R211P03 Maxventuri User Manual en
R211P03 Maxventuri User Manual en
E 50
D 40
C 30
B 20
A 10
02
MaxVenturi ®
R 2 11 P 0 3
R211M03 Rev. Q
Maxtec TEL (800) 748.5355
2305 South 1070 West FAX (801) 973.6090
Salt Lake City, Utah 84119 email: [email protected]
USA website: www.maxtec.com
Authorized Representative:
EC REP QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
CLASSIFICATION
Protection against electric shock: . . . . . . . . . . . . . . . . . . . . . . . . . . Internally powered equipment.
Protection against water: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX1
Mode of Operation: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous
Sterilization: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . See section 7.0
Flammable anesthetic mixture: . . . . . . . . . . . . . . . . . . . . . . . Not suitable for use in presence of a
flammable anesthetic mixture
WARRANTY
Provided the device is properly maintained and under normal operating conditions,
Maxtec warrants the MaxVenturi to be free from defects of workmanship or materials
for a period of 2 years from the date of shipment from Maxtec. Based on Maxtec’s
product evaluation, Maxtec’s sole obligation under the foregoing warranty is limited to
making replacements, repairs, or issuing credit for equipment found to be defective.
This warranty extends only to the buyer purchasing the equipment directly from Maxtec
or through Maxtec’s designated distributors and agents as new equipment.
Maxtec warrants the MAX-250E oxygen sensor in the MaxVenturi to be free from
defects in material and workmanship for a period of 2 years from Maxtec’s date of
shipment in a MaxVenturi unit. Should a sensor fail prematurely, the replacement
sensor is warranted for the remainder of the original sensor warranty period.
Routine maintenance items, such as batteries, are excluded from warranty. Maxtec
and any other subsidiaries shall not be liable to the purchaser or other persons for
incidental or consequential damages or for equipment that has been subject to abuse,
misuse, misapplication, alteration, negligence or accident.
These warranties are exclusive and in lieu of all other warranties, expressed or
implied, including warranty of merchantability and fitness for a particular purpose.
866.4.Maxtec www.maxtec.com I
WARNINGS !
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
» This device is not intended for use with life supporting devices/systems.
» Failure to comply with the warnings and precautions in this manual could result in
instrument damage and possibly jeopardize the wellbeing of the patient and/or health care
professional. Improper use of this device can cause inaccuracy of flow and oxygen readings
which can lead to improper treatment, hypoxia or hyperoxia, or other patient injury or
discomfort. Follow the procedures outlined in this user manual.
» Not for use in an MRI environment.
» If the O2% drifts away from the level to which it was set, check to make sure the nasal prongs
on the patient interface are not occluded by sputum or the nasal septum. Flow restriction to the
circuit or patient interface will cause the oxygen level to increase. Flow restriction downstream of
the venturi unit will not be detected by the flow meter.
» This device does not have any alarms for interruption in oxygen supply.
» Allow oxygen reading to stabilize before adjusting oxygen content.
» This device does not have any alarms for oxygen level high or low alarms.
» Never allow excess length of tubing near the patient’s head or neck which could result in strangulation.
» Use only Maxtec replacement sensors. Use of any other sensor will void warranty and may lead
to product damage, product malfunction, improper treatment to patient, hypoxia, or hyperoxia.
DO NOT use this device near any type of flame or flammable/explosive substances, vapors or
atmosphere. Operating the oxygen analyzer in these environments may result in fire or explosion.
» This device in its entirety (including electronics) is not suitable for use in the presence of
flammable anaesthetic mixtures or in an atmosphere of explosive gases. Operating the oxygen
analyzer in these environments may result in fire or explosion.
DO NOT attach a humidifier or any other source gas to the room air inlet. It should be occupied
at all times by the filter listed in the disposables list. The inlet filter prevents
entrainment of ambient contamination and silences venturi noise. The filter provided with the
MaxVenturi is single-patient use only.
» Use of this device with a pressurized oxygen bottle may result in inaccurate oxygen
concentration readings when used above 40 LPM and at high oxygen concentrations. High tank
pressures result in cooling oxygen supply temperatures which affect the accuracy of the oxygen
sensor. It is suggested that the device be connected with a long supply hose. Use a 15 ft supply
hose where possible — Maxtec P/N (R127P35).
» Use patient circuits that are approved for use with the manufacturer’s humidifier as listed in
their individual instructions for use.
DO NOT attempt to clean the inside of the flow meter. If any malfunction is detected in the
function of the flow meter, if any debris or contamination is detected in the flow meter, or if the float
sticks in the flow tube, discontinue use immediately and return the device to Maxtec for service.
» Never install the sensor in any location other than the sensor port in the device.
SENSOR WARNINGS: The Maxtec MAX-250 oxygen sensor is a sealed device containing a mild
acid electrolyte, lead (Pb), and lead acetate. Lead and lead acetate are hazardous waste constituents
and should be disposed of properly, or returned to Maxtec for proper disposal or recovery.
DO NOT use ethylene oxide sterilization.
DO NOT immerse the sensor in any cleaning solution, autoclave or expose the sensor to high
temperatures.
» Dropping or severely jarring the sensor after calibration may shift the calibration point enough to
require recalibration.
CAUTION: Indicates a potentially hazardous situation, if not avoided, could result in minor or
moderate injury and property damage.
» The MaxVenturi is intended for use with specific patient interface configurations. The numbered scale
is intended for use with Fisher & Paykel* heated humidifier (MR850) and the Optiflow high flow patient
interface system (OPT846, OPT570) and Comfort Flo® Circuits (2415 & 2416) with the Hudson RCI®
Neptune® Heated Humidifier (425-00). The lettered scale (Labeled A through F) is intended for the
alternate patient circuits found on the chart provided in Section 2.
II 866.4.Maxtec www.maxtec.com
» Never install the sensor in a location that will expose the sensor to patient exhalation or secretions.
» Only use Maxtec approved accessories and replacement parts. Failure to do so may seriously
impair the MaxVenturi’s performance. Repair or alteration of the MaxVenturi beyond the scope
of the maintenance instructions or by anyone other than authorized Maxtec service personnel
could cause the product to fail to perform as designed.
» Use of the MaxVenturi near devices that generate strong electrical fields may cause erratic readings.
» This device has a visual low-battery alarm but no audible alarm.
» Calibrate the MaxVenturi weekly when in operation or if environmental conditions change significantly,
i.e., Temperature, Humidity, Barometric Pressure. (refer to Calibration sections of this manual).
» The device will assume a percent oxygen concentration when calibrating. Be sure to apply
100% oxygen or room air concentration to the device during calibration or the device will not
calibrate correctly. (See section 2.2)
DO NOT use ethylene oxide sterilization. DO NOT immerse the device in any cleaning solution,
autoclave or expose the device to high temperatures.
» Use with any other patient interface system may result in false readings from the flow meter.
» The MaxVenturi is not intended for steam, ethylene oxide or radiation sterilization.
DO NOT clean with ethanol or acetone.
» After cleaning, and before use on a patient, attach the device to an oxygen supply and allow the
device to run at high flow for several minutes to allow any cleaning fluids or vapors to evaporate
and be flushed out.
» The device can flow excess oxygen out the entrainment port if the oxygen control knob is
turned up too high. This can lead to a minor drop in total air flow to the patient and excess
oxygen entering the room environment.
» Federal Law (USA) restricts this device to sale by or on the order of a physician.
ATTENTION: Indicates a potentially hazardous situation, if not avoided, could result in minor or
moderate injury and property damage.
» If the MaxVenturi is ever exposed to liquids (spills or immersion) or to any other physical abuse,
return to Maxtec for evaluation before use.
» Always remove the batteries to protect the unit from potential leaky battery damage when the
unit is going to be stored or not in use for periods exceeding 1 month. Replace dead batteries
with high quality AA Alkaline batteries.
DO NOT use rechargeable batteries with this device.
» Maxtec cannot warranty any damage resulting from misuse, unauthorized repair or improper
maintenance of the instrument.
» This product is Latex free.
» Avoid usage in environments with greater than 95% relative humidity.
IV 866.4.Maxtec www.maxtec.com
1.0 SYSTEM OVERVIEW
1.1 Component Identification
10
60
11 50
40
12
30
13 20
10
14 O2
9 8
866.4.Maxtec www.maxtec.com 1
1.2 Symbol Guide
The following symbols and safety labels are found on the MaxVenturi:
only Federal Law (USA) restricts this device to LOT Lot code/Batch code
sale by or on the order of a physician
2 866.4.Maxtec www.maxtec.com
2.0 SET-UP INSTRUCTIONS
2.1 Sensor Installation
1 2 3
...30-90 Minutes
4 5 6
Attach sensor to sensor Press and hold CAL button Insert sensor into port on
cable. for three (3) seconds. MaxVenturi.
Wait for display to read
"20.9%".
2.2 Calibration
A new calibration is required when:
» The measured O2 percentage in 100% O2 is below 97.0%.
» The measured O2 percentage in 100% O2 is above 103.0%.
» The CAL reminder icon is blinking at the bottom of the LCD.
» You are unsure about the displayed O2 percentage, see Factors Influencing Accurate
Readings in section 3.0.
The MaxVenturi can be calibrated at 100% oxygen or room oxygen (20.9%).
The One Touch calibration will assume one of these two concentrations.
866.4.Maxtec www.maxtec.com 3
2.2.1 Room Air Calibration
CAUTION: Turn off all flow of gas to the MaxVenturi before calibration in room air.
Calibrating the oxygen sensor in a gas concentration other than room air (20.9%) will result
in an incorrect measurement of oxygen concentration.
1 2 2
...2 Minutes
Shut off Oxygen supply. Remove sensor from port. Wait two (2) minutesfor
sensor to equilibratein
room air.
5 6
1 2 3
Connect Oxygen supply. Plug room air inlet. Turn ON/OFF valve to
the ON position.
4 5 6
4 866.4.Maxtec www.maxtec.com
4 5 6
...2 Minutes
Turn flow knob a few Wait 2 minutes for Press and hold CAL
turns to flow gas. sensor to equilibrate. button for three (3)
seconds. Wait for display
to read 100%.
7 8
NOTE: Analyzer will read "Cal Err St" if the sample gas is not stable or if the oxygen
sensor has reached its end of life.
2.3 Device Set-up
1 2 3
4 5
866.4.Maxtec www.maxtec.com 5
4 5
1
Attach patient circuit to Turn ON/OFF valve to on
MaxVenturi outlet. position.
1 1 2 2 3
Adjust flow to desired Set desired oxygen mixture Adjust flow if it has
setting and read flow by opening O2% knob and changed.
meter. read analyzer.
3 3
1 1 2 2
Adjust flow to new desired flow rate. Readjust oxygen concentration to desired
setting and wait for analyzer to equilibrate.
Temporarily disconnect patient circuit if
necessary.
3 3
6 866.4.Maxtec www.maxtec.com
2.4.3 Changing Oxygen Settings
1 1 2 2
Adjust O2% knob to desired level and Verify flow rate has not changed and
wait for analyzer to equilibrate.Temporarily adjust if necessary.
disconnect patient circuit if necessary.
! Warning: Adjusting the oxygen setting too high at low flows may cause
oxygen to exit the air inlet port. Verify the direction of flow by placing your
hand under the air filter to feel for air escape.
2.5 Disposables
The MaxVenturi for is intended for use with approved disposables. Several patient
delivery circuits and patient interfaces have been tested and approved for use with
the MaxVenturi. The approved delivery circuits and patient interfaces are:
2.5.1 Disposable Patient Circuits
» Fisher & Paykel single heated limb circuit (RT202) with humidifier chamber (MR290).
» Airlife single heated limb circuit (RT600-850) with humidifier chamber (MR290).
» Standard 6', 22mm corrugated tube (Airlife 001450 or similar. Not humidified).
» Comfort Flo® Circuits (2415 & 2416) with the ConchaSmart® Column (382-10).
2.5.2 Disposable Patient Interfaces
» Optiflow large nasal cannula (Fisher & Paykel OPT544).
» Optiflow medium nasal cannula (Fisher & Paykel OPT846).
» Optiflow Tracheostomy direct connection (Fisher & Paykel OPT570).
» Pediatric aerosol mask with 22mm inlet (Airlife 001263 or similar).
» Adult aerosol mask (Airlife 001206 or similar).
» Trach adaptor T-piece (Airlife 001500 or similar).
» Tracheostomy mask with 22mm inlet - loose fitting (Airlife 001225 or similar).
» Hudson RCI® Trach-Flex™ PlusTracheostomy Adapter (2415-01).
» Hudson RCI® Comfort Flo® Plus Cannula - Large (2412-11).
» Hudson RCI® Comfort Flo® Plus Cannula - Medium (2412-12).
» Hudson RCI® Comfort Flo® Plus Cannula - Small (2412-13).
CAUTION: Use of patient circuits or patient interfaces other than these constitutes
"off- label use". This can result in device malfunction or harm to the patient.
The delivery circuit can be paired with the patient interface circuits listed in
the table below:
866.4.Maxtec www.maxtec.com 7
TABLE INSTRUCTIONS: To determine the desired flow, locate the patient
delivery circuit and interface in the two left-hand columns. Find the
corresponding flow rate by reading to the right under columns A through F.
The lettered columns correspond to the lettered graduations on the flow meter.
CAUTION: The flow rates listed in this table are the result of bench testing the MaxVenturi
on the indicated patient circuits and interfaces. Actual flows may vary in clinical use
depending on patients physiology, breathing rate and other factors listed in Section 3.0.
Interface Patient
Hudson RCI® Trach-Flex™ Plus Tracheostomy Adaptor (2415-01)
F&P Humidifier with 22mm
Single Heated Limb Circuit
Interface Patient
Hudson RCI® Trach-Flex™ Plus Tracheostomy Adaptor (2415-01)
6' - 22mm Corrugated
Interface Patient
Hudson RCI® Trach-Flex™ Plus Tracheostomy Adaptor (2415-01)
ConchaSmart™ Technology
Hudson RCI® Neptune®
Humidification Circuit
NOTE: For the Comfort Flo Humidification System, a section of 22mm tubing is used to
connect the outlet of the MaxVenturi to the inlet of the humidification chamber in place
of the supplied pressure relief valve.
8 866.4.Maxtec www.maxtec.com
2.5.3 Inlet Filter
» Air Safety Ltd. Cat.No. RP34P02
866.4.Maxtec www.maxtec.com 9
CAL Err hi: SENSOR VOLTAGE TOO HIGH
» Repeat calibration routine as described in this manual. If unit repeats this error more
than three (3) times, contact Maxtec Customer Service.
CAL Err Bat: BATTERY VOLTAGE TOO LOW TO RECALIBRATE
» Replace batteries.
Turn off analyzer. Use screwdriver to Pull front cover off away
remove four (4) screws from unit.
in back of device.
4 5 6
7 8 9
10 866.4.Maxtec www.maxtec.com
6.0 CHANGING THE OXYGEN SENSOR
1 2 3
NOTE: For new sensor installation, follow procedure for new sensor installation in section 2.1.
866.4.Maxtec www.maxtec.com 11
8.0 SPECIFICATIONS
8.1 Analyzer Specifications
Measurement Range: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-100%
Resolution: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1%
Accuracy and Linearity: . . . . . . . . . . . . . . . . . . 1% of full scale at constant temperature, R.H. and
pressure when calibrated at full scale
Total Accuracy: . . . . . . . . . . . . . . . . . . . . . ±3% actual oxygen level over full operating temp range
Response Time: . . . . . . . . . . . . . . . . . . . . 90% of final value in approximately 15 seconds at 23˚C
Warm-up Time: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . None required
Operating Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15˚C - 40˚C (59˚F - 104˚F)
Storage Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -15˚C - 50˚C (5˚F - 122˚F)
Atmospheric Pressure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 800-1013 mBars
Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-95% (non-condensing)
Power Requirements: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 AA Alkaline batteries (2 x 1.5 Volts)
Battery Life: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approximately 5000 hours with continuous use
Low Battery Indication: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "BAT" icon displayed on LCD
Sensor Type: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maxtec MAX-250 series galvanic fuel cell
Expected Sensor Life: . . . . . . . . . . . . . . . . . . . . . . . . . . > 1,500,000 O2 percent hours minimum
(2-year in typical medical applications)
Dimensions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3 x 6.6 x 5.3 (185mm x 167mm x 135mm)
Weight: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.54 ibs (1.15kg)
Drift of Measurement: . . . . . . < +/-1% of full scale at constant temperature, pressure and humidity
10 ±33%
Operating Range
20 ±18%
30 ±15%
40 ±11%
50 ±11%
60 ±9%
12 866.4.Maxtec www.maxtec.com
8.3 Oxygen Inlet Supply
This device was designed for an oxygen inlet pressure of 3.5 bar (50psi).
Certain geographical areas use 4 bar (58psi) or 5bar (73psi) as the standard
piped oxygen distribution pressure. This device can be operated at these
pressures but the flow readings on the flow meter must be corrected for the
additional pressure. The table below gives correction factors for each flow
meter graduation indicating the percent increase in flow from nominal that will
result due to the increased inlet pressure at 4bar and 5bar.
Nominal Flow 4 Bar 5 Bar
LPM (% increase) (% increase)
10 - A 13 34
20 - B 9 24
30 - C 7 18
40 - D 6 16
50 - E 5 13
60 - F 4 12
866.4.Maxtec www.maxtec.com 13
10.0 TROUBLESHOOTING
Problem: The flow does not reach 55LPM even with the flow valve wide open.
Possible Cause: The pressure of your piped oxygen supply in your hospital
may be low. Also check to see if the float in the flow meter is sticking. Tip the
unit back and forth. Ball should roll freely. If it seems to stick or hesitate, return
the unit to Maxtec for service. If you cannot detect the problem, contact the
Maxtec Service Department by calling the number listed in this manual. Do not
disassemble the device to try to detect an internal problem.
Problem: The oxygen level on the display does not reach 100%, even with the
oxygen control knob fully open.
Possible Cause: Check if the device needs to be calibrated. If you wish to
use the device at oxygen concentrations closer to 100% oxygen, it is best to
calibrate the device at 100% oxygen. Refer to the calibration section in this
manual and follow the 100% oxygen calibration routine. If this does not solve
the problem, contact the Maxtec Service Department.
Problem: The oxygen level displayed does not go as low as the level indicated
in the specifications, even with the oxygen control knob completely closed.
Possible Cause: It is very likely the device needs to be calibrated. Also check
to make sure the humidifier and patient delivery disposables are the correct
size and installed correctly with no kinking or occlusion. Check the air inlet
filter for moisture or dirt - replace if necessary. Valve cartridges may be worn;
perform leak test according to preventative maintenance procedure.
Requires only an oxygen supply Requires both oxygen and medical air supply
14 866.4.Maxtec www.maxtec.com