Baylis V4C-O2E User manual

User Manual
DMR V4C 3.3 (User Manual) V-4 06-May-2022
Baylis Medical
V4C-O2E™ Oxygen Mixer

© 2019 Covidien. All rights reserved. Changes © 2020-2022 Baylis Medical Technologies Inc. All rights reserved. The
Baylis Medical 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.
The information contained in this manual is the property of Baylis Medical Technologies Inc. ("Baylis," "Baylis Medical," or
"Baylis Medical Technologies") and may not be duplicated without permission. This manual may be revised or replaced by
Baylis at any time and without notice. You should ensure that you have the most current applicable version of this
manual; if in doubt, contact Baylis' Customer Service department or visit the Product manuals web page at:
www.baylismedtech.com/resources. While the information set forth herein is believed to be accurate, it is not a substitute
for the exercise of professional judgment. The Oxygen Mixer should be operated and serviced only by trained professionals.
Baylis' sole responsibility with respect to the Oxygen Mixer, and its use, is as stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Baylis' right to revise or otherwise change or modify the
Equipment described herein, without notice. In the absence of an express, written agreement to the contrary, Baylis
Medical Technologies has no obligation to furnish any such revisions, changes, or modifications to the owner or user of
the Equipment (including its software) described herein. To obtain information about a warranty, if any, contact Baylis'
Customer Service at [phone] or your local representative. Purchase of this Product confers no express or implied
license under any Baylis patent to use the Product with any ventilator that is not manufactured or licensed by Baylis. This
Oxygen Mixer was created for use in response to the COVID- 19 pandemic. This Oxygen Mixer uses materials, including
this manual, provided under a permissive license from Medtronic. LIMITED WARRANTY - V4C-O2E Oxygen Mixer
("Product", "Unit", Equipment or ventilator) Baylis Medical Technologies Inc. warrants the V4C-560 Oxygen Mixer against
defects in materials and workmanship to the registered owner at the time of purchase. All components of the V4C-O2E
Oxygen Mixer are covered by the warranty as described below. Under this Limited Warranty, if any covered Product is
proved to be defective in materials or workmanship, Baylis Medical will replace or repair, in its absolute and sole
discretion, any such Product, less any charges to Baylis Medical for transportation and labor costs incidental to inspection,
removal or restocking of the Product. This Limited Warranty applies only to new, original factory delivered Products that
have been used for their normal and intended uses. Baylis Medical's limited warranty shall not apply to Baylis Medical
Products which have been resterilized, repaired, altered, or modified in any way and shall not apply to Baylis Medical
Products which have been improperly stored or improperly installed, operated or maintained contrary to Baylis Medical's
instructions. This warranty does not apply to any Unit which has been subject to misuse, neglect, improper installation or
that which has been altered, adjusted or tampered with by any person other than Baylis Medical authorized personnel.
This warranty does not apply to any Product that is used in conjunction or with any unauthorized Products, Equipment,
parts, etc. If upon examination by authorized service personnel, it is determined that the malfunction is due to misuse,
abuse, or any of the violations mentioned above; warranty provisions will not apply. An estimate of the cost of repair work
will be given to the customer prior to servicing and repairing the Unit. The customer is responsible for returning the
defective Equipment to Baylis Medical at 2645 Matheson Blvd E, Mississauga, Ontario, L4W 5S4 or to a specified address if
different at his or her own expense. 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. If, upon examination, it is determined that the fault had been caused by
misuse or abnormal conditions of operation, the repairs will be billed to the customer as out-of-warranty repairs. Products
repaired under Baylis Medical standard repair program will be issued a thirty-day warranty against defects in both
materials and workmanship, provided the original warranty period has passed. Instruments submitted due to defects in
materials and workmanship during the thirty-day warranty period will be repaired at no charge to the customer.
DISCLAIMER AND LIMITATION OF LIABILITY THE LIMITED WARRANTY SET FORTH HEREIN IS EXCLUSIVE AND IN LIEU OF ALL
OTHER WARRANTIES, REMEDIES, OBLIGATIONS AND LIABILITIES OF BAYLIS MEDICAL, EXPRESSED OR IMPLIED, INCLUDING
THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE OR PURPOSE. ANY WARRANTY
OTHER THAN SET FORTH HEREIN IS EXPRESSLY DISLCAIMED. THE REMEDY SET FORTH HEREIN SHALL BE THE EXCLUSIVE
REMEDY FOR ANY WARRANTY CLAIM, AND ADDITIONAL DAMAGES, INCLUDING CONSE-QUENTIAL DAMAGES OR
DAMAGES FOR BUSINESS INTERRUPTION OR LOSS OF PROFIT, REVENUE, MATERIALS, ANTICIPAT-ED SAVINGS, DATA,
CONTRACT, GOODWILL OR THE LIKE (WHETHER DIRECT OR INDIRECT IN NATURE) OR FOR ANY OTHER FORM OF
INCIDENTAL, OR INDIRECT DAMAGES OF ANY KIND, SHALL NOT BE AVAILABLE. THESE PRODUCTS ARE BEING SOLD ONLY
FOR THE PURPOSE DESCRIBED HEREIN, AND SUCH WARRANTY ONLY RUNS TO THE PURCHASER. IN NO EVENT SHALL
BAYLIS MEDICAL BE LIABLE FOR ANY BREACH OF WARRANTY IN ANY AMOUNT EXCEEDING THE PURCHASE PRICE OF THE
PRODUCT. BAYLIS MEDICAL'S MAXIMUM CUMULATIVE LIABILITY RELATIVE TO ALL OTHER CLAIMS AND LIABILITIES,
INCLUDING OBLIGATIONS UNDER ANY INDEMNITY, WHETHER OR NOT INSURED, WILL NOT EXCEED THE COST OF THE
PRODUCT(S) GIVING RISE TO THE CLAIM OR LIABILITY. BAYLIS MEDICAL DISCLAIMS ALL LIABILITY RELATIVE TO GRATUITOUS
INFORMATION OR ASSISTANCE PROVIDED BY, BUT NOT REQUIRED OF BAYLIS MEDICAL HEREUNDER. ANY ACTION
AGAINST BAYLIS MEDICAL MUST BE BROUGHT WITHIN EIGHTEEN (18) MONTHS AFTER THE CAUSE OF ACTION ACCRUES.
THESE DISCLAIMERS AND LIMITATIONS OF LIABILITY WILL APPLY REGARDLESS OF ANY OTHER CONTRARY PROVISION
DMR V4C 3.3 (User Manual) V-4 06-May-2022

User Manual 1-iii
DMR V4C 3.3 (User Manual) V-4 06-May-2022
HEREOF AND REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND
STRICT LIABILITY) OR OTHERWISE, AND FURTHER WILL EXTEND TO THE BENEFIT OF BAYLIS MEDICAL'S VENDORS,
APPOINTED DISTRIBUTORS AND OTHER AUTHORIZED RESELLERS AS THIRD-PARTY BENEFICIARIES. EACH PROVISION
HEREOF WHICH PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTY OR CONDITION OR EXCLU-
SION OF DAMAGES IS SEVERABLE AND INDEPENDENT OF ANY OTHER PROVISION AND IS TO BE ENFORCED AS SUCH.
IN ANY CLAIM OR LAWSUIT FOR DAMAGES ARISING FROM ALLEGED BREACH OF WARRANTY, BREACH OF CONTRACT,
NEGLIGENCE, PRODUCT LIABILITY OR ANY OTHER LEGAL OR EQUITABLE THEORY, THE BUYER SPECIFICALLY AGREES
THAT Baylis Medical SHALL NOT BE LIABLE FOR DAMAGES OR FOR LOSS OF PROFITS, WHETHER FROM BUYER OR
BUYER'S CUSTOMERS. Baylis Medical'S LIABILITY SHALL BE LIMITED TO THE PURCHASE COST TO BUYER OF THE SPEC-
IFIED GOODS SOLD BY Baylis Medical TO BUYER WHICH GIVE RISE TO THE CLAIM FOR LIABILITY. No agent, employee
or representative of Baylis Medical has the authority to bind it to any other warranty, affirmation or representation
concerning the Product. This warranty is valid only to the original purchaser of Baylis Medical Products directly from
a Baylis Medical authorized agent. The original purchaser cannot transfer the warranty. The warranty period for the
V4C-O2E Oxygen Mixer is one(1) year from the shipment date. Purchaser covenants not to use the Equipment with
any unauthorized products, items, consumables, disposables, equipment and parts. 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.

User Manual iii
Table of Contents
DMR V4C 3.3 (User Manual) V-4 06-May-2022
Preface
Purpose of This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -ix
Qualification of Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -ix
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -ix
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -x
1 Safety Information
1.1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2.1 General Warnings Regarding Use of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2.2 Warnings Regarding Installation and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.2.3 FiO2 Readings and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.2.4 Warnings Regarding Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.2.5 Warnings Regarding Oxygen Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.2.6 Warnings Regarding Alarms and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.2.7 Warnings on Storage and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
1.2.8 Warnings Regarding Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
1.3 Symbols and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
2 Overview
2.1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.1 Target Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.2 Target Environments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.3 Target Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.3 Operational Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.4 Compatible Ventilators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5 Operating Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6 Device Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.7 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.8 Environmental and Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.9 Battery Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.10 If Failure Occurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
3 Alarms and Troubleshooting
3.1 Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
4 Installation and Assembly
4.1 Installation and Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2 Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

iv User Manual
Table of Contents
DMR V4C 3.3 (User Manual) V-4 06-May-2022
5 Operating Procedures
5.1 FiO 2 Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.1.1 Calibrating the V4C-560 FiO 2 Kit for Use with the V4C-O2E Oxygen Mixer . . . . . . . . . . . . . . 5-5
5.2 Changing FiO
2 During Ventilation Using a Compatible Ventilator . . . . . . . . . . . . . 5-7
5.3 Stopping Ventilation While Using the V4C-O2E Oxygen Mixer . . . . . . . . . . . . . . . . . 5-8
5.4 Using the Compatible Ventilator Without the V4C-O2E Oxygen Mixer . . . . . . . . . 5-8
6 Cleaning
7 Routine Maintenance
8 Theory of Operation
9 Operational Verification Checklist and Functional Testing
9.1 Operations Verification Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.2.1 Test 1 — Compatible Ventilator Alarms Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.2.2 Test 2 — High FiO2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.2.3 Test 3 — Low FiO2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.2.4 Test 4 — FiO2 Alarms Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
10 Part Numbers
11 Unpacking and Accessories
12 Electromagnetic Emissions and Immunity
13 Glossary

User Manual v
List of Figures
1DMR V4C 3.3 (User Manual) V-4 06-May-2022
Figure1-1. Location of labels — rear view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Figure1-2. Location of labels — bottom view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Figure1-3. Location of labels — side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Figure2-1. O2E port on the V4C-560 Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Figure2-2. V4C-O2E Oxygen Mixer features on the front and back panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Figure4-1. Attaching the first side arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Figure4-2. Attaching the second side arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Figure4-3. Compatible ventilator feet location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Figure4-4. Location of V4C-O2E Oxygen Mixer recesses (1) and posts (2).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Figure4-5. Lowering the compatible ventilator onto the V4C-O2E Oxygen Mixer . . . . . . . . . . . . . . . . . . . . . .4-6
Figure4-6. Installing the handle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Figure4-7. Gas connection tube adapter installed on the gas connection tube . . . . . . . . . . . . . . . . . . . . . . . .4-7
Figure4-8. Installing V4C-O2E Oxygen Mixer connections and air intake filter. . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Figure4-9. Gas connection tube and adapter connected to the ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Figure4-10. Confirming no filter is installed on the back of the V4C-560 Ventilator . . . . . . . . . . . . . . . . . . . . . .4-9
Figure4-11. Red markings on the electrical cable and O2E port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Figure7-1. V4C-O2E air intake filter location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
Figure8-1. V4C-O2E Oxygen Mixer theory of operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Figure8-2. Internal function of the mixing valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Figure8-3. The FiO2% output as a function of the knob’s position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

User Manual vii
List of Tables
DMR V4C 3.3 (User Manual) V-4 06-May-2022
Table1-1. V4C-O2E Oxygen Mixer symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Table1-2. V4C-O2E Oxygen Mixer labels and markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Table2-1. FiO2 specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Table2-2. Figure 2-2 legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Table2-3. V4C-O2E Oxygen Mixer specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Table2-4. Environmental conditions for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Table2-5. Environmental conditions for storage and shipping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Table2-6. Internal battery reserve capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Table3-1. V4C-O2E Oxygen Mixer troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Table4-1. Figure 4-8 legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Table6-1. Approved cleaning solutions for exterior Oxygen Mixer surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Table9-1. Operational verification checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Table9-2. Ventilator settings for high FiO2 test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
Table10-1. Part numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Table11-1. Parts and accessories provided with the V4C-O2E Oxygen Mixer . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Table12-1. Electromagnetic emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Table12-2. Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Table12-3. Electromagnetic immunity — conducted and radiated RF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2

ix
DMR V4C 3.3 (User Manual) V-4 06-May-2022
Preface
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.
Purpose of This Manual
This manual contains important information regarding the safe operation of your V4C-O2E™ Oxygen
Mixer. Your Oxygen Mixer is an electrical device that can provide years of useful service with the
proper care, as described in 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.
It is essential to read, understand and follow the instructions of the compatible ventilator before
using the V4C-O2E Oxygen Mixer.
Qualification of Personnel
Maintenance of the device must be made by authorized and trained personnel. In particular, training
for the handling of products sensitive to electrostatic discharges must include the use of electrostatic
discharge (ESD) protection devices and knowledge of the meaning of the symbol at left, as well as
using original spare parts and respecting quality assurance and traceability rules approved by
Baylis Medical Technologies.
Warranty
Information regarding your Product warranty is available from your sales representative or Baylis
Medical Technologies.

Preface
x User Manual
DMR V4C 3.3 (User Manual) V-4 06-May-2022
Manufacturer
Baylis Medical Technologies
2645 Matheson Blvd. East
Mississauga, Ontario
Canada
L4W 5S4
[T] [phone]

1-1
DMR V4C 3.3 (User Manual) V-4 06-May-2022
1 Safety Information
1.1 Definitions
This manual uses three indicators to highlight critical information: warning, caution, and note.
They are defined as follows:
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
throughout this manual.
1.2 Warnings
1.2.1 General Warnings Regarding Use of Equipment
WARNING:
Read and take account of the intended use of the V4C-O2E Oxygen Mixer before use.
WARNING:
Always read and follow all instructions and labelling of the compatible ventilator when using the
V4C-O2E Oxygen Mixer. Ensure all warnings included in the manual of the compatible ventilator
are read and understood prior to use with the V4C-O2E Oxygen Mixer.
WARNING
Indicates a condition that can endanger the patient or the ventilator operator.
Caution
Indicates a condition that can damage the Equipment.
Note
Indicates points of particular emphasis, that make operation of the ventilator more efficient or convenient.

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WARNING:
While the ventilator is in use, an alternative means of ventilation should always be available in the
event of a ventilator problem. This is particularly true for ventilator-dependent patients.
Supplementary observation, appropriate for the patient's condition, is also recommended.
WARNING:
Never obstruct the air intake port or vents for any reason.
WARNING:
Only use the V4C-O2E Oxygen Mixer with compatible ventilators listed in Section 2.4, Compatible
Ventilators and marked with an O2E port. Do not attempt to use the Oxygen Mixer with other
ventilators.
WARNING:
This V4C-O2E Oxygen Mixer must be used only under the responsibility and on the prescription of
a doctor.
WARNING:
Ventilator-dependent patients should always be monitored by trained and competent medical
personnel. Patients should be regularly checked to ensure that the oxygen concentration settings
match with the patient condition.
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.
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.
WARNING:
If at any time it is observed that excessive and consistent gas is exiting through the vents at the
back of the 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.

Warnings
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
WARNING:
Oxygen therapy for patients with respiratory failure is a common and effective medical
prescription; however, be aware that inappropriate oxygen use may potentially lead to serious
complications, including, but not limited to, patient injury.
WARNING:
When a ventilator alarm condition is triggered, or there is evidence of a patient-ventilator fault or
problem, examine the patient first before examining the ventilator.
WARNING:
Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because
a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient.
In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and
serious injury or death.
WARNING:
Using the ventilator in battery mode while the V4C-O2E Oxygen Mixer is electrically connected,
but not connected to an oxygen source can decrease the battery level of the ventilator. If the
ventilator-V4C-O2E Oxygen Mixer system is being used without additional oxygen, follow
instructions in Section 5.4, Using the Compatible Ventilator Without the V4C-O2E Oxygen 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, Battery Capacity to understand battery life when using V4C-O2E Oxygen
Mixer with a compatible ventilator.
WARNING:
The inspiration trigger threshold should be carefully modified in order to avoid the risk of false
triggering or "autotriggering" of the ventilator. The least sensitive setting may result in
autotriggering. In these scenarios, auto-triggering may be reduced by decreasing the FiO2 level or
using an inspiratory bacterial filter with a higher flow resistance. Always set an appropriate "Max
Rtot" alarm limit when using inspiration triggering with the V4C-O2E Oxygen Mixer.
WARNING:
The delivered FiO2 may be affected by a change in breath settings. When settings are adjusted or
changed due to patient status, check the FiO2 being delivered and adjust the oxygen knob as
needed. See Section 5.2, Changing FiO2 During Ventilation Using a Compatible Ventilator for
instructions on how to adjust the FiO2.
WARNING:
The V4C-O2E Oxygen Mixer must not be used with flammable anesthetic substances.

Safety Information
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
WARNING:
To reduce the risk of infection, wash your hands thoroughly before and after handling the Oxygen
Mixer or its accessories.
WARNING:
While the V4C-O2E Oxygen Mixer-Ventilator system is in use, an alternative means of ventilation
should always be available in the event of a problem with the Oxygen Mixer. This is particularly
true for ventilator-dependent patients. Supplementary observation, appropriate for the patient's
condition, is also recommended.
1.2.2 Warnings Regarding Installation and Accessories
WARNING:
Always perform recommended tests of the compatible ventilator per its manual and the
recommended V4C-O2E Oxygen Mixer tests in Section 9.2, Functional Tests prior to connecting a
patient.
WARNING:
Never perform tests that could disrupt ventilation while the patient is being ventilated. Always
provide an alternate means of ventilation where applicable.
WARNING:
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 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. Similarly, do not use
V4C-O2E Oxygen Mixer if its rubber feet are missing.
WARNING:
Do not place anything in the space between the bottom of the ventilator and the top of the V4C-
O2E Oxygen Mixer. Cooling vents located in this space may become compromised.

Warnings
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
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.
WARNING:
Ensure that the patient is not positioned in a way that could lead to accidental disconnection.
WARNING:
Check that the tube connection between the V4C-O2E Oxygen Mixer and ventilator is well
connected and not pinched before beginning ventilation. Take care when connecting the gas
connection tubing, not to pinch or compromise its patency.
WARNING:
If any of the assembly steps in Section 4.1, Installation and Assembly cannot be completed do not
use the V4C-O2E Oxygen Mixer. Contact your customer service representative.
WARNING:
Never use the V4C-O2E Oxygen Mixer or components that appear to be damaged or faulty.
Contact Baylis Medical Technologies if the cause of a problem cannot be determined.
WARNING:
Verify the functionality of the alarms on the compatible ventilator before connecting the patient
to the ventilator. See the manual of the compatible ventilator and the instructions in Section 9.2,
Functional Tests.
WARNING:
Before starting ventilation, ensure that the V4C-O2E Oxygen Mixer and compatible ventilator are
properly assembled and that the system's air intake filter and cooling vents are not obstructed.
Refer to Section 2.6, Device Features for the locations of these features. Also ensure that the
patient circuit is of the proper configuration (double or single limb), properly connected to the
ventilator, and that the circuit hoses are neither damaged nor compressed and contain no
obstructions or foreign bodies.
WARNING:
When disconnecting the oxygen supply hose, or at any other time, do not disconnect the oxygen
mixer's Oxygen Inlet Module (See Section 2.7, Specifications) or the fittings that accompany it.
These are critical components which assure the safe use of the oxygen mixer and must remain on
the device at all times, including storage. For safe disassembly see instructions in Section 4.2,
Disassembly.

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1.2.3 FiO2 Readings and Calibration
WARNING:
Always measure the delivered oxygen with a calibrated oxygen analyzer (FiO2 kit) that features a
minimum and maximum concentration alarm in order to ensure that the prescribed oxygen
concentration is delivered to the patient.
WARNING:
If using the V4C-560 FiO2 kit, changes in the ventilator’s settings or mode may affect the
calibration of the sensor. For the most accurate FiO2 readings, recalibrate the sensor after any
significant changes to the ventilator settings. If recalibrating follow the directions in Section 5.1,
FiO2 Sensor Calibration.
WARNING:
If using the V4C-560 FiO2 kit, the FiO2 sensor may drift out of calibration as the ventilator initially
warms; therefore, a two-step calibration is recommended whereby the sensor is first calibrated
cold and then re-calibrated once it has warmed. See Sections 5.1, FiO2 Sensor Calibration and 5.2,
Changing FiO2 During Ventilation Using a Compatible Ventilator for further instructions.
WARNING:
When setting FIO2 do not overturn the oxygen knob. Stop once resistance is felt. See Figure 2-1 for
location of knob.
1.2.4 Warnings Regarding Environmental Conditions
WARNING:
Read and take account of the environmental condition ranges for proper operation before using
the V4C-O2E Oxygen Mixer.
WARNING:
Do not use the V4C-O2E Oxygen Mixer at an atmospheric pressure or temperature outside of the
range stated in Section 2.7, Specifications. Using the Oxygen Mixer outside of the specified
temperature or atmospheric pressure range can affect the Oxygen Mixer performance and can
result in patient injury or death.
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.

Warnings
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
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.
WARNING:
Wait for the device temperature to stabilize before using it after a transport or storage period.
1.2.5 Warnings Regarding Oxygen Supply
WARNING:
The hose connecting the V4C-O2E Oxygen Mixer to the oxygen source is designed exclusively for
use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by
the user. In addition, the hose must be installed without the use of lubricants.
WARNING:
Ensure that the gas connection is medical-grade oxygen. Never use a gas other than oxygen with
the V4C-O2E Oxygen Mixer.
WARNING:
Ensure the oxygen supply delivers a pressure and flow rate within the ranges stated in Section 2.7,
Specifications. Providing oxygen outside of the specified range may affect the breath delivered to
the patient. Never exceed the maximum pressure specified.
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.
WARNING:
Ensure sufficient supply of oxygen is available for the duration of ventilation.
WARNING:
If the oxygen supplied to the V4C-O2E Oxygen Mixer is less than 100% O2 the maximum FiO2
delivery will be decreased.
WARNING:
Turn off or disconnect oxygen supply when the V4C-O2E Oxygen Mixer is not in use.

Safety Information
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
WARNING:
Turn off oxygen supply if abnormal behavior of the device is observed and provide the patient
with an alternative means of ventilation.
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. Safety valves on the V4C-O2E Oxygen Mixer ensure that room air is always available
to the ventilator in all fault conditions, including in an oxygen loss scenario.
WARNING:
Never use the V4C-O2E Oxygen Mixer and the low pressure oxygen port of the compatible
ventilator simultaneously. Only one source of oxygen can be delivered to the ventilator during
use.
WARNING:
Do not connect high pressure oxygen directly to the ventilator. Always follow the instructions on
the compatible ventilator when using its low flow oxygen port to deliver oxygen.
WARNING:
In the event of an oxygen leak, shut down the supply of oxygen at its source. In addition, remove
and/or keep any incandescent source away from the device, which may be enriched with oxygen.
Circulate fresh air into the room to bring the oxygen level down to normal.
WARNING:
The electrical connecting cable between the V4C-O2E Oxygen Mixer and the compatible ventilator
delivers power to the Oxygen Mixer. It will automatically begin oxygen delivery when the
ventilator enters an active ventilation state. Disconnecting this cable will cease power and oxygen
delivery to the V4C-O2E Oxygen Mixer.
1.2.6 Warnings Regarding Alarms and Troubleshooting
WARNING:
Never use the V4C-O2E Oxygen Mixer without an appropriate FiO2 monitor. Always ensure that
the sensor has been properly calibrated before use. See Section 5.1, FiO2 Sensor Calibration for
calibration instructions.

Warnings
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
WARNING:
Never use the V4C-O2E Oxygen Mixer without appropriately setting both high and low FiO2 alarms
on the compatible ventilator or FiO2 monitor.
WARNING:
Never use the V4C-O2E Oxygen Mixer without appropriately setting both high and low pressure/
volume alarms on the compatible ventilator.
WARNING:
Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not
to activate during ventilation, which reduces its ability for monitoring the patient and alerting the
clinician to situations that may require intervention.
WARNING:
Do not attempt to open, repair or otherwise service the V4C-O2E Oxygen Mixer yourself. Doing so
might endanger the patient, damage the ventilator, and/or void your warranty. Only personnel
authorized and qualified by Baylis Medical Technologies should repair, open or service the V4C-
O2E Oxygen Mixer.
1.2.7 Warnings on Storage and Maintenance
WARNING:
It is recommended to store the V4C-O2E Oxygen Mixer attached to the compatible ventilator and
with the air connection tubing attached (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.
WARNING:
To ensure proper performance of the Oxygen Mixer, the preventative maintenance schedule
should be followed, per Section 7, Routine Maintenance. For further information contact Baylis
Medical Technologies. Failure to do so can result in malfunctioning or the device, which may
result in patient injury.
WARNING:
Never use cleaners inside of the gas pathways. Always follow cleaning instructions indicated in
Section 6, Cleaning.
WARNING:
A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or
contaminated equipment is a potential source of infection. Clean the V4C-O2E Oxygen Mixer and
its accessories regularly and systematically before and after each use and following any

Safety Information
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DMR V4C 3.3 (User Manual) V-4 06-May-2022
maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the
ventilator's outlet is required when using the Oxygen Mixer. To reduce the risk of infection, wash
your hands thoroughly before and after handling the Oxygen Mixer.
WARNING:
Use all cleaning solutions and products with caution. Read and follow the instructions associated
with the cleaning solutions you use to clean your Oxygen Mixer. Use only those solutions listed in
Table 6-1.
WARNING:
The Oxygen Mixer should never be immersed in any liquid, and any liquid on the surface of the
device should be wiped away immediately. To avoid damage to the Oxygen Mixer, in particular the
electrical components, fluids must not be allowed to enter the device, particularly through the
Oxygen Mixer's air intake filter or the cooling/venting apertures located on the rear and bottom
panels of the Oxygen Mixer.
1.2.8 Warnings Regarding Filters
WARNING:
Do not use the V4C-O2E Oxygen Mixer without an inspiratory bacterial filter between the
ventilator's outlet and the patient. Doing so can cause cross-contamination of the V4C-O2E
Oxygen Mixer or delivery of contaminants to the patient.
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.
WARNING:
If the Oxygen Mixer's air intake filter appears visibly soiled, replace it even if the recommended
maintenance period has not yet elapsed.
WARNING:
Never use the device without an air intake filter installed. Always use the approved filters. Use of
an incorrect filter may impact breath delivery. See Section 2.7, Specifications for filter
specifications and Section 4.1, Installation and Assembly for installation instructions.
WARNING:
Do not use the V4C-O2E Oxygen Mixer with filters whose flow resistance is greater than allowable.
Doing so may increase circuit resistance and compromise spontaneous breathing. For information
on allowable filter resistances see Section 2.7, Specifications.

Symbols and Labels
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WARNING:
Always ensure that any filters are removed from the back of the ventilator before connecting the
gas connection tube of the Oxygen Mixer. Using the V4C-O2E Oxygen Mixer with the ventilator's
air intake filter in place at the back of the ventilator could impact flow resistance of the system.
1.3 Symbols and Labels
Various labels or specific markings are affixed to the V4C-O2E Oxygen Mixer that describe precau-
tions to be taken for the correct use and to contribute to the traceability of the Product. See
Table 1-1 for illustrations of these labels and markings and Table 1-2 for their locations on the V4C-
O2E Oxygen Mixer. Use the item numbers in Table 1-2 to locate the labels in Figure 1-1, Figure 1-
2, and Figure 1-3.
Table1-1.V4C-O2E Oxygen Mixer symbols
Symbol Description
Air intake; do not obstruct.
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.
It is mandatory to read, understand, and follow these instructions before using the V4C-O2E Oxygen Mixer.
This symbol appears on the Oxygen Mixer's back panel.
Manufacturer.
Date of manufacture.
Serial number.