V60 Anesthetic Vaporizer Operators Manual Rev 3.0 Nov 2015

© 2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. Operator's Manual issue date November, 2015.

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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. , and China and other countries.

are the trademarks, registered or otherwise, of Mindray in

All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

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Manufacturer's Responsibility Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: „ all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; „ the electrical installation of the relevant room complies with the applicable national and local requirements;and „ the product is used in accordance with the instructions for use.

WARNING z z

This anesthetic vaporizer must be operated by skilled/trained clinical professionals. It is important for the hospital or organization that uses this equipment to perform a reasonable service/maintenance plan. Neglecting this may result in machine breakdown or personal injury.

Warranty Mindray DS USA, Inc. warrants that components within its products will be free from defects in workmanship and materials for the number of years shown on the invoice. Under this extended warranty, Mindray DS USA, Inc. will repair or replace any defective component at no charge for labor and/or materials. Recommended preventative maintenance, as prescribed in the Maintenance section of this manual, is the responsibility of the user, and is not covered by this warranty. Except as otherwise provided herein, the terms, conditions, and limitations of Mindray DS USA, Inc.ÿ s standard warranty will remain in effect. Mindray DS USA, Inc. warrants that its products will be free from defects in workmanship and materials for a period of one (1) year from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner. Mindray DS USA, Inc. will not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products, liability under this warranty and the buyerÿs exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA, Inc.ÿs option at the factory or at an authorized distributor, any product which shall under normal use and service appear to the Company to have been defective in material or workmanship. V60 Anesthetic Vaporizer Operator’s Manual

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No agent, employee, or representative of Mindray DS USA, Inc. has any authority to bind Mindray DS USA, Inc. to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer. This warranty is expressly in lieu of any other express or implied warranties, including any implied warranty or merchantability or fitness, and of any other obligation on the part of the seller. Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments or by any customer modification voids this warranty. Mindray DS USA, Inc. makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers. A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah, New Jersey 07430. Mindray DS USA, Inc. shall not have any responsibility in the event of loss or damage in transit.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: „ Malfunction or damage caused by improper use or man-made failure. „ Malfunction or damage caused by unstable or out-of-range power input. „ Malfunction or damage caused by major forces such as fire and earthquake. „ Malfunction or damage caused by improper operation or repair by unqualified orunauthorized service people. „ Malfunction of the instrument or part whose serial number is not legible enough. „ Others not caused by instrument or part itself.

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Service Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-8000 for assistance in determining the nearest field service location. Please include the instrument model number, the serial number, and a description of the problem with all requests for service. Any questions regarding the warranty should be directed to your local sales or service representative.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Website:

Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

Distributor:

Mindray DS USA, Inc.

Address:

800 MacArthur Blvd., Mahwah, NJ 07430

Dom. Customer Service:

1.800.288.2121

Intl. Customer Service:

+1.201.995.8000

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FOR YOUR NOTES

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Table of Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Warnings... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-3 1.2 Anesthetic Vaporizer Symbols ... 1-4 2 The Basics ... 2-1 2.1 Product Description ... 2-1 2.2 Intended Use ... 2-2 2.3 Anesthetic Vaporizer Appearance... 2-2 2.3.1 Front View ... 2-2 2.3.2 Rear View ... 2-3 2.4 Configuration Differences ... 2-4 3 Method of Operation... 3-1 3.1 Control Dial... 3-1 3.2 Connecting and Interlock System ... 3-1 3.2.1 Plug-in Adapter/Plug-in Connector ... 3-2 3.2.2 Interlock Device ... 3-3 3.3 Filling System ... 3-4 4 Filling and Draining ... 4-1 4.1 Checks before Filling ... 4-1 4.2 Filling the Vaporizer ... 4-1 4.2.1 Key Filler System... 4-2 4.2.2 Quik-Fil System ... 4-7 4.3 Draining the Vaporizer ... 4-9 4.3.1 Key Filler System... 4-9 4.3.2 Quik-Fil System ... 4-12 4.4 Blowing off the Vaporizer ... 4-14 5 Checks before Use ... 5-1 5.1 Checklist-checks before each use ... 5-1 5.2 Setting Checks... 5-2 6 Basic Operations ... 6-1 6.1 Connecting the Vaporizer ... 6-1 6.2 Adjusting the Concentration of Anesthetic Agent ... 6-4 6.3 Switching off the Vaporizer ... 6-5 6.4 Disconnecting the Vaporizer ... 6-6 6.5 Moving when Filled ... 6-6 7 Cleaning and Disinfecting... 7-1 7.1 Cleaning ... 7-1 7.2 Disinfecting ... 7-2 8 User Maintenance... 8-1 8.1 Repair Policy ... 8-1 8.2 Maintenance Schedule ... 8-1 V60 Anesthetic Vaporizer Operator’s Manual

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8.3 Checking the Concentration ... 8-2 8.4 Checking the Filling System ... 8-3 8.5 Checking the Plug-in Adapter ... 8-3 9 Troubleshooting ... 9-1 9.1 Operation Related Faults and Remedies ... 9-1 9.2 Filling and Draining Related Faults and Remedies ... 9-3 9.3 Plug-in Adapter Related Faults and Remedies ... 9-3 10 Storage and Transport ... 10-1 10.1 Storage ... 10-1 10.2 Transport ... 10-1 11 Theory of Operation ...11-1 11.1 Operating Principle ...11-1 11.2 Calibration ...11-3 11.3 Influence of Temperature ...11-3 11.4 Influence of Flow ...11-5 11.5 Influence of Gas Composition ...11-6 11.6 Influence of Atmospheric Pressure...11-7 11.7 Influence of Fluctuations in Pressure ...11-8 11.8 Influence of Running Time...11-8 11.9 Anesthetic Agent Consumption ...11-9 A Product Specifications ... A-1 A.1 Standards Compliance ... A-1 A.2 Physical Specifications ... A-1 A.3 Operating Range... A-2 A.4 Performance Specifications ... A-2 A.5 Product Configurations ... A-3 A.6 Flow Range ... A-3 B Accessories List ... B-1 C Symbols and Terminology ... C-1 C.1 Symbols ... C-1 C.2 Terminology ... C-1

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1 Safety 1.1 Safety Information WARNING z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE z

Provides application tips or other useful information to ensure that you get the most from your product.

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1.1.1 Warnings WARNING z z z z z z z z z z z z z z

z

Do not operate the anesthetic vaporizer before reading this manual. The user of the anesthetic vaporizer must fully understand and strictly follow the instructions for use. Before putting the system into operation, the user must verify that the anesthetic vaporizer is in correct working order and operating condition. Do not use the anesthetic vaporizer in the environment outside the specified temperature and pressure ranges. To avoid explosion hazard, do not use the anesthetic vaporizer in the presence of flammable anesthetic agent, vapors or liquids. Dispose of the package material, observing the applicable waste control regulations and keep them out of children’s reach. To avoid explosion hazard, use only specified non-combustible anesthetic agent in compliance with the requirement of ISO8835-4. Any unauthorized organization or untrained person must not change or disassemble the anesthetic vaporizer. This anesthetic vaporizer may not be modified without the manufacturer’s permission. The medical device must be inspected and serviced regularly by authorized service personnel. Before use, check that the shipping package is intact. The anesthetic vaporizer shall not be serviced or maintained while in use with a patient. Do not use the anesthetic vaporizer when there is an anesthetic agent leak. The vaporizer is designed for use only with the specific anesthetic agent named on the filler block (and further indicated by labels of different colors). Do not use the vaporizer if the vaporizer is filled with any agent other than the agent specified on the front label. This anesthetic vaporizer is not suitable for use in an MRI environment.

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1.1.2 Cautions CAUTION z z z z

Use only accessories specified in this manual. At the end of its service life, the anesthetic vaporizer, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. The anesthetic vaporizer may become unstable if the unit is tilted beyond 10 degrees. Always install or carry the anesthetic vaporizer properly to avoid damage caused by drop, impact, strong vibration or other mechanical force. Do not carry by the control dial or the handle for locking lever.

1.1.3 Notes NOTE z z

Keep this manual close to the anesthetic vaporizer so that it can be obtained conveniently when needed. This manual describes all features and options. Your anesthetic vaporizer may not have all of them.

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1.2 Anesthetic Vaporizer Symbols Refer to instruction manual/booklet

Gas flow direction

Adjust concentration as the arrow shows

Press and lock as the arrow shows

Caution

MR Unsafe – do not subject to magnetic resonance imaging (MRI) The device has been type tested to the regulatory requirements and bears the SGS Mark for safety. SGS is Nationally Recognized Test Laboratory (NRTL) per OSHA. Rx only

U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.

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2 The Basics 2.1 Product Description This vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system. Each vaporizer is calibrated for a specified anesthetic agent and is only suitable for that anesthetic agent. The specific agent that the vaporizer must be used with is marked in text and by specific color on the vaporizer. The vaporizer compensates for variations of temperature, pressure and flow. Therefore, under the circumstances specified in this manual, the output concentration of the vaporizer is not influenced by ambient conditions, such as temperature, gas flow and ventilation pressure. The anesthetic vaporizer is not suitable for use with an anesthetic delivery system with vaporizer placed inside the circuit system due to relatively high internal pneumatic resistance. The vaporizer delivery system is in compliance with ISO8835-4. The Key Filler system is in compliance with ISO5360. Quik-Fil system complies with the performance data of ISO5360. Mindray recommends that the output concentration is monitored through an anesthetic gas monitoring device in compliance with ISO80601-2-55 to detect any hazardous output values. Use an anesthetic gas scavenging system in compliance with ISO8835-3 to minimize atmospheric pollution in the operating room.

WARNING z

Do not use the anesthetic vaporizer in mobile vehicles, aeroplanes, helicopters and / or ships.

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2.2 Intended Use

V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system. The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.

WARNING z

z

The anesthetic vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer. This anesthetic vaporizer is not suitable for use in an MRI environment.

2.3 Anesthetic Vaporizer Appearance 2.3.1 Front View 1. 2. 3. 4. 5. 6.

“0” button Control dial Filling system Color mark for anesthetic agent Sight glass for filling level Drainage screw

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2.3.2 Rear View 1. 2. 3.

Handle for locking lever Interlock system Locking pin

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2.4 Configuration Differences Model Anesthetic agent Filling system Picture

Sevoflurane Key Filler Vaporizer Sevoflurane Key Filler system

Isoflurane Key Filler Vaporizer Isoflurane Key Filler system

Sevoflurane Quik-Fil Vaporizer Sevoflurane Quik-Fil system

Filler Accessory

Drainage Accessory

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3 Method of Operation 3.1 Control Dial The control dial is used to set the output concentration of the anesthetic agent. The control dial is marked with output concentration of the anesthetic agent from the vaporizer. The graduation to which the dial is turned indicates the output concentration. The “0” button on the vaporizer has a locking function. Press this button first before turning the control dial. control dial “0” button

If the vapor is stored in high temperature and then used, the concentration of the delivered anesthetic agent may be high. To enable pressure equalization, always turn the control dial to 1% after connecting to the anesthetic workstation, and wait for at least 15 seconds.

3.2 Connecting and Interlock System When the anesthetic delivery system is connected to multiple vaporizers, the interlock systems of the vaporizers ensure that only one vaporizer can be switched on at any one time while the others remain off and in a locked state.

Interlock device

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3.2.1 Plug-in Adapter/Plug-in Connector The vaporizer is for use with anesthetic delivery systems utilizing the Ohmeda Selectatec® compatible manifold system. The openings in the plug-in adapter on the vaporizer fit onto the pins on the plug-in connector on the anesthetic delivery system. Plug-in adapter and pin

Plug-in connector

To connect/disconnect the vaporizer, the control dial must be at the “0” setting indicating locked status.

Control dial at the “0” setting

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Press the handle for locking lever and turn the handle clockwise for 90eto lock the vaporizer and counter clockwise for 90eto release locking.

Initial position Locked position

3.2.2 Interlock Device

Ohmeda Selectatec® compatible interlock device is used. When the anesthetic delivery system is connected to multiple vaporizers, if one vaporizer is switched on, the two pins on the interlock device are pushed out, preventing other vaporizers from being switched on.

WARNING z z

Before operation, check if the interlock device is fully functional. A malfunction in the interlock system can endanger the patient by overdosing or mixing anesthetic agents.

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