Expected Service Life Device including power cord and power supply 5 years Flexible Tubing 22 mm 6 months Reusable Gray Foam Filter 6 months Ultra Fine Filter 1 month Disposal Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Dispose of this device in accordanc...

Page 48: ...act 8 kV Air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC 61000 4 4 2 kV for Power Supply Lines 1 kV for Input Output Lines 2 kV for Power Supply Lines 1 kV for Input Output Lines Mains power quality should be that of a typical hospital environment Surge IEC 61000 4 5 1 k...

Page 49: ...s determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structu...

Page 50: ...rding to Frequency of Transmitter meters 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 0 35 800 MHz to 2 5 GHz d 0 7 0 01 0 12 0 04 0 07 0 1 0 38 0 11 0 22 1 1 20 0 35 0 70 10 3 80 1 11 2 21 100 12 00 3 50 7 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the tran...

Page 51: ...c products and Respironics Inc reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics Inc or authorized distributors Respironics Inc disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or limit...

Page 52: ...1111036 1111019 R00 JR 8 22 2013 EN INTL ...