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Summary of Contents for Baylis V4C-O2E
- Page 1 User Manual Baylis Medical V4C-O2E™ Oxygen Mixer DMR V4C 3.3 (User Manual) V-4 06-May-2022...
- Page 2 The customer shall obtain a return authorization number before shipping the Unit back. Baylis Medical at its sole discretion can repair the Unit or ship a new one. The Units are to be shipped freight pre-paid for both the warranty period and out of warranty.
- Page 3 Purchaser specifically agrees that Baylis Medical shall not be liable for damages, personal injury or death if the Equipment is used with any unauthorized products, items, consumables, disposables, equipment, and parts. Purchaser specifically agrees that Baylis Medical shall not indemnify the Buyer for claims resulting in damages, personal injury or death if the Equipment is used with any unauthorized products, items, consumables, disposables, equipment and parts.
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Page 4: Table Of Contents
Table of Contents Preface Purpose of This Manual ............-ix Qualification of Personnel . - Page 5 ... . . 5-7 Stopping Ventilation While Using the V4C-O2E Oxygen Mixer ....5-8 Using the Compatible Ventilator Without the V4C-O2E Oxygen Mixer .
- Page 6 Figure 2-2. V4C-O2E Oxygen Mixer features on the front and back panels ......2-5 Figure 4-1. ...
- Page 7 Part numbers................10-1 Table 11-1. Parts and accessories provided with the V4C-O2E Oxygen Mixer ......11-2 Table 12-1. ...
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Page 8: Purpose Of This Manual
It is essential to read, understand and follow these instructions before using the V4C-O2E Oxygen Mixer. In order to use the V4C-O2E Oxygen Mixer correctly and efficiently and to help prevent inci- dents, please pay particular attention to Section 1.2, Warnings, as well as all warnings and cautions contained throughout this manual. -
Page 9: Manufacturer
Preface Manufacturer Baylis Medical Technologies 2645 Matheson Blvd. East Mississauga, Ontario Canada L4W 5S4 [T] +1 (905) 948-5800 User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 10: Safety Information
Note Indicates points of particular emphasis, that make operation of the ventilator more efficient or convenient. It is essential to read, understand and follow these instructions before using the V4C-O2E Oxygen Mixer. In order to use the Oxygen Mixer correctly and efficiently and to help prevent incidents, please pay particular attention to section 1.2, Warnings, as well as all warnings and cautions contained... - Page 11 Oxygen Mixer, call for maintenance. WARNING: If at any time a leak is suspected from or inside the V4C-O2E Oxygen Mixer, terminate use and call for maintenance. Excessive oxygen consumption may be indicative of a leak. User Manual...
- Page 12 Mixer. WARNING: Battery capacity of the V4C-560 Ventilator may be affected by use with the V4C-O2E Oxygen Mixer and therefore values may differ from those in the manual of the compatible ventilator. Refer to the values in Section 2.9,...
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Page 13: Warnings Regarding Installation And Accessories
WARNING: Do not use V4C-O2E Oxygen Mixer with ventilators that are missing rubber feet. If a ventilator is missing any of its rubber feet, see instructions in Section 4.1, Installation and Assembly on how to install replacement feet which are supplied with the V4C-O2E Oxygen Mixer. - Page 14 Warnings WARNING: Do not use the V4C-O2E Oxygen Mixer if it is not appropriately affixed to the ventilator. See Section 4.1, Installation and Assembly for instructions on how to securely attach the V4C-O2E Oxygen Mixer to the ventilator. ...
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Page 15: Fio2 Readings And Calibration
WARNING: Do not cover the V4C-O2E Oxygen Mixer or place it in a position that affects proper operation, including close to a heat source, on an uneven surface, or on a bed. User Manual... -
Page 16: Warnings Regarding Oxygen Supply
WARNING: To avoid injury to the patient and/or possible damage to the V4C-O2E Oxygen Mixer: before using the V4C-O2E Oxygen Mixer, use appropriate equipment to regulate the oxygen supply to specifications before connecting the V4C-O2E Oxygen Mixer to the oxygen supply. -
Page 17: Warnings Regarding Alarms And Troubleshooting
WARNING: Oxygen flow to the ventilation system will begin automatically when an active breathing mode is selected. The V4C-O2E Oxygen Mixer will terminate oxygen flow when the ventilator is not in an active breathing mode. WARNING: In the event of power loss to the ventilator, oxygen delivery to the Oxygen Mixer will cease immediately. -
Page 18: Warnings On Storage And Maintenance
(this is to prevent dust from entering the gas pathway). If the V4C-O2E Oxygen Mixer is stored without the ventilator, it is recommended that it be stored in a bag or a box (preferably its original packaging) to ensure no dust or debris enter and contaminate the mixer. -
Page 19: Warnings Regarding Filters
WARNING: Check the condition of the V4C-O2E Oxygen Mixer's air intake filter once a month when used indoors. If the V4C-O2E Oxygen Mixer is used outdoors or in a dusty environment, the Oxygen Mixer's air intake filter should be checked weekly and replaced as necessary. Do not wash or wet the filter as this may compromise its filtration or resistance. -
Page 20: Symbols And Labels
This label appears on the Oxygen Mixer’s air intake. Air exhaust, do not obstruct. It is essential to read, understand, and follow these instructions before using the V4C-O2E Oxygen Mixer (ISO 7000-0434A). This symbol appears on the V4C-O2E Oxygen Mixer's back panel. - Page 21 Specifications for specifications. Catalogue number. Index of Protection rating for the V4C-O2E Oxygen Mixer's enclosure, defined in IEC 60529. This symbol appears on the V4C-O2E Oxygen Mixer's back panel. O2E port. This symbol appears on the V4C-O2E Oxygen Mixer's back panel.
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Page 22: Table 1-2. V4C-O2E Oxygen Mixer Labels And Markings
Symbols and Labels Table 1-2. V4C-O2E Oxygen Mixer labels and markings Label or Marking Description 1. Do not obstruct label. 2. O pressure info label. 3. General info label. 4. O2E port marking. 5. O inlet marking. 6. Baylis address label. 7. TÜV SÜD certification marking label. -
Page 23: Figure 1-1. Location Of Labels - Rear View
Safety Information Figure 1-1. Location of labels — rear view Figure 1-2. Location of labels — bottom view Figure 1-3. Location of labels — side view 1-14 User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 24: Overview
WARNING: Improper use of the V4C-O2E Oxygen Mixer, failure of the device, or failure to deliver oxygen can result in patient injury or death. Always follow instructions in this manual and that of the compatible ventilator, and always monitor the patient. -
Page 25: Indications For Use
To reduce the risk of infection, wash your hands thoroughly before and after handling the Oxygen Mixer or its accessories. WARNING: Do not expose the V4C-O2E Oxygen Mixer to direct sunlight for prolonged periods of time. WARNING: Avoid using the V4C-O2E Oxygen Mixer, if possible, in dusty environments. Dusty environments may require more vigilant monitoring, cleaning, and/or replacement of air intake filter and other filters. -
Page 26: Target Operators
Patient and patient’s families • Contraindications The V4C-O2E Oxygen Mixer is not for use with anesthetic gases, and is not intended for use during emergency transport. Operational Use The V4C-O2E Oxygen Mixer can be used with compatible ventilators to expand the range of oxygen concentrations which can be delivered to the patient up to 100%. -
Page 27: Operating Parameters
Overview Figure 2-1. O2E port on the V4C-560 Ventilator Operating Parameters When used with the V4C-560 Ventilator, the compatible ventilator can deliver 21-100% FiO air- oxygen mixtures. Table 2-1. FiO specifications range* 21-100% Response time to change in FiO setting from 21% to 90% O <30 s (measured at the patient wye). -
Page 28: Device Features
Device Features Device Features Figure 2-2. V4C-O2E Oxygen Mixer features on the front and back panels Table 2-2. Figure 2-2 legend Call-out Feature Description Number Used in conjunction with an external FiO monitor to adjust the delivered FiO2 adjustment knob oxygen concentration. V4C-O2E Oxygen Mixer adhe-... -
Page 29: Specifications
Maximum allowable flow resistance when using the Oxygen Inspiratory bacteria filter requirements Mixer: Adult: 2.9 cmH2O at 60 lpm Pediatric: 3.0 cmH2O at 30 lpm See Baylis Medical V4C-O2E Air Intake Filter (HW01XXXXFMINT) V4C-O2E Oxygen Mixer air intake filter in Section 11, Unpacking and Accessories. -
Page 30: Battery Capacity
(primarily in terms of temperature) and the physiological char- acteristics of the patient. Use of the V4C-O2E Oxygen Mixer may alter the reserve capacity of the compatible ventilator from those in the manual of the compatible ventilator. -
Page 31: If Failure Occurs
Refer to Section 3, Alarms and Troubleshooting. If you cannot deter- mine the cause of a problem, contact your equipment supplier or Baylis Medical Technologies. User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 32: Alarms And Troubleshooting
WARNING: This manual tells you how to respond to and troubleshoot issues with the V4C-O2E Oxygen Mixer, but it does NOT tell you how to respond to the patient. Always examine the patient first before examining the ventilator and Oxygen Mixer. -
Page 33: Troubleshooting Overview
WARNING: Do not attempt to open, repair or otherwise service the V4C-O2E Oxygen Mixer yourself. Doing so might endanger the patient, damage the Oxygen Mixer, and/or void your warranty. Only personnel authorized and qualified by Baylis Medical Technologies should repair, open or service the V4C-O2E Oxygen Mixer. -
Page 34: Table 3-1. V4C-O2E Oxygen Mixer Troubleshooting
FiO See section 2.5, Operating Parameters further information. If fault does not clear, discontinue use of the V4C-O2E Oxygen Mixer. Contact your customer service representative for assis- tance. User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... - Page 35 Confirm that no oxygen is being deliv- ered to the low pressure oxygen inlet of the compatible ventilator. Delivering oxygen directly to the ventilator while using the V4C-O2E Oxygen Mixer will impact FiO percentage delivered to the patient. If fault doesn't clear, discontinue use of the V4C-O2E Oxygen Mixer.
- Page 36 Alarm Message or Symptom Possible Reason for the Event Corrective Action Knob unresponsive Loose connection. Inspect the V4C-O2E Oxygen Mixer for signs of damage. Discontinue use if any Internal technical fault. damage is identified and contact your customer service representative for assis- tance.
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Page 37: Installation And Assembly
O2E Oxygen Mixer. Cooling vents located in this space may become compromised. WARNING: Do not use the V4C-O2E Oxygen Mixer if it is not appropriately affixed to the ventilator. See Section 4.1, Installation and Assembly for instructions on how to securely attach the V4C-O2E Oxygen Mixer to the ventilator. - Page 38 The V4C-O2E Oxygen Mixer must not be used with flammable anesthetic substances. WARNING: Do not use V4C-O2E Oxygen Mixer with ventilators that are missing rubber feet. If a ventilator is missing any of its rubber feet, see instructions in Section 4.1, Installation and Assembly on how to install replacement feet which are supplied with the V4C-O2E Oxygen Mixer.
- Page 39 To assemble the ventilator and Oxygen Mixer: Refer to Figure 4-1 and Figure 4-2. Use the installation tool to attach the side arms to the V4C-O2E Oxygen Mixer enclosure with four M6 screws and four M6 washers, until fully secured.
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Page 40: Figure 4-1. Attaching The First Side Arm
Installation and Assembly Figure 4-1. Attaching the first side arm Figure 4-2. Attaching the second side arm Caution: Never rest the Oxygen Mixer on its back face or on the oxygen inlet module. Take care when maneuvering the device not to knock the oxygen inlet module on the table or another object. User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 41: Figure 4-3. Compatible Ventilator Feet Location
Refer to Figure 4-4 and Figure 4-5. Bend the side arms out and lower the compatible ventilator onto the V4C-O2E Oxygen Mixer. Make sure that the posts on the V4C-O2E Oxygen Mixer are aligned with the compatible ventilator and that the ventilator's feet are positioned inside of the corresponding recesses on the Oxygen Mixer's top surface. -
Page 42: Figure 4-5. Lowering The Compatible Ventilator Onto The V4C-O2E Oxygen Mixer
Figure 4-5. Lowering the compatible ventilator onto the V4C-O2E Oxygen Mixer Refer to Figure 4-6. Lower the handle on to the side arms with the Baylis Medical logo facing the front (the straight face of the handle is facing forward). Press down firmly to secure the handle. Install 2 M6 screws and 2 M6 washers as shown. -
Page 43: Figure 4-6. Installing The Handle
Figure 4-7. Gas connection tube adapter installed on the gas connection tube Refer to Figure 4-8 and Figure 4-9. Install the gas connection tube (1) to the V4C-O2E Oxygen Mixer air outlet and the gas connection tube adapter to the compatible ventilator's air inlet. Ensure it is not pinched or kinked along its length. -
Page 44: Figure 4-8. Installing V4C-O2E Oxygen Mixer Connections And Air Intake Filter
Installation and Assembly Figure 4-8. Installing V4C-O2E Oxygen Mixer connections and air intake filter Table 4-1. Figure 4-8 legend Call-out Description Number Gas connection tube O2E electrical connecting cable Air intake filter Oxygen hose connection Figure 4-9. Gas connection tube and adapter connected to the ventilator User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 45: Figure 4-10. Confirming No Filter Is Installed On The Back Of The V4C-560 Ventilator
Installation and Assembly Figure 4-10. Confirming no filter is installed on the back of the V4C-560 Ventilator User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 46: Figure 4-11. Red Markings On The Electrical Cable And O2E Port
Refer to Figure 4-8. Install the O2E electrical connecting cable (2) from the compatible ventilator O2E port to the V4C-O2E Oxygen Mixer. Refer to Figure 4-11. When connecting the cable, line up the red marking on the cable’s connector with the red marked notch on the O2E port to ensure the correct orientation. -
Page 47: Disassembly
(this is to prevent dust from entering the gas pathway). If the V4C-O2E Oxygen Mixer is stored without the ventilator, it is recommended that it be stored in a bag or a box (preferably its original packaging) to ensure no dust or debris enter and contaminate the mixer. - Page 48 Ensure the appropriate filter is re-installed on the back of the ventilator's air intake before initiating use of the ventilator without the V4C-O2E Oxygen Mixer. For more information on filter type and assembly consult the manual of the compatible ventilator.
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Page 49: Operating Procedures
Oxygen Mixer, call for maintenance. WARNING: If at any time a leak is suspected from or inside the V4C-O2E Oxygen Mixer, terminate use and call for maintenance. Excessive oxygen consumption may be indicative of a leak. ... - Page 50 Before starting ventilation, ensure that the device is properly assembled and confirm that the Oxygen Mixer’s air intake port and vents are not obstructed. WARNING: Do not use unauthorized accessories with the V4C-O2E Oxygen Mixer system. Use of incorrect accessories can lead to malfunction or damage to the device. WARNING: Do not place anything in the space between the bottom of the ventilator and the top of the V4C- O2E Oxygen Mixer.
- Page 51 WARNING: Do not cover the V4C-O2E Oxygen Mixer or place it in a position that affects proper operation, including close to a heat source, on an uneven surface, or on a bed. ...
- Page 52 WARNING: To avoid injury to the patient and/or possible damage to the V4C-O2E Oxygen Mixer: before using the V4C-O2E Oxygen Mixer, use appropriate equipment to regulate the oxygen supply to specifications before connecting the V4C-O2E Oxygen Mixer to the oxygen supply.
- Page 53 Sensor Calibration WARNING: Never use the V4C-O2E Oxygen Mixer without appropriately setting both high and low pressure/ volume alarms on the compatible ventilator. WARNING: Do not use the V4C-O2E Oxygen Mixer without an inspiratory bacterial filter between the ventilator's outlet and the patient.
- Page 54 Operating Procedures Set the desired FiO using the adjustment knob. After a minimum of 1 hour of ventilation, recalibrate the sensor as described below. Caution: During the warm up period the FiO readings may drift and the reading may no longer be accurate.
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Page 55: Fio 2 Sensor Calibration
FiO Caution: Turning the knob with excess force past the usable limit may damage the V4C-O2E Oxygen Mixer. Stop turning when resistance is felt. Note: The two extremes of the knob position may yield little to no FiO changes, while the centre of the knob will have the highest sensitivity to change. -
Page 56: Stopping Ventilation While Using The V4C-O2E Oxygen Mixer
Mixer WARNING: Turn off or disconnect oxygen supply when the V4C-O2E Oxygen Mixer is not in use. Confirm that a patient is not connected to the compatible ventilator. Stop ventilation as per the compatible ventilator's manual. Using the Compatible Ventilator Without the V4C-O2E Oxygen Mixer The compatible ventilator can be used without removing it from the Oxygen Mixer's handles. -
Page 57: Cleaning
Squeeze the cloth thoroughly to remove excess liquid. Lightly wipe the external casing of the V4C-O2E Oxygen Mixer, taking care not to allow excess mois- ture to enter any of the openings on the V4C-O2E Oxygen Mixer's surface or the Oxygen Mixer air intake filter. -
Page 58: Table 6-1. Approved Cleaning Solutions For Exterior Oxygen Mixer Surfaces
Lightly wipe the electrical connecting cable and the outside of the gas connection tube. Take care not to allow cleaning solutions to enter the tubing. Dry the V4C-O2E Oxygen Mixer surface and its accessories with a clean, soft, lint-free cloth. Table 6-1. Approved cleaning solutions for exterior Oxygen Mixer surfaces... -
Page 59: Routine Maintenance
WARNING: Check the condition of the V4C-O2E Oxygen Mixer's air intake filter once a month when used indoors. If the V4C-O2E Oxygen Mixer is used outdoors or in a dusty environment, the Oxygen Mixer's air intake filter should be checked weekly and replaced as necessary. Do not wash or wet the filter as this may compromise its filtration or resistance. -
Page 60: Figure 7-1. V4C-O2E Air Intake Filter Location
Clean the ventilator per Chapter 6. Clean all external panels and surfaces before and after each patient use and as often as necessary to keep the V4C-O2E Oxygen Mixer clean. You should clean the ventilator and Oxygen Mixer periodically, whenever it is soiled or dirty, before any maintenance operation, and before storing the device. -
Page 61: Theory Of Operation
8 Theory of Operation The V4C-O2E Oxygen Mixer is primarily composed of a pressure controlled proportional sole- noid, which actively controls the pressure of the incoming oxygen over the course of a delivered breath, and a mixing valve which can be used to adjust the proportion of air and oxygen deliv- ered to the ventilator. -
Page 62: Figure 8-2. Internal Function Of The Mixing Valve
Theory of Operation Figure 8-2. Internal function of the mixing valve Figure 8-3 shows the shape of the curve of the FiO percentage as a function of knob position. Figure 8-3. The FiO % output as a function of the knob’s position User Manual DMR V4C 3.3 (User Manual) V-4 06-May-2022... -
Page 63: Operational Verification Checklist And Functional Testing
WARNING: Do not use the V4C-O2E Oxygen Mixer if it is not appropriately affixed to the ventilator. See Section 4.1, Installation and Assembly for instructions on how to securely attach the V4C-O2E Oxygen Mixer to the ventilator. - Page 64 See Section 5.1, Sensor Calibration calibration instructions. WARNING: Never use the V4C-O2E Oxygen Mixer without appropriately setting both high and low FiO alarms on the compatible ventilator or FiO monitor. ...
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Page 65: Functional Tests
Oxygen Mixer, call for maintenance. WARNING: If at any time a leak is suspected from or inside the V4C-O2E Oxygen Mixer, terminate use and call for maintenance. Excessive oxygen consumption may be indicative of a leak. ... -
Page 66: Test 1 - Compatible Ventilator Alarms Test
Test 1 — Compatible Ventilator Alarms Test 9.2.1 Complete all tests in the compatible ventilator's manual with the V4C-O2E Oxygen Mixer con- nected. For the V4C-560 Ventilator, follow Clinician's Manual Section F - Alarms Tests. Confirm all alarms tests pass. -
Page 67: Test 3 - Low Fio2 Test
Test 9.2.3 To perform a Low FiO test, do the following: Ensure V4C-O2E Oxygen Mixer is installed per Section 4.1, Installation and Assembly. Ensure the venti- lator is set-up per its instruction manual. Run this test with an ADULT patient limb. Connect the patient end of the patient circuit to a test lung. -
Page 68: Test 4 - Fio2 Alarms Test
Alarms Test 9.2.4 To perform an FiO Alarms Test, do the following: Ensure V4C-O2E Oxygen Mixer is installed per Section 4.1, Installation and Assembly. Ensure the venti- lator is set-up per its instruction manual. Connect the patient end of the patient circuit to a test lung. -
Page 69: Part Numbers
Doing so may increase circuit resistance and compromise spontaneous breathing. For information on allowable filter resistances see Section 2.7, Specifications. Table 10-1 provides a list of accessories that are required for use of the V4C-O2E Oxygen Mixer. To order parts or accessories, contact your equipment supplier or Baylis Medical Technologies representative. -
Page 70: Unpacking And Accessories
Contact Baylis Medical Technologies if the cause of a problem cannot be determined. To unpack and prepare the V4C-O2E Oxygen Mixer: Open the carton to remove the V4C-O2E Oxygen Mixer, the oxygen hose, and accessories from the inner cardboard box. -
Page 71: Table 11-1. Parts And Accessories Provided With The V4C-O2E Oxygen Mixer
Unpacking and Accessories Table 11-1. Parts and accessories provided with the V4C-O2E Oxygen Mixer Item Description Catalogue Number 1 x V4C-O2E Oxygen Mixer Enhances FiO range of compatible V4C-O2E ventilators. 2 x Side arms Used to secure the ventilator to the Oxygen Mixer. -
Page 72: Electromagnetic Emissions And Immunity
12 Electromagnetic Emissions and Immunity Table 12-1. Electromagnetic emissions The ventilator and Oxygen Mixer are intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the system should ensure that it is used in such an environment. Phenomenon and standard Compliance Electromagnetic Environment -... -
Page 73: Table 12-3. Electromagnetic Immunity - Conducted And Radiated Rf
Electromagnetic Emissions and Immunity Table 12-3. Electromagnetic immunity — conducted and radiated RF Phenomenon Basic EMC Standard / Immunity Test Levels for Home Healthcare Environment Test Method Radiated Field Immunity 10 V/m (80% AM at 1KHz sine) 80 MHz – 2.7 GHz IEC 60601-1-2 / IEC 61000-4-3 Proximity Fields from RF Wireless Com- Proximity Fields provided in Table 9 of... -
Page 74: Glossary
13 Glossary Battery Level Display of the remaining battery capacity; located adjacent to the battery symbol. An abbreviation for "breaths per minute," which is the unit of measure for breath rate (see below). Breath Rate The total number of breaths, both machine and spontaneous, delivered by a ventilator in one minute. - Page 75 Glossary I Time (Inspiratory Time) Inspiratory time measure. Liters per minute (a unit of volume flow rate). Max Rtot (Total Breath Rate) The maximum alarm setting to prevent hyperventilation or ventilator autotriggering. The High Rate alarm will be triggered if the total breath rate exceeds the maximum limit set. mbar An abbreviation for "millibar", which is a unit of measure for pressure.
- Page 77 © 2019 Covidien. All rights reserved. Changes © 2020-2022 Baylis Medical Technologies Inc. All rights reserved. The Baylis MedTech logo, Baylis Medical V4C-560, Baylis Medical, V4C-560, and V4C-O2E are trademarks or registered trademarks of Baylis Medical Technologies Inc in Canada and/ or other countries. All other brands are trademarks of their respective owners.
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