Precision Flow®
Contents
1. TEMPERATURE display in C FIGURE 5 1 1 Set up and Power On Test Duration Approximately 5 minutes 1 1 Install an oxygen sensor into the Precision Flow unit See the Precision Flow Operating Instructions Manual Section 6a Oxygen Sensor Installation for additional information 1 2 Affix the Precision Flow unit to an IV pole or test rack Do NOT install Disposable Patient Circuit DPC at this time 1 7 Verify that ALL pixels on the LED display illuminate The LED pixel check is automatically initiated when the Precision Flow is connected to AC power and lasts approximately 3 seconds 1 8 Verify that the light above the run stop button on the front panel turns amber 5 1 Technical Service Manual 3004005 Rev K f gt PRECISION OW Section 5 Pre use Checklist 1 9 Verify that the following is displayed on the LED 2 1 Install a Low Flow DPC into the Precision Flow See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 2 2 Verify that The DWP icon is illuminated The General Cartridge Icons go out The Low Flow Cartridge Icon is illuminated See Figure 5 1 for Icon Legend 2 3 Using the control knob verify The gas flow is adjustable from 1 L min to 8 L min 0 5 L min Resolution The oxygen percentage is adjustable from 21 to 100 1 Resolution The temperature range is adjustable from 33 to 43 C 1 C Resolution See the Precision Flow Operati2. VAPOTHERM Precision Flow Technical Service Manual 3004005 Revision K This document contains proprietary information to Vapotherm Corporation and its receipt or possession does not convey any rights to reproduce its content or to manufacture or sell any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of Vapotherm Corporation is strictly forbidden This Technical Service Manual is subject to change without notification Revision Change Record REVISION ECO 12 015 12 01 EE Important Safety Information This manual is subject to periodic review update and revision Always obtain and consult the latest revision before undertaking any service of the equipment Before performing any service on the Precision Flow read and review this entire manual After performing any service or repair always perform the pre use checkout in section 5 of this manual All tests must pass before unit can be put back in service Always disconnect the electrical power and gas supplies before performing service or maintenance procedures detailed in this manual Reconnect only if you are specifically instructed to do so as part of the procedure Genuine replacement parts manufactured or sold by Vapotherm must be used for all repairs Technical Competence The procedures described in this service manual should only be performed by competent individuals who have a gen
3. D WEE 4 3 4 2 4 Cleaning and GISINFECEON sed sd ie l ss klan Aaaa Aa ka de oe ge ee kana h ud Ge dek ie ed ee de k n lk ed de han 4 3 Section 5 Pre Use Checklist 5 1 Precision Flow Pre Use Checklist ses n Ee OE De De ee da ie k k re a Ge DE Ee 5 1 Section 6 Tools and Eduipment 6 Toolsaid QUOC NU ee 6 1 Section 7 Service Parts NS Go g a de ae EE Ed E EE EE ee ere ee eee 7 1 For further information contact Ec REP RMS UK Limited 28 Trinity Road Nailsea North Somerset BS48 4NU United Kingdom Vapotherm Inc 22 Industrial Drive Exeter NH 03833 USAPhone 603 658 0011 Phone 44 1275 85 88 91 Fax 603 658 0181 Fax 44 1275 85 88 91 www vtherm com May be patented www vtherm com patents PRECISION OV Section 1 General Information 1 1 Introduction The Vapotherm Precision Flow is intended to heat and humidify patient respiratory gases from a source of compressed air and oxygen gases Warm humidified gas is delivered from the Vapotherm Precision Flow to the patient via a proprietary tube set and disposable water path that is attached to a nasal cannula or mask at the patient The user can set the oxygen percentage temperature and flow rate of the delivered gas The unit is intended to be pole mounted attached to an overhead sterile bag of water Heat and humidification are provided through an exchange cartridge that is placed between the disposable water path and the capital side of the unit This cartridge a
4. Thermometer with thermocouple 6 1 Technical Service Manual 3004005 Rev K Section 6 Tools amp Equipment PRECISION Ow 7 1 Rear panel parts O o N 9 QI gt Q N 16 17 18 19 Screw Philips Ee 3000172 Cover O2 Sensor 3000004 Label O2 sessie ke 3003002 Label Air 3003001 Label 80 20 Heliox 3200015 Label Do Not Block 3003003 GCA e su sk N sek NEE 3003456 3 8 16 Knob screw 3003458 Screw T 20 Skt H4d 3010308 Retainer Power Cord 3000059 Fuse Drawer iese ee ee EE Ee 3000137 FUSE OE N TE 3000135 Screw T 15 Skt Hd 3010324 Screw black nylon 3000178 1 8 trap assy DISS O2 3000138 1 8 trap assy NIST O2 3000139 1 4 trap assy DISS AIR 3000140 1 4 trap assy NIST AIR 3000141 NIST Body adapter O2 CA 3000142 NIST Body adapter Air CA 3000143 Technical Support Line Label 3100399 e 13 ma AR Parts not shown O2 sensor cel l 3003011 U S power cord is ss 3003019 U K power cord ees 3003018 E U power cord 3003017 Australia power cord 3003024 Japan power cord 3003026 Korean po
5. and confirm correct flow is within range of the cannula label Replace water bag or straighten inlet tube Restart unit Replace DPC Replace IR Detect PCB in LS2 position Replace DPC If this does not remove the fault send the unit in for repair The internal battery backup is not fully charged The unit would not run on battery for the full rated time in the event of a power failure No action is necessary Unit running in BATTERY mode Gas flow amp blending continue without heat or water circulation AC power disconnected 3004005 Rev K Reconnect AC power PRECISION OW Alarm Icons Table Section 2 Troubleshooting Cartridge fault cartridge alarm icon Medium Priority flashes Cartridge fault continuous Cartridge type LO or HI Gas supply flashing Gas supply con tinuous and flow rate numeric display flashes Medium Priority Medium Priority Medium Priority Cannot be muted Temperature display shows dashes flashing d Temperature numeric amp General Fault icon display flashes System Display Icons System Display or Alarm Amber LED light Green LED Blinking Green LED Solid DWP blinking No battery Icon Battery Mode amp discharged Low Priority None None Cartridge not detected Unit will not run Gas bubbles in water circulation Unit continues to operate Cartridge not detected RUN mode faulty sensor or cartrid
6. through the outer lumens of the delivery tube Returning water passes through the outer jacket of the vapor transfer cartridge where some water is lost as vapor to the gas stream There is no direct contact between water and gas flows The water then returns to the reservoir Heater power is regulated continuously to maintain the set temperature Water replaces evaporative losses in the vapor transfer cartridge via a gravity fed sterile water supply Air is purged to atmosphere from the circulation via an oleo phobic filter membrane For a description of the software operating modes see Mode Diagram 1 3 Technical Service Manual 3004005 Rev K gt f PRECISION OW Section 1 General Information FAULT MODE POST Fail POST Pass POWER OFF STANDBY MODE AC Off Run Button Run Battery Button Exhausted dee ke BATTERY MODE Run AC Off Button Figure 1 3 Software Mode Diagram The previous diagram illustrates the operating modes for the unit 1 4 Immediately on connection to AC power a POST Power On Self Test is run to verify proper function of subsystems sensors and actuators in the Precision Flow On successfully completing the POST if there is a DWP in place the unit enters STANDBY unless there is a test failure The system will indicate FAULT mode in the temperature display The Precision Flow enters RUN mode from STANDBY when the RUN STANDBY button is pressed Normal operation starts The pump heater and
7. 3 4 display control wire harness 3 1 Technical Service Manual 3004005 Rev K Section 3 Corrective Maintenance control knob Figure 3 1 smoked display cover d is p lay VAPOTHERM gasket TI Fiqure 3 2 front cover nylon screws Figure 3 3 speaker grill PRECISION OW 3 2 Removing the back cover 3 2 Remove the two screws that secure the pole clamp to the rear of the unit Figure 3 5 with a Torx T 20 screwdriver and remove the clamp Loosen the three screws that secure the O2 sensor door with a Phillips screwdriver and remove the door Remove the eight mounting screws that secure the rear cover to the back plate with a Torx T 15 screwdriver and remove the rear cover Figure 3 5 3 3 Removing the side cover 1 Remove the front cover as described in section 3 1 and the rear cover as described in 3 2 Use a Phillips screwdriver to loosen the screw in the fan speaker bracket at the bottom of the side cover Figure 3 6 Remove the side cover Figure 3 7 3 4 Replacing the batteries or power supply 1 assembly Battery packs are to be replaced every 2 years Use the following date code to determine the age of the battery pack Year 2013 Remove the front rear and side covers as described in sections 3 1 3 2 amp 3 3 Month August Remove the two Torx T15 power supply mounting screws Figure 3 8 located on the back plate in the rear of the unit Disconnect power s
8. A D units to flow in liters per minute For any setting of flow and oxygen percentage the operating software calculates the target flows for oxygen and air or heliox The proportional solenoid valves are then adjusted until the measured flow for each gas equals the target flow The system continually monitors the flows and makes small adjustments to the solenoid valves as necessary to maintain the target flows As a check on the mixing and metering system an oxygen cell continually reads a sample of the mixed gas Alarms occur if either flow cannot be adjusted to the target flow if a mass flow sensor is out of range or if there is a discrepancy between the oxygen setting and the oxygen cell reading Firmware running in the main unit uses sensors to monitor gas pressure water level and water temperature and air leaks in the water circuit bubble detector Alarms are displayed if any parameters are outside the normal range Other indicators include backup battery charge and the type of cartridge installed See Mode Diagram for a description of the firmware states and transitions An internal battery backup will maintain the set flow and oxygen blend for at least 15 minutes without AC power However the circulating pump and heater will stop The battery is designed for temporary power loss and is not intended for transport Disposable patient circuit The disposable patient circuit is comprised of the disposable water path vapor transfer cartri
9. aining clips to them 4 Verify the door closes completely Technical Service Manual 3004005 Rev K retaining clip Figure 3 10 door retaining clip clevis pin Figure 3 11 clevis pin PRECISION OW Section 3 Corrective Maintenance A 3 6 Replacing the fan fan filter or speaker AA Remove the front rear and side covers as described in sections 3 1 3 2 amp 3 3 2 Use a Phillips screwdriver to loosen the screw that secures the fan speaker bracket Figure 3 12 and remove the assembly O To access the filter remove the four screws that secure fan bracket to the plastic grill panel Clean or replace the filter a 3 7 Front panel control repairs AA 1 Remove the front cover as described in section 3 1 screw Figure 3 12 fan speaker bracket 2 To remove the display PCB remove its four mounting screws with a Torx T 10 screwdriver 3 To remove the control knob slide the rubber knob off the stem then use a deep socket wrench to remove the nut on the outside of the front panel that holds the encoder in place Figure 3 14 Disconnect the 6 pin connector from the control board wire harness and remove the encoder 4 To remove the membrane PCB assembly remove its four mounting screws with a Torx T 10 screwdriver and disconnect the front panel wire harness from the membrane board Figure 3 15 The membrane and encoder assembly can be separated and replaced Take care to fully seat the gasket in the cu
10. approx 80VA in steady state depends on flow rate and temperature Back up power Qty 4 1 2V nickel metal hydride AA batteries 4 8V total not user replaceable Gas supply Medical air and oxygen or heliox at inlet pressures between 4 and 85 psi 28 586 KPa NOTE the full range of flows and oxygen percentage is available only if both gases are present at inlet pressures of at least 40 psi 276 kPa NOTE Units with serial numbers from PF 00001001 P to PFO0007040 P have gas supply inlet pressures between 4 and 70 psi 28 482 KPa Water Sterile water for inhalation in pre filled sealed container PERFORMANCE Temperature Range 33 to 43 C at exit from the delivery tube adjustable Resolution 1 C Accuracy 2 C Warm up time 2 C of 33 C set point lt 5 minutes at ambient 23 C Humidification Complies with 1508185 2007 Respiratory tract humidifiers for medical use paragraph 101 Oxygen percentage Range 21 to 100 O2 Resolution 1 Accuracy 2 O2 NOTE At 22 amp 23 oxygen blend the delivered oxygen is 21 Flow rate Resolution Low Flow 1 8 lpm 0 5 Ipm High Flow 5 40 lpm 1 Ipm Accuracy air configuration 1 8 lpm 0 5 Ipm or 10 lpm whichever is greater 9 40 Ipm 10 lpm Accuracy Heliox configuration 1 8 Ipm 0 5 lpm or 15 lpm whichever is greater 9 40 Ipm 10 lpm STANDARDS Designed to conform to the following standards IEC 60601 1 UL60601 01 1 5 Technical Service Man
11. cts as the interface to transfer heat from the water that is pumped through the exchanger transferring humidity by molecular passage of water vapor across the cartridge membrane surfaces The proprietary tube set and disposable water path insulates and maintains warm water with heat from an internal heater to surround the gas delivery tube and maintain its temperature as the gas makes its way from the Precision Flow to the patient cannula or mask This minimizes water condensation 1 2 Principles of Operation The Precision Flow unit is designed to blend and meter oxygen and air helium oxygen mixtures on Precision Flow Heliox units to set flow rates and oxygen percentages to warm and humidify that flow and then deliver it to the patient The vapor transfer cartridge is designed to receive the unconditioned breathing gas and add warm water vapor to it Two separate pathways one for the breathing gas and the other for the water intersect when fibers of a special membrane material allow water vapor to pass from the outside of the fiber into the gas stream A second unique feature of the Precision Flow unit is the heated vapor delivery tube The delivery tube delivers the humidified and warmed gases from the vapor transfer cartridge to the patient The heated delivery allows the breathing gas to pass through an inner tube that is surrounded by circulating warm water This insulates and maintains the inner tube to the same temperature as the
12. dge and delivery tube Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable water path Vapor transfer cartridge In the cartridge blended gas passes through the lumens of hundreds of parallel hollow fibers made of a specially developed polymer Warm water circulates around the fibers and diffuses as vapor through the fiber material into the gas stream flowing through each fiber There is no direct contact between the water and gas streams The gas stream leaves the cartridge essentially saturated with vapor at the set temperature Note Use only approved cartridges from Vapotherm Inc e Patient delivery tube The warmed humidified gas passes through the center of a triple lumen heated delivery tube The center lumen is surrounded by two outer lumens carrying warmed water to maintain the temperature of the inner lumen lumen and to minimize rain out A proprietary short nasal cannula is connected to the end of the delivery tube and passes the humidified breathing gas to the patient s nares 1 2 Technical Service Manual 3004005 Rev K PRECISION OV Section 1 General Information 3003277 FLOW CONTROL MANIFOLD FCM GAS METERING MANIFOLD e Disposable water path The disposable water path houses a water reservoir pump rotor connections for the cartridge and delivery tube and sensor interfaces to the main unit Water is pumped past a heater plate and circulates
13. ee 1 1 To PUIG UO Vell DESCA de EE 1 2 eegen GO EE OE EE EE ON el EE Ee DE ae RN Ne IE ET EE EE ER We 1 5 Section 2 Troubleshooting Ke E Eu EE OE AE EE OE EE EO N EE N 2 1 Section 3 Corrective Maintenance Sa errie gede OM COW zt beonyaw _ w_wa Prr rrr re N N Or 3 1 3 2 Removing the Dack COVEN E 3 2 sinan ea ie side ce ef sie es ee r ee ie bed ee eee Ee oe ee ee 3 2 3 4 Replacing the batteries or power supply assembly iss see ee ee ee RR ee ee RE kk ee keke ee 3 2 2 5 Replacing the hinged GOO ee DE ER ER AG ee ee Ee eo Ee aa karan d k ee 3 5 3 6 Replacing the tap fan fiter or speaker ses EG ed be y k Ge Ge ee ke k kn de Ge ee 3 4 AT FROWNED Ae COMO FO ANS RR SE ee RR se ei AR N Ge n ee GE Ge EG N EG ie Ee 3 4 Section 4 Preventative Maintenance D e EEN a NCS see Ro oe ei oe ie ee ee EE Go EG oe Ie Ro ee Ee oe ei eo A 1 4 1 1 Semi annual preventive maintenance sesse ee ee ee ee ee ee ee A 1 4 1 2 Annual preventive maintenance es N EG DE EG OS Ee GE GR EER ee KA KAKE Oe oe KE A 1 4 1 3 Bi annual preventive maintenance sesse ee ee ee ee ee ee ee ee ee A 1 4 d4 Order PARS EE 4 1 ALD Mamtenance Proc CCU SS es os tint acs ue settee tonne ness ee haste n de oe Ie 4 1 4 2 1 Inlet Gas Filter Replacement u i i lyil wal n k k l E W kesek san ana yA aw n aba W WA aa Vedan k 4 1 4 2 2 Oxygen Sensor Replacement iss kk kk ke KK ee K KAKA ee ee EE ee A KAK KAKA KA KAKA KA KAKA KAKA KAKA KK KA 4 2
14. eral knowledge of and experience with devices of this nature No repairs should ever be undertaken or attempted by anyone not having such qualifications Use a static strap and or a static control work station to ensure that static charges are safely conducted to ground and not through static sensitive devices Whenever this Electrostatic Discharge ESD symbol Aviad appears beside a procedure follow appropriate static control precautions LIMITED WARRANTY Vapotherm Inc warrants that the Precision Flow shall be free of defects of workmanship and materials and will perform in accordance with the product specifications for a period of 1 year from the date of sale by Vapotherm Inc If the product fails to perform in accordance with the product specifications Vapotherm Inc will repair or replace at its option the defective material or part This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship VAPOTHERM INC DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS LOSS OF PROFITS OVERHEAD OR CON SEQUENTIAL DAMAGES WHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OF THIS PRODUCT THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES Copyright 2012 Vapotherm Corporation All rights reserved Printed in the U S A TABLE OF CONTENTS Section 1 General Information e lege alte den EE E EE N EE N EO N 1 1 1 2 Pririeiplesor Operation Ee ee DR Ad ee
15. erify the DPC heater plate is clean and free of blemishes and scratches Ensure the Delivery Tube does not rest against metallic or cold surfaces Foreign matter or scratches on the DPC heater plate may impact the ability of the Precision Flow to reach set temperature See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 7 3 Attach a sterile water bag to the DPC by inserting the spike into the spike part of the bag and allow the DPC to fill with water The Water Out Icon may blink until the DPC has 7 4 Verify that the water bag icon goes dark It may take up to 90 seconds for the DPC to completely fill with water and the Water Out Icon to clear 7 5 Adjust settings to 5 LPM 33 C 21 O and press the RUN button 7 6 Wait until temperature displayed on the LED reaches 33 C This may take up to 5 minutes when testing at an ambient temperature of 23 T The temperature display will flash the temperature of the water in the DPC and the green light above the run stop button will flash until the unit reaches set point The unit is at 33 when the temperature display is no longer flashing and the green light above the run stop button stops flashing 7 7 Insert a calibrated thermistor thermometer 2 to 3 inches into the distal end of the delivery tube Placing large instruments into the flow path may trigger an occluded tube alarm If an occluded tube alarm is triggered leave the therm
16. ery recharges in 2 hours 4 1 4 Ordering PM parts Washer a Sek You can order the above PM parts by contacting VAPOTHERM Filter Buz AN Total Customer Care Department at 866 410 9986 email purchase order to ce vtherm com or Fax to 603 218 6111 CED 4 2 Maintenance Procedures Retaining Core Dees 4 2 1 Inlet Gas Filter Replacement 1 Unscrew trap bowl to expose filter element 2 Unscrew black retaining core to release filter assembly 3 Pull off and discard old filter element Install new element by pressing it on to the black plastic retaining core Fit the Bowl aluminum washer over the threaded end of the core a 4 Screw the assembled filter element into the housing Replace the clear plastic trap bowl CAUTION The trap bowl must be screwed tightly into the housing to prevent gas leaks Figure 4 1 filter assembly 4 1 Technical Service Manual 3004005 Rev K PRECISION OV 9 Section 4 Preventative Maintenance The inlet gas filter must be installed in the unit with the filter bowl down Note Precision Flow Heliox units do not use inlet gas filters 4 2 2 Oxygen Sensor Replacement The oxygen sensor should be replaced annually It is accessible by removing the panel at the back of the unit Ls CAUTION Sensor should be hand tight only Do not use tools 4 5 4 2 Remove three 3 securing screws from the access panel Pull the panel away from the unit Disconnect the cable connector grasp
17. gas flow proportioning systems start Flow temperature and oxygen can be set Some alarms activate immediately while others are on delay See table in Troubleshooting To return to STANDBY the RUN STANDBY button is pressed again If AC power is disconnected only when the unit is in RUN mode it enters BATTERY mode If the battery is fully charged gas mixing and metering continues for at least 15 minutes but water is not circulated or heated When the battery is discharged the unit enters the POWER OFF mode without an alarm If AC power is disconnected in STANDBY the unit enters POWER OFF mode If the RUN STANDBY button is pressed when in BATTERY mode the unit enters POWER OFF mode and will not re enter the RUN mode until power is restored There is no ON OFF button Technical Service Manual 3004005 Rev K PRECISION OV Section 1 General Information 1 4 Specifications PHYSICAL CHARAGTERISTICS Dimensions Height 11 5 300mm width 8 200mm depth 7 180mm excluding IV pole clamp and gas filters Weight 10 6lb 4 81Kg without disposable patient circuit Circulating Water Volume 400 ml approx including delivery tube and cartridge Mounting Rear mounted clamp fits IV poles up to 1 5 38mm diameter Gas Connections Standard DISS non interchangeable fittings for medical air and oxygen FUSES Qty 2 GMA 3A F250 V 5mm x 20mm SYSTEM REQUIREMENTS Power 100 240VAC 50 60Hz approx 200VA during warm up
18. gas flowing through it thereby keeping the gases at the desired temperature and eliminating condensation The water circuit begins at the auto feed reservoir where it is pumped into a process controlled heater The heated water then flows to the outer lumen of the delivery tube After the heated water has passed through the entire length of the outer jacket of the delivery tube it returns to unit and is passed through the vapor transfer cartridge From there it completes the loop by flowing back to the input side of the pump Temperature is sensed just downstream of the cartridge 1 1 Technical Service Manual 3004005 Rev K PRECISION OW Section 1 General Information 1 3 Functional Description The Precision Flow warms and humidifies a flow of breathing gas for delivery by nasal cannula at flows from 1 to 40 lom The unit incorporates an electronic blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently The Precision Flow consists of two parts Main unit The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers and sensors to monitor the disposable water path Flows of oxygen and air or heliox are regulated by proportional solenoid valves in the gas metering manifold The flows of oxygen and air or heliox are measured by two mass flow sensors in the flow control manifold Lookup tables stored in the processor convert
19. ge not detected Excessive gas diffusion through cartridge fibers STANDBY mode missing cartridge Remove disposable patient circuit Check cartridge installation Check reflective label on cartridge Check sensor windows are clean Disconnect patient Shut off unit Replace disposable pa tient circuit including water path cartridge amp delivery tube Remove disposable patient circuit Check cartridge installation Indicates type of cartridge installed low or high flow Not an alarm Gas supply pressure outside 4 85 psi 28 586 kPa range Selected flow can not be provided from Current gas supply Temperature out of range Unit will not operate Temperature 2 gt set point Temperature 2 lt set point Standby Mode Run has not reached set pt Run reached set point Gas supply is disconnected or exhausted Inlet gas pressure too low for selected flow rate Overheating or temperature sensor malfunction User enters set point much lower than previous temperature Very low water temperature after bag replacement Ensure supply gas pressure is between 40 amp 85 psi for full device flow range Replace GMM wire harness Ensure supply gas pressure is between 40 amp 85 psi for full device flow range Replace GMM wire harness Remove and replace DPC Replace IR Temp sensor wire harness Replace heater assembly Silence alarm and wait for temperature t
20. hnis Sin EE ro N bemnegenienmnen E or hardware inconsistency Contact Vapotherm Technical Support Technical Service Manual 3004005 Rev K PRECISION OW Use a static strap and or a static control work station to ensure that static charges are safely conducted to ground and not through static sensitive devices Whenever this Electrostatic Discharge ESD A symbol appears beside a procedure follow Gei appropriate static control precautions 3 1 Removing the Front Cover The smoked Plexiglas display cover snaps into place without any hardware and conceals the front cover mounting screws 1 Gently pry up the bottom edge of the cover with a flat blade screwdriver When there is a small gap between the bottom of the cover and raised edge above the control knob push the smoked cover upward and it will pop free from the unit Figure 3 1 Note lf removing the cover pushes the pliable gasket around the display out of position place it back into the gasket groove 2 Remove the two black nylon screws located by the speaker and fan vents in the bottom of the unit Figure 3 3 with a flat blade screwdriver Be careful not to cross thread the screws in reassembly 3 Remove the five mounting screws that secure the front panel with a Torx T 15 screwdriver Figure 3 2 4 Disconnect the display controls wire harness from the main PCB Figure 3 4 and remove the front panel wire harness connection Figure
21. istor thermocouple inserted into the delivery tube and allow the Precision Flow to attempt to clear the alarm If unsuccessful try a smaller diameter thermistor thermocouple 7 8 Adjust settings to 25 0 LPM 37 C and 21 Ox 7 9 When the temperature reaches 37C on the LED wait 5 minutes to allow temperature to stabilize and record temperature The unit is at 37 C when the temperature display is no longer flashing and the green light above the run stop button stops flashing 7 10 Actual temperature is to be 37 C 4 C 2 C RECORD READING When testing high temperatures outside of tightly controlled ambient conditions and or when using equipment with an accuracy less than what is recommended it is common to see measurements within the range indicated above The acceptance criteria for this test 37 C 4 C 2 C varies from the Precision Flow temperature performance specification of 2 C to account for variability in ambient conditions and test equipment 5 6 Technical Service Manual 3004005 Rev K PRECISION OV Section 5 Pre use Checklist 7 11 Test Complete Remove the High Flow DPC Eegiel 5 7 Technical Service Manual 3004005 Rev K PRECISION On 6 1 Tools amp Equipment Tools include the following Torx Drivers T 20 T 15 T 10 Small blade flat head screw driver set Small Philips screw driver set Diagonal Cutters Socket for encoder 11mm Equipment Electrical Safety Testing Equipment
22. ng Instructions Manual Section 8 Adjustments for additional information 2 4 Test Complete Remove the Low Flow DPC 3 High Flow DPC Recognition Test Duration Approximately 5 minutes 3 1 Install a High Flow DPC into the Precision Flow See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 3 2 Verify that The DWP icon is illuminated The General Cartridge Icons go out The High Flow Cartridge Icon is illuminated See Figure 5 1 for Icon Legend 3 3 Using the control knob verify The gas flow is adjustable from 5 L min to 40 L min 1 L min Resolution The oxygen percentage is adjustable from 21 to 100 1 Resolution The temperature range is adjustable from 33 to 43 G 1 C Resolution See the Precision Flow Operating Instructions Manual Section 8 Adjustments for additional information 3 4 Test Complete Remove the High Flow DPC If continuing on to step 4 leave the High Flow DPC inserted 5 2 Technical Service Manual 3004005 Rev K F PRECISION OW Section 5 Pre use Checklist 4 Air and Oxygen Inlet Pressure Recognition Test Duration Approximately 20 4 1 Install a High Flow DPC into the Precision Flow See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 4 2 Attach a sterile water bag to the spiked tube of the DPC and unclamp the spike tube clamp to allow the DPC to fill with water The Water O
23. o drop Silence alarm and wait for temperature to rise DWP Detecting the sensors Sensor detection clears GENERAL FAULT ALARMS Failures in the control or measurement systems for temperature gas flow and 2 3 oxygen percentage will cause a General Fault alarm indicated by this icon Unit will continue gas delivery in a fault condition until placed in Standby With the exception of O2 sensor replacement the unit must be repaired by an approved service facility General Fault alarms cannot be silenced with the mute button To reset first disconnect the unit from AC power and then press the Run Standby button 3004005 Rev K Technical Service Manual 2 4 PRECISION 0 Section 2 Troubleshooting Alarm Status Table System Display or Detection Reset Process Alarm General Fault Alarm amp Appears in Temp Contact Vapotherm Technical Support Display Pressure sensor 2 O2 out EN of range 02 Contact Vapotherm Technical Support Possible water ingress through gas supply contact Vapotherm Possible water ingress through gas supply contact Vapotherm Contact Vapotherm Technical Support Disconnect power amp press RUN button replace O2 sensor ar Pump tach out of range Contact Vapotherm Technical Support le Battery voltage below range Replace battery pack C ce EEN Ge 1 MEE s EA N pete ME es N er EN T epe eene E FONE or GEREED Restart the Unit if error code persists EE ra eee emeetvaponem Tec
24. on Flashes The light above the run stop button turns amber and flashes 6 9 Reconnect AC power 6 10 Verify The light above the run stop button turns green and stops flashing The Medium priority alarm is silenced The battery Icon may remain illuminated indicating that the battery is charging 6 11 Test Complete Remove the High Flow DPC If continuing on to step 7 leave the High Flow DPC inserted 7 Temperature Stability Check Duration Approximately 15 Minutes Equipment Required e RECOMMENDED Calibrated Omega HH 42 Digital Thermometer with an Omega Series 400 Thermistor Probe Omega PN ON 402 PP Accuracy of equipment may vary listed thermometer and thermistor have an accuracy of 0 015 C If using a different model you must consider the accuracy of the thermometer and thermocouple thermistor used For optimal results verify that the ambient temperature is 23 C 2 C 7 1 Clean the Precision Flow s sensor windows and heater plate with an alcohol swab CAUTION HEATER PLATE MAY BE EXTRMELY HOT Foreign matter on the heater plate surface or the sensor windows may impact the ability of the Precision Flow to reach set temperature See the Precision Flow Operating Instructions Manual Section 15 Cleaning and Disinfection for additional information 5 5 Technical Service Manual 3004005 Rev K PRECISION Ow Section 5 Pre use Checklist 7 2 Install a High Flow DPC into the Precision Flow V
25. on Test Duration Approximately 5 minutes 5 1 Install a High Flow DPC into the Precision Flow See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 5 2 Attach a sterile water bag to the spiked tube of the DPC and allow the DPC to fill with water The Water Out Icon may blink until the DPC has completely filled with water 5 3 Verify that the water bag icon goes dark lt may take up to 90 seconds for the DPC to completely fill with water and the Water Out Icon to clear 5 4 Adjust settings to 25 LPM 33 C 21 O and press the RUN button See the Precision Flow Operating Instructions Manual Section 8 Adjustments for additional information 5 5 Wait 30 seconds to allow flow to stabilize 5 6 Occlude the delivery tube by placing your thumb over the distal end of the delivery tube The precision Flow will attempt to restore flow every 3 seconds after an occlusion is detected Remove the occlusion to avoid consecutive alarms ME xun 5 7 Verify Flow stops The Medium priority alarm sounds The occluded tube icon flashes See Figure 5 1 for icon legend The precision Flow will attempt to restore flow every 3 seconds after an occlusion is detected Remove the xan xuz N SS occlusion to avoid consecutive alarms 5 8 Stop occluding the delivery tube by removing your thumb 5 9 Verrify that the alarm clears and that flow is restored 5 10 Test Complete Remove
26. ow LED above the Mute button indicates that one or more alarms are muted FLOW display in liters min OXYGEN Battery low or charging Disposable water path faulty or absei Low flow cartridge installed Blocked tub di Cartridge Water alarm out High flow General cartridge installed fault Gas supply absent TEMPERATURE display in C Figure 2 1 displays and icons ALARM TONE PRIORITIES e AE SEET alarms require immediate attention and are indicated by rapid intermittent tones fast triple beeps e LOW PRIORITY alarms require attention as soon as reasonably possible and are indicated by infrequent intermittent tones slow double beeps In addition to the medium and low alarms the Precision Flow emits the following audio signals e single dull tone that sounds when the unit switches from run to standby mode single high pitched beep whenever you press the control setting knob e low pitched buzz when you try to change a setting that cannot be changed or when alarm conditions prevent entering the run mode e slowly repeating single beep during disposable water path testing Technical Service Manual 3004005 Rev K 2 2 K f PRECISION OVWV Alarm Icons Table Section 2 Troubleshooting General fault flashing General fault flashing O2 displays dashes General fault flashing O2 amp LPM display dashes Temp Displays between 52 amp 84 Blocked tube flashing Wa
27. t outs in the control knob at panel before reassembling the Precision Flow unit VAPOTHERM Figure 3 13 front panel with display cover removed control board wire harness display PCB nut Encoder PCB Figure 3 14 front panel with control knob removed SE Figure 3 15 front panel rear view 3 4 Technical Service Manual 3004005 Rev K PRECISION OW Section 4 Preventative Maintenance 4 1 Regular Maintenance 4 1 1 Semi annual preventive maintenance It is recommended that the in line filters within both O2 and Air gas filter assemblies be replaced every 6 months or in accordance with your hospital maintenance records trends The part number for orders is 3003034 4 1 2 Annual preventive maintenance The oxygen sensor should be replaced annually The part number for the oxygen sensor is 300301 1 4 1 3 Bi annual preventive maintenance The internal battery pack should be replaced every 2 years as described in this manual in section 3 4 Replacing the batteries Perform the checkout procedure in section 5 before placing the unit back into service The part number for the battery pack is 3000064 NOTE The function of the battery pack is to bridge therapy for a short period of time in case of a loss of power to the unit It is NOT to be used to maintain unit function during patient transport Internal battery backup maintains flow and oxygen percentage for at least 15 minutes if AC power is cut off Batt
28. ter out flashing Disposable water path flashing Battery charging continuous Battery charging flashing Technical Service Manual Medium Priority Cannot be muted Medium Priority Cannot be muted Medium Priority Cannot be muted Medium Priority Mutes only during brief reset period Medium Priority Medium Priority Malfunction of sensor or control system O2 sensor fault General Fault Error Code High gas pres sure at inlet to delivery tube No water in disposable water path Gas flow continues without heating or water circulation Disposable water path faulty or not detected Unit will not run Internal component failure Depleted or defective O2 sensor bad 3 way solenoid valve or bad O2 sensor wire harness System Control Failure detected Obstructed or kinked cannula or delivery tube or incorrect cannula fitted for flow rate selected Sterile water empty or obstructed inlet tube Dispos able water path not assembled correctly defective not properly seated or not installed Stator not pumping properly First shut off unit for 30 seconds and restart If alarm does not clear disconnect patient Shut off unit send unit in for service Reset by shutting off unit Replace O2 sensor Restart unit Replace solenoid valve Replace O2 sensor wire harness See Table 2 5 General Fault Codes Clear obstruction check cannula type Only use Vapotherm cannula
29. the High Flow DPC If continuing on to step 6 leave the High Flow DPC inserted 6 Battery Backup Test Duration Approximately 10 minutes 6 1 Install a High Flow DPC into the Precision Flow See the Precision Flow Operating Instructions Manual Section 7 5 for additional information 6 2 Attach a sterile water bag to the spiked tube of the DPC and allow the DPC to fill with water The Water Out Icon may blink until the DPC has completely filled with water 6 3 Verify that the water bag icon goes dark lt may take up to 90 seconds for the DPC to completely fill with water and the Water Out Icon to clear 6 4 Adjust settings to 25 LPM 33 C 21 O and press the RUN button See the Precision Flow Operating Instructions Manual Section 8 Adjustments for additional information 6 5 Wait 30 seconds to allow flow to stabilize 5 4 Technical Service Manual 3004005 Rev K PRECISION OW Section 5 Pre use Checklist 6 6 Verify the Battery Icon is NOT illuminated The Battery Icon when illuminated signifies that the battery is not fully charged Please allow a minimum of 2 hours to fully charge the battery Disconnecting AC power while the Battery Icon is illuminated may cause the Precision Flow to power down 6 7 Disconnect AC power Failure to reconnect AC power within 15 minutes may result in shutdown of the Precision Flow 6 8 Verify Gas flow continues The Medium priority alarm is sounded The Battery Ic
30. ual 3004005 Rev K PRECISION OW CSA C 22 2 No 601 1 AS NZS 3200 1 2 EN60601 1 ISO 8185 ISO 11195 ISTA 2A gt lt ENVIRONMENTAL Operating Ambient temperature 18 30 C Ambient relative humidity 0 90 RH non condensing Ambient Pressure Standard atmospheric Not to be used in hyperbaric conditions Storage and Shipping Ambient temperature 10 50 C Ambient relative humidity 20 90 RH ALARM SOUND PRESSURE RANGES Medium Priority Alarm 47 dB measured 1m from unit Low Priority Alarm 45 dB measured 1m from unit 3004005 Rev K Section 1 General Information PRECISION OV Section 2 Troubleshooting 2 1 Alarms Fault conditions are indicated by icons displayed on the front panel and by audio signals see figure below e Unless indicated otherwise alarms will self clear when the fault condition is corrected e The MUTE button will silence low priority alarms for 2 minutes and medium priority alarms for 20 seconds except for Blocked Tube alarm which can only be muted for 5 seconds or less while the alarm resets General fault alarms cannot be muted e Gas flow continues during most alarm conditions except when the O2 supply gas pressure is outside specified range If supply gas pressure falls below setting an alarm sounds the bottle icon lights and flow display blinks Certain general fault conditions will halt flow see alarm status table at the end of this section for additional information A yell
31. upply 6 pin connector from J12 on the control PCB Disconnect ground wire and power entry module wire connections from power supply input connectors Do not disconnect hoses or unit will have to be recalibrated Technical Service Manual 3004005 Rev K F Section 3 Corrective Maintenance mounting screws pole clamp mounting screw Figure 3 5 rear cover screw es Wie SE side cover Figure 3 7 removing the side cover power supply mounting screws igure 3 8 back plate PRECISION OW 3 3 7 Remove the battery power supply assembly from the unit To remove the battery pack from the power Supply cut the two plastic cable ties that secure it to the power supply and disconnect its electrical connector J11 Figure 3 9 See Page 7 3 J11 connection Control PCB 8 Install the replacement battery pack or power supply assembly and reassemble the unit by reversing disassembly steps y H battery pack power supply PCB input connector Section 3 Corrective Maintenance Figure 3 9 power supply battery pack 3 5 Replacing the hinged door 1 To remove the door iirst remove the retaining clips from the grooved clevis pins and then remove the pins from the rear housing assembly Figures 3 10 amp 3 11 2 Attach the new door to the rear housing assembly by inserting the two grooved clevis pins in the hinges 3 Secure the clevis pins by attaching the ret
32. use block Tabs Figure 4 3 power cord inlet 4 2 4 Cleaning and disinfection The entire patient circuit is disposable and no disinfection is required The main unit including the docking station for the disposable water path should be wiped down with 70 90 isopropyl alcohol wipes after use The use of Hydrogen Peroxide solution concentration 6 maximum and Chlorine solution Sodium Hypochlorite concentration 2 maximum have been tested as well as the branded disinfecting detergent CaviwipesTM and Sani ClothTM AF3 Germicidal Wipes and have no adverse effects on the physical integrity or the functional capability of any of the components on the outer surface of the PF Unit NOTE The transparent sensor ports in the docking station must be clean The unit will not operate if the sensors do not receive a clear signal CAUTION Do not use bleach organic solvents or abrasive cleaners Use of solutions other than isopropyl alcohol may results in cracks in the housing 4 3 Technical Service Manual 3004005 Rev K PRECISION OV Section 5 Pre use Checklist Check V if VAPOTHERM PRECISION FLOW PRE USE CHECKLIST complete amp performance Is acceptable FLOW display in liters min Ox GEN G _ Battery low or Le charging Disposable water a path faulty or abse Law flow cartidge installed Blocked Cartridge Water He alarm SES High flow General cartidge installed fault dT Gas supply absent
33. ut Icon may blink until the DPC has completely filled with water 4 3 Verify that the water bag icon goes dark lt may take up to 90 seconds for the DPC to fill completely with water and the Water Out Icon to clear 4 4 Adjust settings to 25 LPM 33 C 21 O and press the RUN button See the Precision Flow Operating Instructions Manual Section 8 Adjustments for additional information 4 7 Verify Flow stops O2 displays LPM displays 0 5 L min Medium priority alarm sounds The gas tank icon flashes See Figure 5 1 for icon legend 4 8 Restore Air inlet pressure 4 9 Verify The alarm clears Flow and O2 are restored The gas tank icon goes dark See Figure 5 1 for icon legend 4 10 Adjust settings to 25 LPM 33 C 100 Ov ma 4 11 Wait 30 seconds to allow flow to stabilize ma 4 12 Turn off the Oxygen inlet pressure VD EE E E 4 13 Verify Flow stops O2 displays LPM displays 0 5 L min Medium priority alarm sounds The gas tank icon flashes See image in 4 7 and Figure 5 1 for icon legend 4 14 Restore Oxygen inlet pressure 4 15 Verify The alarm clears Flow and O2 are restored The gas tank icon goes dark See Figure 5 1 for icon legend 5 3 Technical Service Manual 3004005 Rev K PRECISION O WW Section 5 Pre use Checklist 4 16 Test Complete Remove the High Flow DPC If continuing on to step 5 leave the High Flow DPC inserted 5 Occlusi
34. wer cord 3003325 Israel power cord 3010182 Air hose assy yellow 3000035 O2 hose assy green 3000036 Heliox hose assy DISS 3200028 Smoked plex display cover 3000022 7 1 3004005 Rev K Section 7 Service Parts Technical Service Manual PRECISION OW Parts not shown Front panel CONTO in aas ee MM Z2 ZR2GQ 2MR 3000081 Control Knob Encoder 3000133 Mute button 3000011 Run Standby button 3003082 Door Precision Flow Hinged Door Kit 3010417 Internal alal oes ere ee Ee ee io 3000094 Wire Harness Speaker Fan Assy 3000076 Precision Flow Power Supply Insulator 30001 77 7 2 Technical Service Manual 3004005 Rev K Section 7 Service Parts
35. with needle nose pliers and pull straight back Access panel Unscrew the sensor body from its housing Insert new sensor and screw in Plug in cable and replace cover Do not over tighten screws Figure 4 2 sensor panel Apply label to indicate when replacement is due 6 Use the following chart to determine the age of the O2 sensor MAXTEC SERIAL NUMBER DEFINITION Maxtec Oxygen Sensor serial numbers are located on the oxygen sensor label The Lot Number Job Number Line Item Number and Sequence Number all relate to the sequence of when the sensor was manufactured during the month it was manufactured The model number is listed separately on the label LOT NUMBER LINE ITEM NUMBER JOB NUMBER SENSOR NUMBER IN THE LOT YEAR IN WHICH THE LAST 3 DIGITS ARE SEQUENTIAL NUMBERS LOT WAS STARTED STARTING FROM 1 V 2010 MONTH IN WHICH THE W 2011 X 2012 A ERN Y 2013 ik Z 2014 MAR A 2015 Han E MAY F JUN G JUL H AUG J SEPT K OCT L NOV M DEC Technical Service Manual 3004005 Rev K PRECISION OW Section 4 Preventative Maintenance 4 2 3 Fuse Replacement The mains fuses two GMA 3A F250 V 250V 5 x 20mm are located next to the power cord inlet Use two small flat blade screwdrivers to push the release clips on either end of the fuse block toward each other and release the fuse block to access the fuses Figures 4 3 and 4 4 i Fuses Fuse block Figure 4 4 f
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