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Vivo 40 must only be used

1. SO CO NI DI GA By CG NH res E E Bo Technical Specifications 89 Doc 003886 En Us A te Vivo 40 clinician s manual 90 12 2 Data SETTING VALUE RANGE PERFORMANCE RESOLUTION Ventilation modes PSV Pressure Support Ventilation e PCV Pressure Control Ventilation CPAP Continuous Posi tive Airway Pressure Target Volume Active nactive Device modes Clinical Home EPAP 2 cmH5O to 20 cmH5O or IPAP IPAPmin 2 cmH O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH O 1 0 above 10 cmH O IPAP 4 to 40 cmH O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH O 1 0 above 10 cmH O IPAPmin Target Volume 4 to 40 cmH5O or to IPAP max Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH5O 1 0 above 10 cmH O Target Volume 0 2 t0 1 51 0 05 IPAPmax Tar get Volume Technical Specifications Vivo 40 clinician s manual 4 or IPAPmin to 40 cmH O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH O 1 0 above 10 cmH O Doc 003886 En Us A 1e SETTING VALUE RANGE PERFORMANCE RESOLUTION CPAP 4 to 20 cmH 0O 0 5 below 10 cmH O Tolerance 2 of the maxi 1 0 above 10 cmH O mum value and 10 of the set value Breath rate 4 to 40 bre
2. IPAPmin PSV amp PCV only Target Volume active Setting range 4 to 40 cmH O or to IPAPmax Navigate to the section Setup EPAP PSV amp PCV only mandatory 2 cmH5O to IPAP IPAPmin Setting 20 cmH5O 2 cnH5O Navigate to the section Setup Doc 003886 En Us A 1e PEP 40 cmH20 Fr q r gl 8 c min Temps insp 25 Ss Temps mont e 3 uu D cl insp B fe Volume cible 1 00 PIP Max 20 0 cmH20 Appuyer R gl pour r gl simple 0 15 30 40 1 immi 15 Est Tidal Vol 0 12 Total Rate 8 bpm Leakage 18 l min IPAPmin 14 0 cmH20 EPAP 4 0 cmH2O Set Rate 8 bpm Inspiration Time 2 5 s Rise Time 3 L Inspiration Trig 6 Target Volume 1 00 IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Mode Alarm Others Setting Up the Vivo 40 Vivo 40 clinician s manual 61 Breath Rate PSV amp PCV only mandatory Setting range 4 to 40 BPM Navigate to the section Setup Inspiration Time PCV only mandatory Setting range 0 3 to 5 seconds Navigate to the section Setup and press Setup one more time to reach the More Settings page Rise Time PSV amp PCV only mandatory Setting range 1 to 9 Navigate to the section Setup and press Setup one more time to reach the More Settings page In PSV mode Rise Time is limited by Min Inspiration Time 0 10 20 30 40 Um c 17 Cl st Tidal Vol 0 221 Total Rate 8 bpm Le
3. The Others Menu The menu list for Others in standby 29 9 5 5 9 mode with HA 01 humidifier con VENTILATOR OFE nected Ramp Wake Up Alarm Device Settings Device Information Memory Card Time and Date Press rand to select Menu Mode SetUp Alarm The menu list for Others in operat h mT ts ON Est Tidal Vol 0 07 ing mode oe eo Leakage 26 Vmin Humidity Ramp Wake Up Alarm Device Settings Device Information Press Nand to select Menu Mode SetUp Alarm Wake up Alarm Navigate to the section Others and mgt 3 select Wake up Alarm to reach the fana gi e ec 29 Wake up Alarm Wake up Alarm page P Wake up Time 07 30 Sound Intensity 1 Return to other Menu Mode Set Alarm Device Settings Navigate to the section Others and select Device Settings to reach the mr 8 bm a T Device Settings Device Settings page a IE Light Intensity 5 Display Contrast 5 Pressure unit cmH20 Return to other Menu Mode Set Alarm 40 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e Device Information Navigate to the section Others and select Device Information to reach the Device Information page Time and Date Navigate to the section Others and select Time and Date to reach the Time and Date page Switching between Clinical and Home Mode 1 Navigate t
4. 1 1 2004 13 29 1 1 2004 13 29 1 1 2004 13 27 1 122004 13 27 1 1 2004 13 13 1 1 2004 13 12 Main Others Humidit Ram OX 5 5 Transferring Data between the Vivo 40 and a PC conditions are fulfilled and considered A Read the chapter Electrical Safety on page 10 carefully to make sure all In order to view and present patient data correctly the Breas Vivo PC Software must be installed on the PC n Instructions on bow to manage data in the Breas Vivo PC Software can be found in the software help Data can be transferred in three ways Memory card iCom communication unit Vivo PC data cable Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e Memory Card i The Vivo 40 can only copy and transfer data to the memory card in standby mode not operating The memory card is used for copying and transferring settings detail logs usage logs and breath logs 1 Insert the memory card in the memory card slot on the side of the A Vivo 40 Make sure the memory card D is propetly inserted 2 In clinical mode navigate to the Memory Card page under the VENTILATOR OFF Others section Memory Card Save log and settings on car In home mode navigate to the edt on cd Memory card page under the Bos 1o Gies Others section kir Sai i EENE 3 Select the desired operation and wait while the venti
5. 4 Check that the air filters ate installed Doc 003886 En Us A 1e Preparing the Vivo 40 for Use Vivo 40 clinician s manual 53 6 2 Placing the Vivo 40 WN Read the chapter Environmental Conditions on page 11 carefully to make sure all conditions are fulfilled and considered 1 Place the Vivo 40 on a solid flat surface facing towards the patient The Vivo 40 should be placed lower than the patient in order to prevent the device from falling on the patient as well as preventing conden sated water to reach the patient 2 Make sure that nothing can block the patient air inlet at the rear of the Vivo 40 Connecting the Vivo 40 to the AC Power Source Read the chapter Electrical Safety on page 10 carefully to make sure all conditions are fulfilled and considered To connect the Vivo 40 to the AC Power Source 1 Plug the power cord into the power inlet of the Vivo 40 2 Create a small loop on the A cable in order to prevent stretching Secure the power cotd using the cable holder 54 Preparing the Vivo 40 for Use Vivo 40 clinician s manual Doc 003886 En Us A 1e 3 Connect the power cotd to the AC power soutce Preparing the Vivo 40 for Use 55 Doc 003886 En Us A te Vivo 40 clinician s manual 6 4 Connecting the Patient Circuit P Read the chapter Usage of Patient Circuit on page 12 carefully to make sure all conditions are fulfilled and consid
6. of actual reading Estimated tidal liter BTPS Body Tempera 20 or 20 ml which volume ture and Pressure Saturated ever is the greatest Leakage liter min BTPS 1 liter min 20 Total rate BPM Breath Per Minute 1 LEE 1 10 to 10 1 0 1 unit 1 unit ALARM SPECIFICATION INDICATION Auditory alarm 45 to 85 dB A 5 dB A signal pressure Measured at 1 m Low pressure 2 cmH5O to IPAP IPAPmin Red LED audible alarm alarm resolution 1 cmH O and a warning message 92 Technical Specifications Vivo 40 clinician s manual on the display Doc 003886 En Us A 1e ALARM SPECIFICATION INDICATION High pressure Self adjusting Red LED audible alarm alarm and a warning message on the display Low volume 0 03 l to 2 01 Red LED audible alarm alarm resolution 0 05 and a warning message on the display Accuracy 0 051 Low breath rate 4 BPM to 50 BPM Yellow LED audible alarm resolution 1 BPM alarm and a warning mes sage on the display High breath rate 10 BPM to 60 BPM Off Yellow LED audible alarm resolution 1 BPM alarm and a warning mes sage on the display Low leakage Self adjusting Yellow LED audible alarm alarm and a warning mes sage on the display High leakage Self adjusting Red LED audible alarm alarm and a warning message on the display Low Internal 16 3 V Yellow LED audible Battery Warning alarm and a warning mes sage on the display Low power AC power 65 15 V AC
7. 40 clinician s manual 5 2 Switching the Vivo 40 On and Off Switching On 1 Make sure the AC power soutce is connected and the On Off switch is switched on 2 Turn on the Vivo 40 by pressing the Start Stop button on the front panel for 2 seconds Press for 4 sec onds when using an external or inter nal battery A short sound signal is heatd Switching Off 1 Press the Start Stop button on the front panel for 2 seconds max 4 seconds 2 Release the Start Stop button when the message is shown in the 3 display window anml pE bmn Release q 5 button to turn off Mode Alarm Others 3 Turn off the Vivo 40 by pressing the Start Stop button again PCV adult Target Volume m Est Tidal Vol Total Rate 0 38 8 bpm Leakage 18 l min 10 20 Press q b button to turn off 36 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 5 3 Using the Menu Use the four navigation buttons and the up down and buttons on the front panel to navigate the Vivo 40 menu DEO S 0000 Read chapter The Vivo 405 Front Panel on page 24 for exact position of the buttons im 048 0 19 42 bpm 42 bpm 20 _ l min 21 Imin Alarm Limits Humidity Ramp Wake Up Alarm 0 21 52 bpm 20 Imin Low Pressure 3 cmH20 Low Volume 0 05 High Breath Rate Off I A Low Breath Rate 8
8. 50 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e The following are examples of the operation time with new fully charged bat teries and Vivo 40 running in PCV mode SETTING VALUES EPAP 8 IPAP 10 20 30 Breath Rate 12 15 20 Insp Time 2 0 1 5 1 5 Rise Time 3 3 1 Insp Trigger Off Off Off Delivered Tidal 0 20 0 50 0 75 Volume Total Time 4h 2h45 min 1h45 min ENVIRONMENTAL CONDITIONS Ambient temperature 68 F 20 C Altitude Sea level External Battery The Vivo 40 can be operated from a 12 V or a 24 V DC external battery Use the battery cable 12 24 V DC and check carefully that the voltage is 12 V or 24 V Check the polarity of the external battery before connecting it to the Vivo 40 With an external battery connected the Vivo 40 will automatically switch over to the external battery source if the AC power cord is removed or if the AC power supply fails The external DC level is shown under Others Device infor mation in the menu Using the Vivo 40 51 Doc 003886 En Us A 1e Vivo 40 clinician s manual 1 Connect the external DC cable to the Vivo 40 Make sure that it is fit ted correctly 2 Connect the other end of the cable to the battery source o Only use a Breas external DC cable to connect the Vivo 40 to the external battety An external battery must be disconnected when the Vivo 40 is switched off otherwise the battery can
9. 7 Target Volume Target volume is a feature that automatically adapts the IPAP to make sure that the Vivo 40 delivers the desired set tidal volume to the patient The delivered volume is calculated and compared to the set target volume on a breath by breath basis The delivered IPAP for the next breath will be increased or decreased depending on the difference between the calculated volume and the set target volume Automatic pressure adjustments will be made in between two settable limits IPAPmin and IPAPmax in order to deliver the optimal sup port to the patient Target volume can be used both in PSV and PCV mode and shall combine the comfort and leakage compensation of pressure ventilation with the advantages of volume oriented ventilation Pressure cmH O seconds 4 8 The CPAP Mode In CPAP mode the device delivers a continuous positive airway pressure during operation The flow is automatically adjusted to maintain the set CPAP level within the limitations of the devices flow compensation Functions and Parameters of the Vivo 40 33 Doc 003886 En Us A 1e Vivo 40 clinician s manual 4 9 Standby and Operating Mode Standby mode is defined as the state of the Vivo 40 when AC power is con nected and the On Off switch is on but without starting the Vivo 40 with the Start Stop button Operating mode is defined as the state of the Vivo 40 when the fan is operating and producing an air flow Enter operating mode by
10. EPAP 4 0 cmH20 e IX Set Rate 8 bpm Insp Time 25 s C Press Set Up for more settings Mode NANY Alarm Others The alatm is given audibly with a tone and visibly by the yellow alarm LED and a display message Alarms Vivo 40 clinician s manual 73 Low Leakage Alarm ITEM DESCRIPTION Definition A low leakage alarm will be given when the meas ured flow is lower than the expected leakage flow at set pressure Possible cause Incorrect patient circuit leakage e Obstructed or occluded patient circuit Setting Self adjusting Ventilator action The Vivo 40 tries to continue delivering breaths according to settings Indication eT 4 LOW LEAKAGE Est Tidal Vol Total Rate 0 26 bpm Leakage 7 e gt 0 l min 10 20 IPAP 14 0 cmH20 e EPAP 4 0 cmH20 e IX Set Rate 8 bpm 25 s Insp Time C Press Set Up for more settings Mode NAN Alarm Others The alatm is given audibly with a tone and visibly by the yellow alarm LED and a display message 74 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e High Leakage Alarm Doc 003886 En Us A 1e ITEM DESCRIPTION Definition A high leakage alarm will be given when the meas ured flow exceeds the expected leakage flow at set pressure during more than 15 seconds Possible cause Leakage in patient circuit The patient has removed the mask Setting Self adjusting Ventilator action Th
11. Home Mode To show settings in home mode Enter the main screen and press up button for 3 seconds Doc 003886 En Us A 1e Dias ra P ee as PCV adult Target Volume co Est Tidal Vol 0 24 Total Rate 8 bpm IPAP EPAP Set Rate Insp Time Mode Est Tidal Vol Total Rate Leakage IPAPmin EPAP Set Rate Rise Time IPAPmax Mode kage KE 21 l min 10 20 Press Set Up for more settings 7 7 7135 ON Inspiration Time 2 5 s Inspiration Trig 6 Target Volume 1 00 Press Set Up for Basic Setting Est Tidal Vol 008 14 0 cmH20 4 0 cmH20 8 bpm 25 s Alarm Others 8 bpm 17 Vmin 14 0 cmH20 40 cmH20 8 bpm 3 20 0 cmH20 Alarm Others Main Others Humidity Ramp IPAPmin EPAP Set Rate Inspiration Time Rise Time Inspiration Trig Target Volume IP A Pmox Total Rate 13 bpm Leakage 20 Imin 14 0 cmH20 40 cmH20 8 bpm 25 s 3 8 of 1 00 20 0 emH20 OO Main Others Hui midit Ram Using the Vivo 40 Vivo 40 clinician s manual 43 44 To show alarm history and alarm set tings in home mode Enter main screen and press down button for 3 seconds High Pressure Low Pressure Low Volume Sound Level 24 cmH20 3 cmH20 0 05 High Breath Rate Off Low Breath Rate 8 bpm 5 Low Breath Rate lLow Leakage lLow Breath Rate lLow Leakage lLow Breath Rate lLow Breath Rate
12. IPAPmax PSV amp PCV only Target Volume active Setting range 4 or IPAPmin to 40 cmH 0 Navigate to the section Setup and press Setup one more time to reach the More Settings page Doc 003886 En Us A 1e h we Py Est Tidal Vol 0 241 Total Rate 8 bpm Leakage 18 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Inspiration Time 2 5 s Rise Time 3 f L Inspiration Trig 8 Target Volume 100 I IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Mode Alarm Others Setting Up the Vivo 40 Vivo 40 clinician s manual 63 Min and Max Inspiration Time PSV only optional Setting range Off 0 3 sec min and 3 sec max Navigate to the section Setup and press Setup one more time to reach the More Settings page CPAP CPAP only mandatory Setting range 4 to 20 cmH5O Navigate to the section Setup The Ramp Function optional Ramp function On Off or Disabled where On and Off turns on and off the ramp function in operating mode With the ramp function Disabled it cannot be activated in operating mode Ramp time setting range 10 to 60 min 10 20 30 40 km 18 Est Tidal Vol 0 211 Total Rate 44 bpm Leakage 15 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Rise Time 3 FL Inspiration Trig 6 Expira Trig Min Insp Time sp Ti Max Insp Time Off Target Volume 100 IPAPmax 20 0 cmH2O Mode
13. Red LED audible alarm alarm Ext DC 12 V 10 0 0 5 V and a warning message Ext DC 24 V 20 0 0 5 V on the display Int Batt 14 0 75 V Internal function Red or yellow LED audi failure alarms POWER SUPPLIES SPECIFICATION ble alarm and a warning message on the display Doc 003886 En Us A 1e AC power supply 100 to 240 V AC tolerance 10 20 50 to 60 Hz max 140 VA Technical Specifications 93 Vivo 40 clinician s manual POWER SUPPLIES SPECIFICATION Internal battery Capacity 3 8 Ah NiMH Nickel Metal Hydride Operational time 3 hours lifetime 3 years External battery 12 24 V DC tolerance 20 15 10 5 to 15 V 20 4 to 30 V Max 120 W with Breas external battery ENVIRONMENTAL SPECIFICATION CONDITIONS Operating temperature range 41 to 100 F 5 to 38 C Storage and transport tem perature 4 to 140 F 20 to 60 C Ambient pressure range 600 to 1060 cmH5O corresponding to 4000 metres above sea level to 375 metres below sea level at normal atmospheric pres sure Humidity OPERATING CONDITIONS 10 to 95 non condensing SPECIFICATION Recommended leakage 20 to 40 liter min at 10 cmH5O Minimum leakage 12 liter min at 4 cmH O DIMENSIONS SPECIFICATIONS WxHxD 7 48 x 9 57 x 8 78 inch with rear lid Weight 8 8 lbs with rear lid Air outlet 22 mm male conical standard connector 94 Technical Specifications Vivo 40 clinicia
14. The adjustable alarm settings should be re evaluated whenever a change in settings is made on the Vivo 40 This chapter describes the alarm functions used for the Vivo 40 and how to adjust the alarm levels for each ventilation mode 8 1 Alarm Function The alarm function of the Vivo 40 consists of the alarm LEDs on the front panel an audible alarm and messages on the LCD display see The Vivo 40 s Front Panel on page 24 for an overview of the position of the LEDs and the LCD display Alarm Indication fia As soon as an alarm condition is set the Vivo 40 will alarm without delay When an alarm condition arises the alarm is indicated in three ways Color LED on the panel indicates the priority of the active alarm con dition High priority Red color flashing twice per second Medium priority Yellow color flashing every 2 seconds Alarm text in display displays the name of the active alarm condition u LOW BREATH RATE P idal Vol Total Rate 21 8 bpm Leakage l 22 l min 10 00 IPAP 14 0 cmH20 EPAP 4 0 cmH2O Set Rate 8 bpm Insp Time 25 s Press Set Up for more settings Alarm Others 66 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e Audible signals indicates the priority of the active alarm condition High priority 3 signals followed by 2 more The signal sequence is repeated after a 0 5 seconds pause Medium priority 3 signals only w
15. and a display mes sage 76 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e Low Power Alarm ITEM DESCRIPTION Definition A low power alarm will be given when the internal battery source has fallen lower than its voltage alarm limit Possible cause Discharged batteries Alarm limits Internal battery 14 0 75 V Ventilator action The Vivo 40 stops giving breaths and gives alarm for 2 minutes Indication LOW POWER Est Tidal Vol Total Rate 0 09 8 bpm Leakage IE M 25 l min 10 020 s IPAP 14 0 cmH20 s EPAP 4 0 cmH20 e IX Set Rate 8 bpm Insp Time 25 s C Press Set Up for more settings Mode NAN Alarm Others The alatm is given audibly with a tone and visibly by the red alarm LED and a display message Alarms 77 Doc 003886 En Us A 1e Vivo 40 clinician s manual Internal Function Failure Alarms ITEM DESCRIPTION Definition An internal function failure alarm will be given when the Vivo 40 has an internal function failure Ventilator action The Vivo 40 will continue or stop the treatment depending on the type and priority of the alarm Indication The alarm is given audibly with a tone and visible by a display message at least for 120 seconds Ventilator reset In order to stop the alarm the ventilator must be switched off by the On Off switch on the side panel 78 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e 9 Complete Fun
16. be discharged External Battery Operation Time The operation time is dependent on the battery condition its capacity the ambi ent air temperature and the Vivo 40 settings 5 8 Vivo 40 Operating Time The Vivo 40 records two types of operating times They can be viewed jose gi bon on the page Device Information in ia UMOR m 35 Mig d Hour the Others section ps aee Voltage AC Voltage DC 0 Volt Internal Battery Status C Return to Others Menu Mode Set Up Alarm ot Ld Total Operating Time Shows the total number of hours the Vivo 40 have been operating Patient Operating Time Shows the total number of hours a patient have been using the Vivo 40 for breathing therapy 52 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 6 Preparing the Vivo 40 for Use PN Read the chapter Safety Information on page 8 before setting up and using the Vivo 40 6 1 Installing the Vivo 40 When using the Vivo 40 for the first time follow the instructions below 1 Check that all main compo nents and ordered accessories have been delivered refer to the packing note or the invoice if available 2 Ensure that the equipment is in good condition LX Sp 3 If stored more than 1 month connect the Vivo 40 to the AC power supply and switch on the On Off switch to recharge the internal battery and the alarm battery in standby mode
17. device unexplainable or sudden pressure performance or sound changes during operation or if the delivered air from the Vivo 40 is abnormally hot or emits an odor Contact your responsible care provider for an inspection Inadequate use of device or accessories may cause loss of treatment or decreased performance The Vivo 40 therapy settings must always be based on medical supervision and must be changed by authorized clinical personnel only Blood gas measurement should be performed when changing settings or changing to another device 8 Safety Information Vivo 40 clinician s manual Doc 003886 En Us A te Doc 003886 En Us A 1e Always perform the procedure Set up the Vivo 40 Before Use on page 35 before using the Vivo 40 Only use accessories recommended by Breas Medical AB Clinical personnel must read the Clinician s manual thoroughly and under stand the Vivo 40 operation before setting up and using the machine The user must read the user manual thoroughly and understand the Vivo 40 operation before using the machine All the physiological alarms of the Vivo 40 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 Any change of settings or compo nents may require the readjustment of the alarm levels Handle the Vivo 40 with cate Make sure to place and pack the device in a way that prevents unintentional start of the
18. e You must confirm all applicable settings for each of the PSV PCV or CPAP modes that are to be used by the patient See the table matrix in the follow ing section Ifyou have changed the ventilation mode always consider the settings Favor 0231 Total Rate 8 bpm x Leakage 21 l min before pressing Confirm Alarm Limits Low Breath Rate 8 bpm Sound Level 5 Always document the set values before the patient returns home 58 Setting Up the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A te 7 1 Settings Applicable for the Different Modes S Doc 003886 En Us A 1e SETTING RANGE PCV PSV CPAP EPAP 2 cmH5O to V x 20 cmH5O or IPAP IPAPmin 2 cmH5O IPAP 4 to 40 cnH5O v v IPAPmin Target 4to40cmH Oorto Y y Volume active IPAPmax CPAP 4 to 20 cmH O S Breath rate 4 to 40 BPM Breaths v Per Minute Inspiration time 0 3 to 5 sec 4 Min inspiration time Off 0 3 to 3 sec Max inspiration time 0 3 to 3 sec Off v v Rise time 1to9 v v Insp trigger PCV 1 to 9 Off v Insp trigger PSV 1to9 v Exp trigger 13509 v Target Volume 0 2 to 1 51 Y JY IPAPmax Target 4orIPAPmin Y vo Volume active to 40 cmH O Ramp time PSV 10to 60 min v v v PCV CPAP Ramp start pressure 2 cmH O to EPAP Y vo Ramp start pressure 3 cmH5O to CPAP y HA 01 humidifier 1 to 9 Off Y v x The ventilation modes and setting parameters are described in detail in
19. interfaces must be pi certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 Ifin doubt consult the technical service department or your local representative 100 Accessories Vivo 40 clinician s manual Doc 003886 En Us A 1e
20. m 27 4 1 Ventilation Mode ete dee ee nr das ede PETERE Dee reese 27 4 2 Device MOde t Heated en EI RR 27 4 3 ed fm 27 4 4 The PCV Mode Pressure Control Ventilation eseeeeeeeesess 30 4 5 The PSV Mode Pressure Support Ventilation eeesesesseesess 31 4 6 The Difference between PCV and PSV Mode s 32 4 7 Target Volume E 33 4 8 The CPAP MOGs cfe ate eso E a ai araa Eas 33 4 9 Standby and Operating Mode eeeeeeeeeneeneeeeninnne 34 4 10 Low Leakage Detection soo ttti petuo bem tco P Emetutte butt oiitoo ttti tut dup imus 34 4 11 Hu miditier opt ornal 2 oie erstes Dente test hend dia aad eres aiani Eini painii 34 5 Using the Viv 4O mms 35 5 1 Set up the Vivo 40 Before Use esssssssseeseseeeeenenennenennnen nennen 35 5 2 Switching the Vivo 40 On and Off sss een 36 5 3 epulis em 37 5 4 M nitormg Secti N aa eset cites e obe a Pas nested ne eps LL a es 43 5 5 Transferring Data between the Vivo 40 and a PC 44 5 6 Using the HA 01 Humidifier 1r cette 48 5 7 siti Balterigs sce dnd medetur dibae E blesha titan tad tetas 49 5 8 Vivo 40 Operating Tire ht tn Certes tir dep e rh orden ora ere a 52 6 Preparing the Vivo 40 Tor USG oou est eR TP aed inerant Qecedug hada u dent Te gt bue 53 Table of Contents 1 Doc 003886 En Us A tei BREAS Vivo 40 clinician s manual 6 1 Insta
21. machine Due to the internal battery the Vivo 40 may start if the Start Stop button is pressed even without the AC power being connected Do not use the Vivo 40 while in a carry bag Attach the rear lid and place the swivel in a down position when placing the Vivo 40 in the bag If using the Vivo 40 for a short intra hospital or vehicle transportation the following cautions need to be observed Do not mount the Vivo 40 on a wheelchair or in a vehicle Make sure that the Vivo 40 stands securely in a upright position and cannot tilt or fall Do not use the Vivo 40 outdoots duting rain or snowfall If the HA 01 humidifier is attached make sure that it is not in use and that itis empty Safety Information Vivo 40 clinician s manual 9 2 2 Electrical Safety Do not operate the Vivo 40 if it has a damaged power cord or casing The Vivo 40 may not wotk propetly if any part has been dropped damaged or submerged in watet To avoid electrical shock disconnect the electrical supply to the Vivo 40 before cleaning Do not immerse the Vivo 40 into any fluids The operator shall not touch accessible contacts of connectors and the patient simultaneously When handling the HA 01 humidifier always turn off the Vivo 40 and dis connect the Vivo 40 from the AC power supply Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 609
22. the chapter Functions and Parameters of the Vivo 40 on page 27 Setting Up the Vivo 40 Vivo 40 clinician s manual 59 60 7 2 Selecting the Mode Navigate to the section Mode and then to Ventilation Mode Use the and buttons to select the desired mode Follow the on screen instructions and adjust the parameters according to the prescribed treatment 1 20 30 40 Lm 18 Est Tidal Vol 0 20 Total Rate 8 bpm Leakage 22 Vmin Ventilation Mode Patient Mode Paediatric Target Volume Inactive Device Mode PCV CPAP The ventilator always starts in the mode and with the settings that were active when it was switched off Setting Up the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 7 3 Setting the Parameters If the set values are outside the Vivo 40 s working range and cannot be achieved the lines for these settings will flash Adjust the settings so that the flashing ceases For more information about how to use the menu please read the chapter Using the Menu on page 37 Study the Overview on page 39 if a page or section cannot be found IPAP PSV amp PCV only mandatory Setting range 4 to 40 cmH O Navigate to the section Setup Total Rate 8 bpm Leakage 16 l min EPAP 40 cmH20 Set Rate 8 bpm Inspiration Time 2 5 s Rise Time 3 4 Inspiration Trig 6 Press Set Up for Basic Setting Mode Alarm Others
23. 1 humidifier is disconnected and reconnected after usage according to the instructions in the HA 01 Humidifier User manual the Vivo 40 will remember the humidity setting used 48 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 5 7 Using Batteries A battery is intended as a backup power source if the primary AC power source fails Power Source Priority 1 AC power 2 External DC 3 Internal battery When a power source fails the Vivo 40 will switch to either the internal or the external battery if installed and show a message in the display window eo NEU lowing symbols Medium fJ Low Empy X The internal battery is dis connected or malfunction ing i Using the HA 01 humidifier while operating on a battery significantly decreases the battery operation time Internal Battery The internal battery can also be used as a temporary power source for transpot tation between one stationary power source to another Due to the internal battery the Vivo 40 may start if the Start Stop button E is pressed accidentally for instance when packing the ventilator in the carry bag Make sure to place and pack the device in a way that prevents unintentional start of the machine Using the Vivo 40 49 Doc 003886 En Us A 1e Vivo 40 clinician s manual The battery level is displayed in the io monitoring section The estimated i8 internal battery capacity is only shown when the Vivo 40 is operatin
24. 50 for data processing equipment and IEC 60601 1 for medical equipment Fur thermore all configurations shall comply with the valid version of the sys tem standard IEC 60601 1 1 Therefore everyone who connects additional equipment to the signal input part or signal output part config ures a medical system is responsible that the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult the technical service department or your local represent ative t If an external battery is used always disconnect it when the Vivo 40 is switched off Otherwise there is a risk that the battery will discharge f the AC power source fails and the internal or the external battery acti vates the HA 01 humidifier will be turned off automatically It must be activated again manually if humidification during battery use is necessary Only use the data connection to connect the Vivo 40 to the iCom or a PC 10 Safety Information Vivo 40 clinician s manual Doc 003886 En Us A te 2 3 Environmental Conditions Doc 003886 En Us A 1e Do not use the Vivo 40 in any toxic environment Do not use the Vivo 40 in environments where there are explosive gases or other flammable anesthetic agents present The air flow for breathing produced by the Vivo 40 can be as much as 10 F 5 C higher than room temperature Caution should be exercised if the room temperature is greater that 95 F 35
25. Alarm Others CPAP adult am Est Tidal Vol Total Rate 0 21 8 bpm Le IE akage 24 mm 10 88 L a CPAP 5 0 cmH20 Mode Alarm Others 1 20 30 40 1 M i 18 CT st Tidal Vol 0 22 Total Rate 40 bpm a lLeakage 21 Vmin 10 Ramp Start Pressure 40 cmH20 Ramp Time 10 min Always start with ramp Off Return to Others Menu Low pressure alarm disabled Mode Set Start pressure setting range 2 cmH5O to EPAP PSV amp PCV 3 cmH5O to CPAP CPAP Always start with ramp setting range On or Off or Disabled Navigate to the section Others and select Ramp to reach the Ramp page In home mode the ramp can be activated by pressing the ramp soft key for more than 1 second 64 Setting Up the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e Doc 003886 En Us A 1e Humidifier optional Setting range 1 to 9 where 9 is the maximum humidity Off Navigate to the section Others and select Humidity to reach the Humidity page In home mode the HA 01 humidifier can be activated by pressing the humidity soft key for more than 1 second m Est Tidal Vol 0 21 Total Rate 8 bpm Leakage 13 Vmin 3 Humidity Humidifier On Humidity Level 3 Return to Others Menu Mode Set Up Alarm ot Id Setting Up the Vivo 40 Vivo 40 clinician s manual 65 8 Alarms PN
26. C If a room humidifier is used place it at least 6 feet 2 meters away from the Vivo 40 The performance of the Vivo 40 may deteriorate at ambient temperatures below 41 F 5 C and above 100 F 38 C Do not use the Vivo 40 while positioned in a warm place such as direct sunlight The device complies with the EMC requirements of standards listed in Compliance of Standards on page 95 Necessary measures should be taken in order to assure that field levels exceeding 10 V m are avoided since this may impair the safety and performance of the Vivo 40 Measures should include but not be limited to normal precautions with regard to relative humidity and conductive char acteristics of clothing in order to minimize the build up of electrostatic charges avoiding the use of radio emitting devices closer than 1 m to the Vivo 40 Examples include radio emitting devices such as cellular or cordless tele phones microwave ovens and high frequency surgery apparatus The Vivo 40 all accessories and replacement parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste The performance of the Vivo 40 and treatment of the patient may deterio tate if the operation conditions in Technical Specifications on page 89 are not fulfilled Do not use the Vivo 40 immediately after storage or trans pott outside the recommended operating conditions S
27. In case of damage replace the circuit If the parts need to be disinfected this can be done in a bath of disinfectant for instance Virkon or Gigasept Then rinse the parts well in clear water and dry them thoroughly 10 2 Cleaning and Replacing the Patient Air Filters The patient air filters are located in the filter cassette at the rear of the ventilator There are two types of fil ters washable filter and disposable fil ter Washable Filter gray Replace the washable filter at least once a year Wash the filter at least once a week 1 Wash the filter using warm water and a mild soap 2 Rinse thoroughly 3 Dry the filter by squeezing it out in a towel Do not wring the filter Cleaning the Vivo 40 and Replacement of Accessories 85 Doc 003886 En Us A te Vivo 40 clinician s manual Disposable Filter white Replace the filter at least every 4th week or more often when used in high pol lution or pollen rich environments o Do not wash or reuse the disposable filter 10 3 Change of Patient If the Vivo 40 is used in a clinic by several patients a low resistance bacteria fil ter may be used between the air outlet and the patient tube to prevent patient cross contamination However if a HA 01 humidifier is connected to the Vivo 40 do not use any bacteria filter 1 Follow the instructions in Cleaning the Vivo 40 on page 83 step 1 to 5 2 Clean the HA 01 humidifier according to the Breas HA 01 H
28. PM Patient operating time Oh Pressure unit cmH O Wake up alarm sound 1 Sound level alarm 5 Display light Delayed Light intensity 5 Display contrast 6 Wake up time 07 30 Off Humidity level 6 Technical Specifications Vivo 40 clinician s manual Doc 003886 En Us A 1e 13 Accessories 13 1 Breas Accessories List PN 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 40 The following Breas accessories ate currently available for the Vivo 40 DESCRIPTION PART No Carry bag 003519 Users manual 003819 Clinician s manual 003886 Patient tube 004465 HA 01 humidifier 003530 Rear lid 003591 Filter grey washable 003563 5 pcs Filter white disposable 003564 5 pcs Leakage Exhalation port 004426 Trach elbow 004810 Low resistance bacteria filter 303 Respirgard II 004185 Filter Power cord Vivo 003522 Memory card reader writer 002185 Memory card 003619 External DC cable 003584 iCom 004143 Vivo PC data cable RJ45 to D sub 9F 003588 Vivo iCom data cable RJ45 to D sub 15F 003574 iCom PC data cable D sub 9M to D sub 9F 003721 Accessories 99 Doc 003886 En Us A 1e Vivo 40 clinician s manual DESCRIPTION PART NO iCom PC data cable USB to USB 003722 Vivo PC Software kit 004145 Accessoty equipment connected to the analog and digital
29. Table of Contents 1 INtrOd UCHION E EET 3 1 1 What is the Vivo 40 a mee neee aeaee a Aea E a EA EEA AE E A E nennen 4 1 2 IEn E PIA ria Foo E T A Saas hee tala 4 1 3 ContraindicationS ss a aeann oieee iea ENAKE ETAk AKEE ANAIE Eak Edets iia 5 1 4 Ab tthis Manual eriet eie ATAA A aeaii 6 2 Safety Informatio eaa e a aie eieaa 8 2 1 General User Precautions tete re deo ier ee Rd pe CARERE ER one Rede 8 2 2 Ele trical Safety E 10 2 3 Environmental Conditions 2 2 coena iutptaecten ito ninbnn tne SEXT SESEU Dex aaO EUR E apes 11 24 Usage of Patient Circuit 1 i the RR tbe e ter Rant dab reias 12 2 5 Invasive USE iocos Ceteri a etica btt olea uei hats C uidi 14 2 6 Usage OPFIIeIS oec t tob Du pe RR E tet ben dete 15 2 7 H tnldification sureres teet rete it rre oet reip i pr Erud 16 2 8 Cleaning and Maintenance uu ce oce So rea eepudur fate ebteue F oe pu eeduteten adus 17 2 9 Adverse Patient Symptoms cete cet a Met e a sdee see etes 18 2 10 Usageof Oxygen eR m 19 3 Product DISTAT OI AE EEE E E mme remn rennen 20 3 1 Main Components isss e a a ea a a a Aa a aa 20 3 2 AGGOSSODIBS saaren ea dace ae By eae le eee aa 22 3 3 The Vivo 40 s Front Panel 55d ER edt eph D tan 24 3 4 The Vivo 40 s Back and Side Panels sessseeeeeeneeeee 25 3 5 Equipment Designation and Safety Label sessssseeesess 26 4 Functions and Parameters of the Vivo 40 sssssssssssseeee
30. Vivo 40 The frequency at which these checks must be performed will depend on the patient s own condition and the device used You should assess this on an individual basis in accordance with the patient s needs If the patient needs assistance to take off the patient interface the patient shall not be left alone This is to avoid the risk of re breathing of CO in case of accidental ventilator failure If the patient is using a full face mask covering mouth and nose the mask must be equipped with a safety entrainment valve 12 Safety Information Vivo 40 clinician s manual Doc 003886 En Us A te Make sure that the ventilation holes in the mask or the leakage ports are nevet blocked or obstructed These ports are used to prevent re breathing of exhaled air Re breathing of exhaled gases for longer than several min utes can in some circumstances lead to suffocation At low CPAP pressures the air flow through the ventilation holes in the mask or the leakage ports may be inadequate to clear all exhaled gases Some re breathing may occur Do not leave long lengths of ait tubing around the top of the bed It could twist around the patient s head or neck while sleeping Always follow the instructions of the mask manufacturer Safety Information 13 Doc 003886 En Us A 1e Vivo 40 clinician s manual 2 5 Invasive Use For invasive applications assure that an intentional leakage port is present in the patient circuit Ins
31. afety Information Vivo 40 clinician s manual 11 2 4 Usage of Patient Circuit Only use the Vivo 40 with a mask patient tube and leakage port recom mended by Breas Medical AB and your health care professional The Vivo 40 requires an intentional leak port instead of an actively control led exhalation valve to remove exhaled gases from the patient circuit Therefore specific masks and patient circuits using an intentional leakage are required for normal operation The pressurized air from the Vivo 40 causes a continuous flow of air to exhaust from the leak ports flushing exhaled gas from the circuit The Vivo 40 should be turned on and the intentional leak ports should be checked before application e Do not breathe in the connected patient circuit unless the Vivo 40 is turned on and operating properly Do not use patient hoses or tubes made of static or electrically conductive material Always use a new mask tube and leakage port when the Vivo 40 is to be used by a new patient Patient connected parts and filter must be replaced regularly to ensure cor rect function of the Vivo 40 All replaced parts must be disposed of accotd ing to local environmental regulations regarding the disposal of used equipment and parts Periodically check for moisture in the patient circuit When present remove the moisture Before attempting to dry the circuit disconnect it from the Vivo 40 to ensure no water will flow back into the
32. akage i7 Vmin IPAPmin 14 0 cmH20 EPAP 40 cmH20 Inspiration Time 2 5 s Rise Time 3 L Inspiration Trig 6 Target Volume 1 00 IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Mode Alarm Others caia 7 9 Uo Est Tidal Vol O17 Total Rate B bpm Leakage 18 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Rise Time 3 uw kh Inspiration Trig 6 Target Volume 1 00 IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Mode Alarm Others oo 40 20 30 40 15 07 st Tidal Vol 0 18 1 Total Rate 33 bpm Leakage 15 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Rise Time 3 Inspiration Trig 6 Expiration Trig 6 771 Min Insp Time Off Max Insp Time Off Target Volume 100 IPAPmax 20 0 cmH20 Mode EN Alarm Others Inspiratory Trigger in PSV mandatory in PCV optional Setting range 1 to 9 Off where 1 is the most sensitive Navigate to the section Setup and press Setup one more time to reach the More Settings page 62 Setting Up the Vivo 40 Vivo 40 clinician s manual UE i7 3 Est Tidal Vol 0 221 Total Rate 44 bpm Leakage 15 Vmin IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Rise Time 3 Expiration Trig 8 M Min Insp Time Off Max Insp Time Off Target Volume 100 IPAPmax 20 0 cmH2O Mode Alarm Others Doc 003886 En Us A 1e Expiratory Trigger PSV only mandatory Set
33. ate defines the minimum number of breaths the Vivo 40 will deliver If the number of spontaneous patient breaths per minute is less than this number Vivo 40 will uphold this rate In PSV mode the expiratory trigger is inactive during the non patient triggered breaths and these breaths are delivered with an I E ratio of 1 2 up to maximum inspiration time of 3 seconds In PCV mode non patient triggered breaths are delivered according to settings Rise Time PSV amp PCV only mandatory The rise time setting controls the pressure increase to the desired IPAP value A high setting will give a slow increase and therefore a shorter plateau A low set ting will give a faster increase and therefore a longer plateau Min and Max Inspiration Time PSV only optional If set the min and max inspiration time setting defines a minimum and maxi mum length of each inspiration If the min and max inspiration time are set off the leneth of each inspiration is dependent on the set expiratory trigger Inspiration Time PCV only mandatory The inspiration time setting controls the length of each inspiration Inspiratory Trigger PSV mandatory PCV optional The inspiratory trigger setting defines the patient s effort required to initiate a ventilator assisted breath When the patient starts a breath an increasing flow is created in the patient cir cuit If the patient reaches the set inspiratory trigger level the increasing flow is regist
34. aths per minute 1 BPM BPM tolerance 10 of set value Inspiration time 0 3 to 5 sec tolerance 10 0 1 sec of set value Min inspiration Off 0 3 to 3 sec 0 1 sec time Max inspiration 0 3 to 3 sec Off 0 1 sec time Rise time 1to9 1 Inspiratory trig 1 to 9 Off 1 get effort level Expiratoty trig 1 to9 where 1 is the lowest 1 get effort level effort and 9 is the highest effort setting Ramp function On Off Disabled HA 01 humidi Settings Off 1 to 9 corre 1 fier sponds to 10 to 30 mgH O I lt 100 RH Heat up time from 73 F 23 C less than 1 hour Max gas temperature at patient port 109 F 43 C Audible alarm 1 to 9 where 1 is the lowest 1 level and 9 is the highest volume setting Doc 003886 En Us A 1e Maximum flow gt 200 liter min Technical Specifications Vivo 40 clinician s manual 91 SETTING VALUE Maximum lim ited pressure during single fault condition RANGE PERFORMANCE PCV PSV 60 cmH O CPAP 30 cmH O RESOLUTION Maximum steady Set IPAP 10 cmH 0 toler limiting pressure ance 10 Max flow in 1 3 of max press 110 liter CPAP mode min 2 3 of max press 150 liter min Max pressure 155 liter min Breathing resist 4 cmH5O at 30 liter min ance under sin 6 cmH5O at 60 liter min gle fault Sound level at Less than 30 dB A Measured at 1 m 10 cmH5O INDICATOR SPECIFICATION RESOLUTION Pressure 0 to 40 cmH O 2 of full scale and 4
35. bpm Device Settings Sound Laval 5 Device Information PCV CPAP Patient Mode Paediatric arget Volume Inactive Device Mode Home Press Alarm for Alarm History Press Mand to select Menu Mode Set Up 0000 0000 0000 Alarm Others The navigation buttons are used to view the different sections defined above each navigation button The same navigation button can also be used to view additional information in some sections Use the up ot down button to enter the menu list During operation and when no button has been pressed for 20 seconds the menu will automatically switch to the clock in home mode and to the simple set up in clinical mode 0 241 8 bpm 15 Imin IPAPmin IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate Set Rate 8 bpm Inspiration Time 2 Inspiration Time 2 5 s Rise Time Rise Time 3 Inspiration Trig Target Volume d Target Volume 1 00 IPAPmax 20 0 cmH20 IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Press Set Up for Basic Setting Alarm Others Alarm Others The up and down buttons are used to select values in a section The plus and minus buttons are used to alter a value Using the Vivo 40 37 Doc 003886 En Us A te Vivo 40 clinician s manual 38 Symbols Used in the Menu SYMBOL DESCRIPTION UNIT a Battery level CY Alarm time active Hour Minute zn HA 01 humidifier active to 9 Off uH Ramp active Minute A Panel locked On O
36. c 003886 En Us A 1e UL Std No 60601 1 1st Ed Medical electrical equipement Part 1 General requirements for safety Technical Specifications 95 Vivo 40 clinician s manual CLASSIFICATION SPECIFICATION Class II IEC 60601 1 Class II Type BE Electrical equipment with dual isolation and body floating isolated applied part according to IEC 60601 1 Class IIb Classification according to the European Medical Device Directive 93 42 EEC E The Vivo 40 and it s packaging do not contain any natural rubber latex 96 Technical Specifications Vivo 40 clinician s manual Doc 003886 En Us A te 12 4 Delivery Settings Doc 003886 En Us A 1e MODES AND FUNCTIONS SETTING PSV On PCV Off Target Volume Inactive CPAP Off Ramp Disable Clinical On Home Off Humidifier Off Wake up Off PARAMETERS SETTING IPAP 10 cnH5O EPAP 4cmH O Target Volume 0 51 IPAPmax 10 cmH5O CPAP 10 cmH O Breath rate 10 BPM Inspiration time 1 5 sec Inspiration trigger 3 Expiration trigger 3 Rise time 3 Max inspiration time Off Min inspiration time Off Ramp time 10 min CPAP ramp start pressure 4 cnH5O IPAP ramp start pressure 4 cnH5O Technical Specifications 97 Vivo 40 clinician s manual 98 ALARMS SETTING Low pressure 2 cmH O High breath rate Off Low breath rate 8 Low volume 0 25 OTHERS SETTING Time format 12h AM
37. ction Check This chapter describes the complete function check of the Vivo 40 This func tion check should be performed after changing the ventilation mode or if the ventilator function needs to be checked for any other reason For information on the short function check which should be performed once a day see Set up the Vivo 40 Before Use on page 35 i To perform a complete function check all tasks in this chapter needs to be com pleted in the written number order 9 1 Pre use Check Inspection of the HA 01 humidifier if used 1 Remove and open HA 01 humidifier 2 Check that there is no visible damage 3 Check that the water container is clean Inspection of device e Check that there is no visible damage Check that the surface is clean e Check that the rear lid or the HA 01 humidifier if applicable is connected properly Inspection of cables e Check that they are Breas cables e Check that the cables are undamaged e Check that the cables are properly connected Inspection of placement The Vivo 40 shall be placed on solid flat surface below the patient level Make sure that nothing can block the patient air inlet at the rear Complete Function Check 79 Doc 003886 En Us A te Vivo 40 clinician s manual 9 2 Alarm Check WN If an alarm check fails do not use the Vivo 40 and contact your responsi ble service provider for an inspection of the device i Chapter Alarms on page 66 has a
38. ctions Doc 003886 En Us A 1e 4 Functions and Parameters of the Vivo 40 This chapter includes descriptions of the modes and parameters used for con trolling the ventilation of the Vivo 40 4 1 Ventilation Mode The following modes can be selected for the Vivo 40 e PCV mode Pressure Control Ventilation e PSV mode Pressure Support Ventilation e CPAP mode Continuous Positive Airway Pressure 4 2 Device Mode e Clinical Home In order to prevent the patient from changing the settings the home mode should be activated before giving the Vivo 40 to the user The home mode hides treatment settings alarm limits and other selected information The clinical mode is used by the clinician to control all mode choices settings and limits 4 3 Settings All the parameters that are used for controlling the breathing by the Vivo 40 are listed below Read the chapter Settings Applicable for the Different Modes on page 59 for information about the modes and ranges the different settings work with IPAP PSV amp PCV only mandatory The IPAP setting is used for defining the patient s airway pressure during the inspiration phase EPAP PSV amp PCV only mandatory The EPAP setting is used for controlling the patient s airway pressure during the expiration phase Functions and Parameters of the Vivo 40 27 Doc 003886 En Us A 1e Vivo 40 clinician s manual Breath Rate PSV amp PCV only mandatory The breath r
39. dance with Breas service instructions Vivo 40 shall only be repaired or modified in accordance with Breas service manuals technical bulletins and any special service instructions by service technicians authorized by Breas Medical AB Do not under any circumstances attempt to service or repair the Vivo 40 yourself If you do so the manufacturer will no longer be responsible for the performance and safety of the Vivo 40 Furthermore no warranty will be valid Safety Information Vivo 40 clinician s manual 17 2 9 Adverse Patient Symptoms t If the patient experiences discomfort or any of the following symptoms while using the Vivo 40 a physician or responsible clinician shall be contacted immediately Bloated feeling from excessive swallowing of air while awake Ait continually leaking from the mouth while sleeping Dryness of air passages ot nose Ear pain runny nose or sinus discomfort Day time sleepiness Disorientation or memory lapse Mood change ot irritability Skin sensitivity Severe headache Chest discomfort Shortness of breath The following are potential side effects of non invasive positive pressure ther apy Ear discomfort Conjunctivitis Skin abrasions due to non invasive interfaces Aero phagia gastric distension 18 Safety Information Vivo 40 clinician s manual Doc 003886 En Us A 1e 2 10 Usage of Oxygen Doc 003886 En Us A 1e The presence of oxygen can speed up combustion of inflammab
40. detailed description of the alarm functions used for the Vivo 40 Prepare the Vivo 40 for the Alarm Test 1 Connect Vivo 40 to the AC power supply and turn it on 2 Press the Start Stop button on the front panel Check that a short sound signal is heard Press the Start Stop button again to switch off the Vivo 40 3 The Vivo 40 shall be in standby mode not operating and the AC LED see The Vivo 40 s Front Panel on page 24 shall be lit 4 Adjust the ventilator settings as follows SETTING VALUE Mode PCV IPAP 14 cmH O EPAP 2 cmH O Set tate 10 BPM Inspiration time 1 5 sec Rise time 4 Inspiration trigger Off Low pressure alarm 2 cmH O Low volume alarm 0 051 High breath rate alarm Off Low breath rate alarm 4 BPM Check the Low Leakage Alarm and High Leakage Alarm 5 Connect the patient circuit to a test lung 1 5 I and a leakage connector 6 Enter operating mode by starting the treatment 7 Block the leakage port Complete Function Check Vivo 40 clinician s manual Doc 003886 En Us A 1e 8 The low leakage alarm shall occur within 60 seconds 9 Disconnect the patient circuit from the air outlet 10 The high leakage alarm shall occur within 30 seconds Check the High Pressure Alarm 11 Enter standby mode by stopping the treatment 12 Connect a patient circuit to the Vivo 40 13 Enter operating mode by starting the treatment 14 Create pressure towards the Vivo 40 by blowing ai
41. e Main section and change the Device Mode setting back to Clinical if wanted Go to clinical 0000 PN When handing out the Vivo 40 to a patient the panel should always be locked Locking and Unlocking the Panel The panel can be locked in order to prevent an accidental change of settings The panel is locked by pressing the and buttons simultaneously for 5 seconds When bd locked the Vivo 40 enters the home mode It cannot be Q switched back to clinical mode by using the menu The Vivo 40 is unlocked from the home mode by pressing the and but tons again simultaneously for 5 seconds 42 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A te 5 4 Monitoring Section The monitoring section provides a display of the current treatment data The monitoring section is located in the top of the display window Clinical Mode The monitoring section contains a bargraph to display current pressure information about max and min pres sure mode estimated tidal volume leakage internal battery status HA 01 humidifier remaining ramp time total rate and the I E ratio In some screens the information will adapt in size and amount depending on the page layout Home Mode The monitoring section contains a bargraph information about the alarm time HA 01 humidifier remaining ramp time battery status and the panel lock is shown Settings in
42. e Vivo 40 tties to continue delivering breaths according to settings Indication The alatm is given audibly with a tone and visibly by the red alarm LED and a display message Total Rate bpm 10 20 IPAP 14 0 cmH20 EPAP 4 0 cmH20 Set Rate 8 bpm Insp Time 25 s Press Set Up for more settings Alarm Others Alarms Vivo 40 clinician s manual 75 8 3 Technical Alarm Low Internal Battery Warning The low battery alarm can be triggered prematurely by a sudden increase t in flow such as an excessive leakage a large breath or a mask off event If this should happen restart the Vivo 40 on internal battery If the low bat tery alarm persists the internal battery needs to be charged ITEM DESCRIPTION Definition A low internal battery warning will be given when the internal battery is the last power source and it falls below the voltage warning limit Under nor mal circumstances the low battery alarm will be activated approximately 15 minutes before shut down Possible cause A discharged internal battery Warning limit Internal battery 16 3 V Ventilator action The Vivo 40 will continue to give breaths with the same settings Indication eT 11 8 b IE e N XG 14 0 cmH20 baz 4 0 cmH20 e IX 8 bpm Insp Time 25 s C Press Set Up for more settings Mode NANY Alarm Others The warning is given audibly with a tone and visi bly by the yellow alarm LED
43. ed below the patient and on a flat surface This is to prevent personal injury from accidental spillage or from excess water or condensation flowing down the patient tube and into the patient s mask Extra cautions should be taken for patients who are unable to guard their airways or cannot pull off the mask When using an external heated humidifier it should be located below the Vivo 40 and the patient to prevent injury from accidental spillage If the condensation in the patient circuit is excessive the use of a heated humidifier may require the installation of a water trap in the circuit The water trap prevents any condensated water in the patient circuit from run ning into the patient airways and causing personal injury t The use of an HME Heat and Moisture Exchanger artificial nose or an external humidifier may require readjustment of the Vivo 40 s low pressure alarm e Certain HME s and HCH s Hygtoscopic Condenser Humidifiers are suf ficient to provide humidification when the Vivo 40 is used invasively Check specific suppliers recommended use 16 Safety Information Vivo 40 clinician s manual Doc 003886 En Us A te 2 8 Cleaning and Maintenance Doc 003886 En Us A 1e The Vivo 40 should be cleaned and maintained in accordance with this operating manual Do not attempt to autoclave or sterilize the Vivo 40 Vivo 40 should be subjected to maintenance service and control and any applicable upgrades in accor
44. eeeeeeeeeeeseeeeeneeeeees 87 11 2 Service and Repalir oti derit Pera sees Leone tise PERO Ple qi de vide dva trea cUE 88 11 3 Stofa gE PEERS TIENE 88 11 4 Disposal p Re ere P OE PR ont be Oe be be pete ravs 88 12 Technical Specifications sne e a aE nennen nnne nnne ee nnns 89 12 1 System DescripIOIE enses dediti oou ptu a adit nnd SM EUN MC 89 12 2 Data udentiestesb e the ead Rae T RA ates boa t intestatus 90 12 3 Compliance of Standards ssssssssssssssssssssseese ene 95 12 4 Delivery Settings O aa uie esten talea ande ERO ORE Aa aliceta 97 13 ee eg 99 13 1 Breas Accessories List eeeesssssssssssesseee een 99 2 Table of Contents BREAS Vivo 40 clinician s manual Doc 003886 En Us A tei 1 Introduction WARNING Vivo 40 must only be used e For the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel In accordance with the operating conditions specified in this operating manual In original and unmodified shape and only with accessories spec ified or approved by Breas Medical AB 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 40 is operated and maintained before taking it into use to ensure correct usage maximum performance and serv iceability WARNING Do not use the Vi
45. ered Non Invasive Use 1 Connect the patient tube to the ait outlet 39D 2 Connect the other end of the patient tube to the mask and the leakage port if applicable Invasive Use 1 Connect the patient tube to the ait outlet 2 Connect the other end of the patient tube to the leakage port a hygro scopic condenser humidifier HCH and a trach elbow gt 99 wD LM p e Intentional Leakage A 56 Preparing the Vivo 40 for Use Vivo 40 clinician s manual Doc 003886 En Us A 1e The leakage from the mask or leakage exhalation port should be at least 12 liter min at 4 cmH5O to prevent re breathing of exhaled air The recom mended mask leakage is 20 to 40 liter min at 10 cmH O pressure This leakage may be achieved by integrated leakage in the mask anadjoining leakage port Preparing the Vivo 40 for Use 57 Doc 003886 En Us A te Vivo 40 clinician s manual 7 Setting Up the Vivo 40 PN Read the chapter Safety Information on page 8 before setting up and using the Vivo 40 The configuration of the Vivo 40 therapy settings must always be pre scribed by a licensed physician and carried out by an authorized health care professional This chapter describes how to set the different parameters that are used for con trolling the ventilation of the Vivo 40 Follow the Instructions below when Setting Up the Vivo 40 Adjust the settings to find the best possible breathing comfort for each patient
46. ered by the ventilator and that immediately starts an inspiration If the patient cannot trigger a breath the ventilator will deliver breaths according to the set breath rate Expiratory Trigger PSV only mandatory The expiratory setting defines the patient s effort required to terminate an inspi ration at IPAP pressure level To increase or to decrease the set patient effort requirement the expiration trigger level can be set to a number between 1 and 9 where 1 is the lowest patient effort level setting and 9 is the highest effort level 28 Functions and Parameters of the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e CPAP CPAP only mandatory The CPAP setting sets the pressure for the CPAP Continuous Positive Airway Pressure mode The Ramp Function optional The ramp function is used for increasing the EPAP and IPAP pressure during a set time the IPAP pressure starts at 2 cmH O above the ramp start pressure Ramp start pressure lt EPAP Ramp start pressure EPAP Pressure Pressure IPAP l Ramp start pressure Time Time During CPAP mode the ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time Functions and Parameters of the Vivo 40 29 Doc 003886 En Us A te Vivo 40 clinician s manual 4 4 The PCV Mode Pressure Control Ventilation In the PCV mode the ventilation is controlled by the Vivo 40 This is done by the press
47. ety Information Vivo 40 clinician s manual Doc 003886 En Us A te 2 6 Usage ofFilters Doc 003886 En Us A 1e Always use the Vivo 40 with patient air inlet filters installed Only use filters that are specified in this manual Replace or clean the filters regularly to ensure correct function of the Vivo 40 especially when changing patient Failure to replace or clean a dirty filter may cause the Vivo 40 to operate at higher temperatures than intended When operating the Vivo 40 make sure that the air inlet and filters are not obstructed or occluded If the Vivo 40 is used in a clinic by several patients a low resistance bacteria filter is recommended between the air outlet and the patient circuit to pre vent patient cross contamination Breas Medical AB recommends the usage of the Breas filter 004185 see Breas Accessories List on page 99 Reuse of mask or bacteria filter may expose patients to contagious agents The use of a high resistance bacteria filter on the output of the device may interfere with the operation of the patient disconnect function It may also interfere with the device trigger function Do not connect any filter to the HA 01 humidifier Safety Information Vivo 40 clinician s manual 15 2 7 Humidification The HA 01 humidifier is intended for non invasive use only Do not place the Vivo 40 with the HA 01 humidifier in a bag When the HA 01 humidifier is installed the Vivo 40 must be locat
48. ff Panel locked by the Breas On Off Vivo PC software x Rise time 1 to 9 f Inspiratory trigger 1 to 9 Off Z Expiratory trigger 1109 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e Overview The Vivo 40 menu has the following section layout in the clinic mode Mode Basic Setup Alarm Limits i I I More Settings Alarm History PCV PSV CPAP Y Y Y Adjust Adjust Adjust Parameters Parameters Parameters Alarm Limits Alarm Limits Alarm Limits Active Inactive Target Volume Target Volume Adjust Adjust Parameters Parameters Alarm Limits Alarm Limits L Home Others Humidity if used Ramp Wake Up Alarm Device Settings Device Information Memory Card standby only Time and Date standby only The Vivo 40 menu has the following section layout in the home mode Doc 003886 En Us A 1e Main Clinic Others Wake Up Alarm Device Settings Device Information Memory Card standby only Time and Date standby only Humidity if used i Ramp if active Using the Vivo 40 Vivo 40 clinician s manual 39
49. g 12 51 from the internal battery This display is for indication only Charging the Internal Battery Each time the Vivo 40 is connected to the AC power supply and the On Off switch is switched on standby mode the Vivo 40 will automatically start a 10 hour charging cycle of the internal battery This is indicated by a flashing battery indicator in the display This is done regardless of the internal battery charging status To recharge an empty internal battery takes about 14 hours in standby mode The charging is reduced by 50 during operation If the temperature inside the Vivo 40 is higher than 113 F 45 C which is normal during operation the charging is decreased in order to protect the battery This will result in longer battery charging time Follow the instructions below to ensure that the battery capacity of the Vivo 40 is maximized during its lifetime Exercise the battery every 3 months by discharging it completely and fully recharging it again Repeat this procedure twice Ifthe Vivo 40 is stored for more than 1 month connect it to the AC power supply to recharge the internal battery and alarm battery Replace the internal battery every 24 months after 500 charging cycles or when necessary to ensure the battery performance Internal Battery Operation Time The internal battery operation time is dependent on the battery condition its capacity the ambient air temperature and the Vivo 40 settings
50. he HA 01 humidifier or rear lid 3 Air outlet Air path out to the patient 4 Memory card slot Read and write memory card 5 HA 01 humidifier Patient air humidification 6 AC power inlet Connection for an external AC power source 7 On Off AC power on and off 8 External DC inlet External DC power source connection 9 Data connection Data cable connection iCom PC and the Vivo 40 10 Internal battery Provides power for a limited time in case of AC powet disconnect Product Description 25 Vivo 40 clinician s manual 26 3 5 Equipment Designation and Safety Label 1 2 3 4 5 6 7 8 10 11 EXPLANATION Model designation Serial number last seven alphanumeric charac ters Data connection port for iCom or PC Before using the data connection port read Transferring Data between the Vivo 40 and a PC on page 44 carefully Class II electrical equipment double insulation Body floating IEC 60601 1 Type BF Isolated Applied Part gt 30 Bg Read the clinicians manual thoroughly before connecting the Vivo 40 to the patient oo TA CE marking applies in accordance with the direc tive MDD 93 42 EEC Before using the internal battery read Using Batteries on page 49 carefully 10 amp gt Lx Read Disposal on page 88 for information about recycling and disposal 11 Product Description Vivo 40 clinician s manual Battery instru
51. hen the Vivo 40 is powered down The last set alarm settings are retrieved after power has been off Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e 8 2 Physiological Alarm Low Pressure Alarm ITEM DESCRIPTION Definition A low pressure alarm will be given when the Vivo 40 s pressure fails to reach the low pressure alarm limit for 15 seconds Possible cause Disconnection of patient circuit Setting is higher than IPAP IPAPmin Leakage from the mask or other components of the patient circuit Setting Parameter Low pressure Min Max Resolution 2 cmH5O IPAP IPAP 1 0cmH5O min Ventilator action The Vivo 40 will continue to give breaths with the same settings Indication Total Rate 8 b 025 pm I E XS l 10 15 IPAP 14 0 cmH20 EPAP 40 cmH20 e Set Rate 8 bpm Insp Time 25 s C Press Set Up for more settings Mode Sol Alarm Others The alatm is given audibly with a tone and visibly by the red alarm LED and a display message Alarms 69 Doc 003886 En Us A 1e Vivo 40 clinician s manual High Pressure Alarm ITEM DESCRIPTION Definition A high pressure alarm will be given when the Vivo 40 s pressure exceeds 10 cmH5O more than IPAP IPAPmax for 3 consecutive breaths Possible cause Only activated under exceptional conditions such as a strong cough during the ventilator s inspiration phase Setting Self adjusting Ventila
52. ith a lower frequency than the high priority alarm The signal sequence is repeated after a 6 seconds pause Function failure Same signal as the high priority alarm or a constant signal depending on the kind of function failure Audible Signal Pause and Reactivation The audible signal can be paused by S pressing the Audio Pause button If 0x the ventilator still registers the same O alarm after 60 seconds and the Audio Pause button was pressed the audible P signal will sound again Once the audible signal has been paused it can be reactivated by pressing the Audio Pause button again for 2 seconds If a new alarm condition occur duting the silence period the audible signal will be reactivated o To ensure the timely detection of any new alarm condition never leave a patient unattended while the audible signal is paused Alarm Reset An alarm will automatically be reset once the cause of the alarm has been cor rected If an alarm condition cannot be corrected discontinue use and refer the Vivo 40 for service Alarms 67 Doc 003886 En Us A 1e Vivo 40 clinician s manual 68 Alarm History Screen Alarm History will display the 6 last foe ee 15 E alarms when the alarm occurred and ume gie what type of alarm it was The latest hebmesae 320 20 alarm will be placed in top of the list oe Press Alarm for Alarm Settings Mode Set Up EN Others The Alarm History is maintained w
53. lator load or save Saving log to to the memory card Memory Card NEEENEN 1 4 Connect the memory card reader writer to the PC and insert the memory card The Breas logo should be facing down Using the Vivo 40 45 Doc 003886 En Us A 1e Vivo 40 clinician s manual Vivo PC Data Cable The Vivo PC data cable shall not be used for data transfer while the patient is connected to the Vivo 40 Only a PC that complies to the IEC 60601 1 standards can be used for copying and transferring data during treatment of a patient Never connect the Vivo 40 directly to a network port The Vivo PC data cable can copy and transfer the same data as the memory catd However the Vivo PC data cable is considerably slower than the memory card With the Vivo PC data cable real time data can also be received and sent between the Vivo 40 and a PC 1 Connect the Vivo PC data cable to the Vivo 40 Make sure it is fitted cortectly 2 Connect the other end of the Vivo PC data cable to the PC iCom Communication Unit i The iCom is an accessory which electrically isolates the Vivo 40 from a PC and other devices i e plotters printers etc A common PC which does not comply with IEC 60601 1 must comply with IEC 60950 and be placed outside the patient area i e more than 2 meters from the patient The iCom can copy and transfer the same data as the memory card and the data cable H
54. le materi als If oxygen has been prescribed connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector At a fixed flow rate of supplemental oxygen flow the inhaled oxygen con centration will vary depending on the pressure delivered patient s breath ing pattern mask selection and leak rate When oxygen is used with the Vivo 40 the oxygen flow must be turned off when the Vivo 40 is not operating Ventilate the room adequately Do not smoke in a room where oxygen is being used Naked light bulbs and other sources of ignition must be kept a minimum of 6 feet 2 meters away from the oxygen cylinder or any part of the patient circuit Do not use aerosols or solvents close to the oxygen supply even when the oxygen supply is shut off When the Vivo 40 is not in operation and the oxygen flow is left on oxy gen delivered into the patient tubing may accumulate within the machine enclosure Oxygen accumulated in the machine enclosure will create a risk of fite Supplemental oxygen may trigger the low leakage alarm prematurely Supplemental oxygen flow may not exceed 15 liter min Supplemental oxygen affects the accuracy of the volume and flow measure ments It is not recommended to use supplemental oxygen when target vol ume is active Safety Information Vivo 40 clinician s manual 19 3 Product Description 3 1 Main Components The Vivo 40 system contains the follo
55. lling the Vivo 40 ettet erheben peor a ha ce Hb icone aea 53 6 2 Placingithe ViVo cm 54 6 3 Connecting the Vivo 40 to the AC Power Source seeeesesssss 54 6 4 Connecting the Patient Circuit eene 56 7 Setting Jp the VIVO 40 1 5 eee Etre ttr eite cete cea bet EA c d eR ELA ndun 58 7 1 Settings Applicable for the Different Modes seeeeeeseesesesssss 59 7 2 Selecting the Mode be bere oe erste RR IR pU eode bt Rt b a etus 60 7 3 Setting tie Parametefs xicccdiwsfesrrrdacers auidasvadeanthuenvubyabatoncubacnna tern td du ans 61 8 AEA E E E EE E T EE RE AT 66 8 1 Alarm F nctlon ai e re aa e E HERE ERR RETE EA E E 66 8 2 Physiological ATGETY io eaaa aara Aa a ian aea bcd E aaRS 69 8 3 ASGHNIGAl egt mr ETT 76 9 Complete Function Check erissa ea a n a A aE N EN EE 79 9 1 Pre use Check cete tutscteott teer puse xem e la taie e eh i ded de ds 79 9 2 AlatmGhecok sxcoe iere eee eater better tete teile tee Tere Tener ET 80 10 Cleaning the Vivo 40 and Replacement of Accessories eeeeeeueeeusessess 83 10 1 Cleaningthe VIVO SU usitato etd ved debe utt eet datae testas eet Lente edo pas NS 83 10 2 Cleaning and Replacing the Patient Air Filters ssessseesesssssss 85 10 3 Change OF Patient Ke t 86 11 Maintenance cene ebbe e i een o sem ced eere eget er as agentes 87 11 1 Regular Maintenance Control 2 ccccceseseeececneeeeeeeeesseee
56. lue set for expiratory trigger The limit for the high pressure alarm is reached The inspiration time is longer than the limit for maximal inspiration time or when inspiration time teaches 3 seconds The set IPAP pressure is used as a target pressure If the flow is decreased to the expiratory trigger level before the set IPAP is reached the expiration starts The figure below shows how the pressure and the expiratory trigger settings control the ventilator s function in the PSV mode The following settings have been used Pressure 20 cmH O exp trigger 8 Pressure cmH 0 Pressure 20 7 4IPAP max delivered pressure setting Fd I IN l iN N _ EPAP seconds q Insp time PSV Flow l I eer Max flow l AN I ov Flow has dropped Exp Trig l I setting 4 to set Exp Trig l seconds New breath Patient is triggered l exhales I l I VJ M Functions and Parameters of the Vivo 40 31 Doc 003886 En Us A 1e Vivo 40 clinician s manual 4 6 The Difference between PCV and PSV Mode The figure below shows the previous two examples superimposed to illustrate how the PCV and PSV modes differ Pressure cmH5O seconds Ins time PCV em Hi o P iube I I I I I x EER be PILLS ET IENIINT seconds 32 Functions and Parameters of the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 4
57. m shall occur within 20 seconds 34 Adjust the low volume alarm to 0 05 1 35 The alarm shall disappear in 30 seconds Check the Switching of Power Source to the Internal Battery 36 Disconnect the power cord from the AC power supply 37 Treatment continues and the Vivo 40 runs on internal battery with the internal battery LED lit 38 Reconnect the power cord to the AC power supply 39 The ventilator shall switch to main supply with the AC LED lit 82 Complete Function Check Vivo 40 clinician s manual Doc 003886 En Us A te 10 Cleaning the Vivo 40 and Replacement of Accessories The patient connected parts and the filter must be cleaned and replaced regu larly to ensure correct function of the Vivo 40 All replaced parts must be dis posed of in accordance with local environmental regulations regarding the disposal of used equipment and waste 10 1 Cleaning the Vivo 40 WN To avoid electrical shock disconnect the ACpower supply to the Vivo 40 before cleaning Do not immerse the Vivo 40 into any fluids t Always be careful when cleaning to ensure that you do not damage any equipment Hluid must not be allowed to enter into the Vivo 40 Do not sterilize the Vivo 40 Main Unit 1 Switch off the Vivo 40 and dis connect the power supply 2 Remove the patient circuit Cleaning the Vivo 40 and Replacement of Accessories 83 Doc 003886 En Us A te Vivo 40 clinician s manual 3 At regular cleaning after nor
58. mage Note Information that may be valuable but is not of critical impor loss of data extra work or unexpected results tance tips A Reference lb Reference to other manuals with additional information on a specific topic Introduction 7 Doc 003886 En Us A 1e Vivo 40 clinician s manual 2 Safety Information 2 1 General User Precautions The Vivo 40 must be switched off and on at least once a day This is neces saty in order for the Vivo 40 to perform a self test US Federal law restricts this device for sale by or on order of a physician The Vivo 40 should not be used for any kind of total ventilatory require ment The Vivo 40 shall only be used by patients with spontaneous breathing Advice contained in this manual should not supersede instructions given by the prescribing physician f the patient is admitted to a hospital or is prescribed any other form of medical treatment always inform the medical staff that the patient is on mechanical ventilation treatment Vivo 40 must only be used for the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel in accordance with the operating conditions specified in this operating manual in original and unmodified shape and only with accessories specified or approved by Breas Medical AB Do not use the Vivo 40 in the event of suspected damage to the
59. mal use keep the rear lid of 4 HA 01 humidifier attached X Y In case a more thorough cleaning is O needed detach the rear lid or the A HA 01 humidifier M 4 Disconnect all electric cables 5 Clean the outside of the Vivo 40 using a lint free cloth and a mild soap solution If the surface of the Vivo 40 needs to be disinfected this can be done with Virkon or Gigas ept 6 Reconnect the patient cir cuit Make sure all parts are dry before the Vivo 40 is put into operation HA 01 Humidifier The HA 01 humidifier should be cleaned maintained and replaced in accordance with the manufacturer s instructions For more information see Breas HA 01 Humidifier User Manual Patient Circuit The patient circuit shouid always be cleaned disinfected and replaced in accordance with the applicable manufacturers instructions Always replace the patient circuit with a new one when the Vivo 40 is to be used by a new patient 84 Cleaning the Vivo 40 and Replacement of Accessories Vivo 40 clinician s manual Doc 003886 En Us A te All parts that come into contact with the respiration gas must be cleaned as fol lows Place the dismantled parts in hot water containing mild detergent Remove fouling with a brush Rinse parts thoroughly under running hot water 1 2 3 4 Shake water out of all parts 5 Dry the parts completely 6 Store in dust free location Check the patient circuit for damage regularly
60. n s manual Doc 003886 En Us A 1e 12 3 Compliance of Standards STANDARD SPECIFICATION IEC 60601 1 1988 Medical electrical equipment Part 1 General A1 1991 requirements for safety A2 1995 IEC 60601 1 2 2001 Medical electrical equipment Part 1 2 Gen eral requirements for safety Collateral stand ard Electromagnetic compatibility requirements and tests IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 Gen eral requirements for safety Collateral Stand ard Programmable electrical medical systems IEC 60601 1 8 2003 Medical electrical equipment Part 1 8 Gen eral requirements for safety Collateral stand ard Alarm systems requirements tests and guidelines ISO 10651 6 2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6 Home care ventilatory support devices ISO 17510 1 2002 Sleep apnea breathing therapy Part 1 Sleep apnea breathing therapy devices ISO 8185 2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humid ification systems CAN CSA C22 2 Medical electrical equipement Part 1 General No 601 1 M90 requirements for safety CAN CSA C22 2 No 601 181 94 Supplement no 1 94 to CAN CSA C22 2 No 601 1 M90 Medical electrical equipe ment Part 1 General requirements for safety CSA 601 1 Amendment 2 1998 Do
61. ng treatment e Unexplainable or sudden pressure performance or sound changes during operation e Suspected damage to the device Maintenance 87 Doc 003886 En Us A 1e Vivo 40 clinician s manual 11 2 Service and Repair The service and repair of the Vivo 40 must be carried out by authorized service personnel in accordance with Breas service instructions Service inspections must always be carried out after any repair of the device g Authorized service workshops can order the Vivo 40 Service Manual that con tains all technical documentation required for the maintenance and service of the Vivo 40 11 3 Storage Empty clean and dry the HA 01 humidifier if applicable before storage of the Vivo 40 11 4 Disposal The Vivo 40 any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste QX accordance with the local environmental regulations e m Batteries used with the Vivo 40 shall be recycled in Vz 88 Maintenance Vivo 40 clinician s manual Doc 003886 En Us A 1e 12 Technical Specifications 12 1 System Description z 2 DESCRIPTION Air inlet filter Blower Silencer box Vivo 40 casing Pressure regulating valve Pressure sensor Flow sensor Ambient Humidifier HA 01 Patient tube Leak hole Mask
62. o the Mode section 2 Use the down arrow to navigate to the Device Mode setting Select the required mode with the and buttons Doc 003886 En Us A 1e Vivo 40 Total Op Time 47 Hour Pat Op Time O Hour Ver 5 96 5 94 2 01 UK108 Voltage AC O Voltage DC 0 Volt Internal Battery Status C Return to Others Menu TRUE 18 C3 Est Tidal Vol 0 231 Total Rate 8 bpm Leakage 22 Vin Device Information Mode Set U Alarm VENTILATOR OFF Time and Date Time 12 33 Date 1 1 2004 Time Format 24h Return to Others Menu Mode SetU Alarm Est Tidal Vol 028 Total Rate 8 bpm Leakage entilation Mode Pv Psv cpap Patient Mode Adult Paediatric Target Volume Inactive Device Mode Clinical Home CES EE 22 Vmin EERE SetUp Alarm Others eooe Total Rate lLeakage PCV Patient Adult Device Est Tidal Vol 0 22 entilation Mode Target Volume Inactive Home EIE NEI 8 bpm 21 Vmin PSV CPAP Mode Paediatric OO Mode I SetUp Alarm Others Using the Vivo 40 Vivo 40 clinician s manual 41 3 Press Go to home to change to 1 immi Est Tidal Vol 0 221 home mode EM oe Leakage 21 Vmin entilation Mode PSV CPAP Patient Mode Adult Paediatric Target Volume Active Inactive Device Mode 4 In home mode navigate to th
63. owever the iCom is con siderably slower than the memory catd With the iCom real time data can also be received and sent between the Vivo 40 and a PC 46 Using the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A te 1 Connect the Vivo iCom data cable to the Vivo 40 Make sute it is fitted correctly 2 Connect the other end of the Vivo iCom data cable to the iCom 3 Connect the iCom PC data cable between the iCom and a PC Do only use either the D sub cable or the USB cable Using the Vivo 40 47 Doc 003886 En Us A 1e Vivo 40 clinician s manual 5 6 Using the HA 01 Humidifier Information about safety warnings product description installation usage cleaning maintenance and technical specifications can be found in the Breas FLA 01 Humidifier User manual PN Read the chapter Humidification on page 16 carefully to make sure all conditions are fulfilled and considered o If the AC power source fails and the internal or the external battery acti vates the HA 01 humidifier will be turned off automatically It must be activated again manually if humidification during battery use is neces sary The HA 01 humidifier is intended to humidify the patient air The HA 01 humidifier must be installed in order to access and navigate to the humidifier setting on the Vivo 40 menu both in clinical and home mode The HA 01 humidifier can only be activated if the Vivo 40 is operating Ifthe HA 0
64. patients such as patients with abnormalities of the cribriform plate or prior history of head trauma The use of CPAP therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection About this Manual Always read this manual before setting up and using the Vivo 40 or per forming maintenance on the machine to ensure correct usage maxi mum performance and serviceability o Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification ES Audience This manual is primarily intended for care providers clinical personnel physi cians and others who require a working knowledge of the Breas Vivo 40 system The manual comprises detailed information on the settings and functions of the Vivo 40 to be handled by trained health care personnel only Patents and other lay users operating the Vivo 40 will find all the informa tion they need in the User Manual Setvice personnel may order the Vivo 40 Service Manual that contains detailed technical information for maintenance service and repair 6 Introduction Vivo 40 clinician s manual Doc 003886 En Us A 1e Icons In this manual icons are used to highlight specific information The meaning of each icon is explained in the table below ICON EXPLANATION Warning Risk of death and serious personal injury Caution Risk of minor or moderate injury Risk of equipment da
65. r into the mask or patient tube 15 The high pressure alarm shall be activated after 3 consecutive high pressure breaths Check the Low Pressure Alarm 16 Enter standby mode by stopping the treatment 17 Connect the patient circuit to a test lung 1 5 I and a leakage connector 18 Adjust the IPAP to 12 cmH5O and the low pressure alarm to 10 cmH5O 19 Enter operating mode by starting the treatment 20 Adjust the IPAP to 5 cmH5O 21 The low pressure alarm shall occur within 30 seconds 22 Adjust the IPAP to 12 cmH5O 23 The alarm shall disappear Check the High Breath Rate Alarm 24 Adjust the ventilator settings as follows SETTING VALUE IPAP 15 cmH O EPAP 10 cmH O Set tate 20 BPM High breath rate alarm 10 BPM 25 The high breath rate alarm shall occur within 30 seconds Complete Function Check 81 Doc 003886 En Us A te Vivo 40 clinician s manual 26 Adjust the set rate to 5 BPM 27 The alarm shall disappear in 30 seconds Check the Low Breath Rate Alarm 28 Adjust the ventilator settings as follows SETTING VALUE Set tate 5 BPM High breath rate alarm Off Low breath rate alarm 15 BPM 29 The low breath rate alarm shall occur within 30 seconds 30 Adjust the set rate to 20 BPM 31 The alarm shall disappear in 30 seconds Check the Low Volume Alarm 32 Adjust the ventilator settings as follows SETTING VALUE High breath rate alarm Off Low volume alarm 201 33 The low volume alar
66. ry drive The use of the Vivo 40 for positive pressure therapy may be contraindicated on patients Incapable of maintaining life sustaining ventilation in the event of a brief circuit disconnection or loss of therapy Unable to maintain a patent airway or adequately clear secretions At tisk for aspiration of gastric contents With a history of allergy or hypersensitivity to the mask materials where the tisk from allergic reaction outweighs the benefit of ventilatoty assistance Therapy with the Vivo 40 should not be prescribed when the following specific diseases or conditions are present Doc 003886 En Us A 1e Bullous lung disease Pathologically low blood pressure Severe cardiac arrhythmias Coronary artery disease Unstable angina pectoris Decompensated cardiac failure or hypotension particularly if associated with intravascular volume depletion Recent thoracic surgery Pneumothorax Pneumomediastinum Introduction 5 Vivo 40 clinician s manual e Massive epistaxis or previous history of massive epistaxis risk of recurrence Pneumoencephalus recent trauma or surgery that may have produced cranio nasopharyngeal fistula e Cerebral spinal fluid CSF leaks Acute or unstable respiratory failure or insufficiency Conditions predisposing to a risk of aspiration of gastric contents Impaired ability to clear secretions Caution should be used when prescribing positive airway pressure therapy for susceptible
67. s less than the low breath rate alarm limit for 15 seconds Possible cause e Setting is higher than breath rate The patient doesn t trigger any breaths Decrease of the patient s spontaneous breath ing Setting Parameter Low breath rate Min Max Resolution 4 BPM 50 BPM 1 BPM Ventilator action The Vivo 40 will continue to give breaths with the same settings Indication eT 0 32 8 b E UC sE 14 0 cmH20 a 4 0 cmH20 IX 8 bpm Insp Time 25 s C Press Set Up for more settings Mode NAN Alarm Others The alatm is given audibly with a tone and visibly by the yellow alarm LED and a display message 72 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e Doc 003886 En Us A 1e ITEM High Breath Rate Alarm DESCRIPTION Definition A high breath rate alarm will be given when the delivered breath rate exceeds the high breath rate alarm limit for 15 seconds Possible cause The alarm for high breath rate is activated if the patient hyperventilates or if the ventilator starts to self trigger because of incorrect settings Setting Parameter High breath rate Min Max 10 BPM 60 BPM Off Resolution 1 BPM Ventilator action The Vivo 40 will continue to give breaths with the same settings Indication eT 4 HIGH BREATH RATE Est Tidal Vol otal Rate 0 34 i 9 bpm Leakage l e 2 22 l min 13 10 st IPAP 14 0 cmH20 cs
68. sub D sub to D sub 18 iCom PC data cable Data cable iCom and PC 003722 USB USB to USB 19 Memory card Vivo 40 settings patient data 003619 and usage data 20 Memory card reader Read write memory card 002185 writer 21 Vivo PC software kit Data monitoring software 004145 Doc 003886 En Us A 1e Product Description Vivo 40 clinician s manual 23 24 3 3 The Vivo 40 s Front Panel NO USER BUTTONS 1 Start Stop FUNCTION Start Stop ventilation treatment 6 Audio pause Pause the alarm sound 7 10 Function Navigation Function according to display 14 17 Navigation Setting Navigation in current menu selection Define settings No LED FUNCTION 2 Trigger Patient breath trigger indication 3 4 Alarm red amp yellow Alarm indication 5 Audio pause Paused alarm sound indication 11 AC power Power source AC power 12 External DC Power source External DC 13 Internal battery Power source Internal battery No DISPLAY WINDOW FUNCTION 18 Monitoring section Current treatment data 19 Active section Adjustable settings Product Description Vivo 40 clinician s manual Doc 003886 En Us A 1e 3 4 The Vivo 40 s Back and Side Panels Doc 003886 En Us A 1e No ITEM FUNCTION 1 Air inlet Air path in replaceable filters 2 Locking mechanism Release and lock t
69. switching the Vivo 40 on see Switching the Vivo 40 On and Off on page 36 Enter standby mode by switching the Vivo 40 off again Some operations such as accessing the memory card and setting time and date are only available in standby mode 4 10 Low Leakage Detection The Vivo 40 automatically detects if the mask and tubing fitted to the device has sufficient leakage If the leakage measured is below the recommended level it will generate a Low Leakage Alarm The Vivo 40 will continue to deliver breaths during the alarm Check mask leakage exhalation port and tubing and if necessaty clean ventila tion holes if clogged 4 11 Humidifier optional The humidifier function is adjustable to provide additional humidity to the patient air 34 Functions and Parameters of the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 5 Using the Vivo 40 5 1 Setup the Vivo 40 Before Use Always do the following before using the Vivo 40 1 Connect a cleaned ot new patient circuit to the Vivo 40 2 Connect the Vivo 40 to the AC power source 3 Switch on the Vivo 40 main power using the On Off switch on the side panel 4 Press the Start Stop button on the front panel Check that a short sound signal is heard If there is no signal do not use the Vivo 40 and contact your setvice provider 5 Ensure that the settings are adjusted as prescribed The Vivo 40 is ready for use Using the Vivo 40 35 Doc 003886 En Us A 1e Vivo
70. t pressure to the patient and reference ambient pressure so that the device automatically will compensate for altitude changes The internal memory of the Vivo 40 can be downloaded to a PC where you can view the patient compliance data in the Breas Vivo PC Software 3 For more information about the Breas Vivo PC Software please contact your Breas representative 1 2 Intended Use The Vivo 40 is an assist ventilator intended to augment the breathing of spon taneously adult patients gt 66 lbs gt 30 kg suffering from respiratory failure res piratory insufficiency ot obstructive sleep apnea The Vivo 40 is not intended to provide the total ventilatory requirements of the patient The Vivo 40 is intended to be used for both invasive and non invasive applica tions 4 Introduction Vivo 40 clinician s manual Doc 003886 En Us A 1e The Vivo 40 is intended to be operated by qualified and trained personnel The Vivo 40 is intended for use in clinical settings e g hospitals sleep labora toties sub acute care institutions and home environments The Vivo 40 must always be prescribed by a licensed physician The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea via non invasive nasal ot full face masks 1 3 Contraindications The use of the Vivo 40 is contraindicated on patients with severe respiratory failure without a spontaneous respirato
71. tall the leakage port as close as possible to the patient connection to reduce the risk of rebreathing CO When using the Vivo 40 invasively the low volume alarm and the low breath rate alarm must be carefully set to ensure safe use The highest output from the HA 01 humidifier is 30 mgH O litre which means that it does not fulfill the humidifier standard for invasive use The Vivo 40 is equipped with a low leakage alarm The low leakage alarm is not a substitute for operator vigilance in ensuring that the leakage ports remains clear at all times Periodically check the leakage ports during ther apy In general as pressure decreases the potential of rebreathing increases Lower pressures produce less flow through the leakage ports which may not clear all CO from the circuit to prevent rebreathing n general as inspiratory time increases the potential of CO rebreathing increases A higher inspiratory time decreases the expiratory time allowing less CO to be cleared from the circuit before the next breath I E inspira tion time expiration time ratios close to 1 1 increase the potential of CO tebreathing Tracheal tubes oral nasal tubes etc with small inner diameters increase the tesistance in the breathing circuit An external heated humidifier approved for invasive use ot an appropriate HME Heat and Moisture Exchanger artificial nose HCH Hygroscopic Condenser Humidifier is recommended 14 Saf
72. ting range 1 to 9 where 1 is the most sensitive Navigate to the section Setup and press Setup one more time to reach the More Settings page o 10 20 30 40 Est Tidal Vol 0 221 Total Rate 44 bpm Leakage 15 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Rise Time 3 Je Inspiration Trig 6 Expiration Trig ae Min Insp Time Off Max Insp Time Off Target Volume 100 IPAPmax 20 0 cmH2O Mode Alarm Others Target Volume PSV amp PCV only Target Volume active Navigate to the section Mode and then to Target Volume Use the F and buttons to select Active or Inactive Follow the on screen instructions and adjust the parameters according to the prescribed treatment Setting range 0 2 to 1 51 Navigate to the section Setup and press Setup one more time to reach the More Settings page D0 20 0 40 Est Tidal Vol 0 28 Total Rate B bpm lLeakage 21 Vmin Ventilation Mode PSV CPAP Patient Mode Adult Paediatric Target Volume Inactive Device Mode Clinical Home Set U Alarm Others A m 17 Est Tidal Vol 0 21 Total Rate 8 bpm Leakage 18 l min IPAPmin 14 0 cmH20 EPAP 40 cmH20 Set Rate 8 bpm Inspiration Time 25 s Rise Time 3 uk Inspiration Trig 6 Target Volume 1 00 IPAPmax 20 0 cmH20 Press Set Up for Basic Setting Mode Alarm Others
73. tor action The Vivo 40 will terminate inspiration from the first high pressure breath The Vivo 40 will then continue to give breaths with same settings Indication Total Rate 8 bpm IPAP EPAP 4 0 cmH20 Set Rate 8 bpm Insp Time 25 s Press Set Up for more settings Alarm Others The alarm is given audibly and visibly by the red alarm LED and a display message 70 Alarms Vivo 40 clinician s manual Doc 003886 En Us A 1e Low Volume Alarm ITEM DESCRIPTION Definition A low volume alatm will be given when the Vivo 40 s volume fails to reach the low volume alarm limit for 15 seconds 45 seconds after start up and after cancelling a high leakage alarm Possible cause Restrictions in airways e Obstructed or occluded patient circuit Setting Parameter Low volume Min Max Resolution 0 031 2 01 0 051 Ventilator action The Vivo 40 will continue to give breaths with the same settings Indication Doc 003886 En Us A 1e eT Ye IPAP 14 0 cmH20 mies EPAP 4 0 cmH20 e X Set Rate 8 bpm 25 s Insp Time Press Set Up for more settings Mode NAN Alarm Others The alarm is given audibly with a tone and visibly by the red alarm LED and a display message Alarms Vivo 40 clinician s manual 71 Low Breath Rate Alarm Apnea alarm ITEM DESCRIPTION Definition A low breath rate alarm will be given when the delivered breath rate i
74. umidifier User Manual 3 Replace the patient filters according to Cleaning and Replacing the Patient Ait Filters on page 85 4 Ifalow resistance bacteria filter is used it shall be replaced 5 Use a new patient circuit when the Vivo 40 is used by a new patient 86 Cleaning the Vivo 40 and Replacement of Accessories Vivo 40 clinician s manual Doc 003886 En Us A te 11 Maintenance WARNING Vivo 40 should be subjected to maintenance service and control and any applicable upgrades in accordance with Breas service instructions Vivo 40 shall only be repaired or modified in accordance with Breas service manuals technical bulletins and any special serv ice instructions by service technicians that have been authorized after Breas Vivo 40 service training or have an equivalent techni cal knowledge on medical device Do not under any circumstances attempt to service or repair the Vivo 40 yourself If you do so the manufacturer will no longer be responsible for the performance and safety of the Vivo 40 DEVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF PERSONAL INJURY 11 1 Regular Maintenance Control Regular maintenance inspections and controls shall be carried out at least every 12 months Maintenance control according to the Vivo 40 Service Manual Do not use the device and contact your responsible care provider for an inspection of the device in the event of Unexpected patient symptoms duri
75. ure rate inspiration time and rise time settings Inspiration is started either when the ventilator initiates a breath or when the patient triggers a breath if the trigger function is activated The ventilator tries to reach and maintain the set pressure until the expiration starts The inspiration stops and an exhalation starts in two cases Theinspiration time expires The limit for the high pressure alarm is reached The figure below shows how the pressure and the inspiration time settings con trol the ventilator s function in the PCV mode The following settings have been used Pressure 20 cmH O insp time 1 8 sec Pressure cmH5O 20 F greenene IPAP Pressure setting E Patient exhales seconds I I I l I Max flow and set pressure is reached Patient exhales seconds 30 Functions and Parameters of the Vivo 40 Vivo 40 clinician s manual Doc 003886 En Us A 1e 4 5 The PSV Mode Pressure Support Ventilation In the PSV mode the patient normally controls both the inspiration through the inspiratory trigger and the exhalation by the expiratory trigger Inspiration is started when either the patient triggers a breath if the trigger is activated or when the breath rate setting initiates an inspiration The ventilator tries to reach and maintain the set pressure until the expiration starts Inspiration stops and an exhalation starts in three cases The inspiration flow has dropped to the va
76. vo 40 for any kind of total ventilatory requirement Breas Medical AB reserves the right to make changes to this product without any prior notification Introduction 3 Doc 003886 En Us A 1e Vivo 40 clinician s manual 1 4 What is the Vivo 40 The Vivo 40 is a pressure supported and pressure controlled ventilator It has three modes of operation PCV Pressure Control Ventilation PSV Pres sure Support Ventilation and CPAP Continuous Positive Airway Pressure The PCV and PSV modes have an adjustable inspiratory trigger sensitivity setting which allows the patient to initiate ventilator assisted breaths In the PCV mode Pressure Control Ventilation the ventilator provides assisted or controlled pressure regulated breathing In PCV mode the clini cian sets an inspiration time The inspiratory pressure is set by the IPAP Inspiratory Positive Airway Pressure setting The end expiratory pressure is set by the EPAP Expiratory Positive Airway Pressure setting Inthe PSV mode Pressure Support Ventilation the ventilator s expiratory trigger can also be adjusted allowing the ventilator to more easily match each patient s needs The inspiratory pressure is set by the IPAP setting The end expiratory pressure is set by the EPAP setting In the CPAP mode Continuous Positive Airway Pressure the ventilator provides a continuous positive airway pressure The Vivo 40 has a pressure sensor that continuously monitors outpu
77. wing components esI XSite QUT yy 20 Product Description Vivo 40 clinician s manual Doc 003886 En Us A 1e No COMPONENT FUNCTION PART NO 1 Carry bag Storage for transportation 003519 2 User manual Product and usage information 003819 9 Patient tube 004465 4 Power cord 003522 5 Filter white disposa Inlet air filtration 003526 ble 6 Filter grey washable Inlet air filtration 003527 7 Rear lid For usage without 003591 the HA 01 humidifier 8 Vivo 40 main unit Product Description 21 Doc 003886 En Us A 1e Vivo 40 clinician s manual 3 2 Accessories No COMPONENT FUNCTION PART NO 9 HA 01 Humidifier Humidifies patient air 003530 10 Trach elbow Trach connection 004810 11 Hygroscopic Con Humidifier 003974 denser Humidifier HCH 12 Leakage Exhalation Providing a leakage 004426 port 22 Product Description Vivo 40 clinician s manual Doc 003886 En Us A te No COMPONENT FUNCTION PART NO 13 Battery cable 12 24 V 004258 DC 14 iCom kit Includes 004143 Isolated communication interface PC and Vivo Vivo iCom data cable iCom PC data cable D sub iCom PC data cable USB iCom User manual iCom PC drivers 15 Vivo PC data cable Data cable PC and Vivo 40 003588 RJ45 to D sub 16 Vivo iCom Data cable Vivo 40 and iCom 003574 data cable RJ45 to D sub 17 iCom PC data cable Data cable iCom and PC 003721 D

Vivo 40 must only be used

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