Continuous-Intermittent Vacuum Regulator Operating and Maintenance Manual Rev 3 Oct 2020

Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Intermittent Vacuum Regulator Part Identification

1

Face Assembly (Continuous/Intermittent)

15

Back Plate

2

Analog Lens

16

Cover Screws (4 pcs)

17

Back Plate Screws (2 pcs)

Gauge: 0-100 mmHg Gauge (Analog or Digital) 3

0-160 mmHg Gauge (Analog or Digital) 0-300 mmHg Gauge (Analog or Digital)

2

4

Gauge O-Rings (2 pcs)

18

Bottom Plate Screw

5

Selector Screw

19

Orifice

6

Selector Face Plate (3 mode, 2 mode Intermittent)

20

Regulating Module (Standard, Pediatric & Neonatal Regulating Module)

7

Selector Switch

21

Port O-Rings (2 pcs)

8

Selector O-Ring

22

Port Plug

9

Index Ball

23

Pediatric Relief Screw (Pediatric Model Only)

10

Index Spring

24

Pediatric Relief Body (Pediatric Model Only)

11

Back Body

25

Pediatric Relief Ball (Pediatric Model Only)

12

Selector Plug

26

Pediatric Relief O-Ring (Pediatric Model Only)

13

Selector Plug O-Ring

27

Intermittent Module

14

Back Gasket

28

Chamber O-Ring

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Important: Safety Instructions This manual provides you with important information about the Vacuum Regulators and should be read carefully to ensure the safe and proper use of this product. Read and understand all the safety and operating instructions contained in this booklet. If you do not understand these instructions, or have any questions, contact your supervisor, dealer or the manufacturer before attempting to use the apparatus.

WARNING

Indicates a potentially hazardous situation, which if not avoided, could result in death or serious injury

ATTENTION Indicates a potentially hazardous situation, which if not avoided, could result in minor or moderate injury CAUTION

Indicates a potentially hazardous situation, which if not avoided, could result in damage to the device or other property Complies with the requirements of Directive 93/42/EEC Caution

Serial Number

Consult operating manual

Manufacturer

Manufacturer’s authorized representative in the European Union

Product Disposal Instructions

Caution: Federal (USA) Law restricts this device to sale by or on the order of a licensed healthcare provider. Catalog Number (Device Identifier) The stork symbol indicates low pressure vacuum gauge commonly used for pediatric and neonatal applications Analog gauges include color coding along the graduation marks as follows:

GAUGE COLORS

Analog Gauge Color

160 mmHg Gauge

300 mmHg Gauge

Green

0 – 80 mmHg Graduations

0 – 80 mmHg Graduations

Yellow

80 – 120 mmHg Graduations

80 – 120 mmHg Graduations

Orange

120 – 160 mmHg Graduations

120 – 200 mmHg Graduations

Red

N/A

200 mmHg – Full Graduations

Receiving Inspection Remove product from package and inspect for damage. If product is damaged, DO NOT USE and contact your dealer or equipment provider. ATTENTION:

It is very important to allow product to remain in original packaging for 12-24 hours to acclimate to room temperature before use.

User Responsibility WARNING: The procedures described in this service manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. Read completely through each step in every procedure before starting this procedure; any exceptions may result in a failure to properly and safely complete the attempted procedure. No repairs should ever be undertaken or attempted by anyone not having such qualifications. Genuine Amvex replacement parts must be used for all repairs. This product performs as explained in this manual as long as the assembly, use, repair and maintenance are properly followed according to our instructions. Elastomers and other components may become worn VR-I-MANUAL (Rev. 3) 10/2020

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

over period of use. Periodic examination of this device is recommended. If any damage or defects are present, the product should not be used. This includes parts that may have been altered, contaminated, worn or missing. Replacement parts are available as listed on the last page of this manual. WARNING:

Operation of this device is not to be done if flammable, anesthetics are present due to the possibility of explosion caused by static discharge.

MRI WARNING:

This product may contain magnetic, ferrous material that may affect the result of an MRI. For MR Conditional options, contact your Ohio Medical Representative at 1.866.549.6446.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING:

Use of accessories, transducers and cables could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. No cables, transducers, or accessories are required for operation.

WARNING:

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Amvex Vacuum Regulator. Otherwise,degradation of the performance of this equipment could result.

Intended Use Amvex Vacuum Regulators are intended to regulate a supplied vacuum pressure to the users desired vacuum level. A gauge shows the value of the regulated vacuum, which is adjustable via a regulating knob.

Specifications Vacuum Regulator Model

Gauge Range

Gauge Accuracy Analog

Digital

Continuous / Intermittent

0 - 300 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Pediatric Continuous / Intermittent

0 - 160 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Neonatal Continuous / Intermittent

0 - 100 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Please note: F.S. = Full Scale

Flow Rates

Standard

Pediatric

Continuous

0 – 80 L/min

0 – 40 L/min

Intermittent

0 – 8 L/min

0 – 2.5 L/min

Battery

Two 2/3 AA, 3.6V, 1.6 Ah, Lithium

Environmental Specifications Operating Temperature Range 50 to 104ºF (10 to 40ºC) Storage and Transport Temperature Range -13 to 158ºF (-25 to 70ºC) Operating Atmospheric Pressure Range 80 to 106 kPa Storage and Transport Atmospheric Pressure Range 50 to 106 kPa Operating and Storage Relative Humidity 5 to 95% RH (Non-condensing) Ingress Protection Rating IP 20

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Operating Instructions ATTENTION:

The operating and storage temperature for the regulator should reflect typical environmental conditions of a medical facility environment.

WARNING:

DO NOT change, alter or modify the intended use of the product.

NOTE:

Performance may vary in relation to the source vacuum pressure levels. The device will continue to perform as intended across a very broad range of vacuum levels, however, some characteristics particularly the intermittent timing, will vary with significant difference from 500 mmHg (66.7 kPa) used for factory setup.

Other Equipment Needed: ¼” (0.635 cm) Suction tubing, Suction filter or overflow safety trap, collection canister. Equipment Setup: Depending on the desired location of the regulator, connect the vacuum adapter directly into the wall outlet, or connect one end of an Amvex vacuum hose assembly onto the supply port of the suction regulator and the other end onto the vacuum source (i.e. wall outlet). Use ¼” suction tubing, between the patient and patient port of the collection canister, as well as between the outlet port of the Vacuum Regulator and canister. A high flow suction filter and/or an overflow safety trap between the regulator and the collection canister should be used to prevent occlusion or contamination of the regulator, wall outlet or pipeline system. Selecting the Mode: REG

Allows degree of vacuum to be adjusted by use of the regulating knob.

OFF

Vacuum is no longer on or being supplied to patient.

INT

Vacuum in intermittent (cycling between “ON” and “OFF”). Degree of vacuum can be adjusted with the regulating knob.

Please note: REG mode is only available on the 3 mode models

Battery Low Indicator (Digital Models Only): NOTE: When a battery icon appears on the gauge it indicates that the battery is low. Please take the unit out of service immediately and contact an Ohio Medical Customer Service Representative for battery replacement. If the low battery condition is not addressed and the battery becomes fully depleted, the gauge will not show any readout including the low battery icon or gauge pressure. If the gauge were to go blank during suctioning, the unit will continue to suction and the intermittent feature will continue to operate. Once completing that procedure, It is important to immediately take the unit out of service and contact an Ohio Medical Customer Service Representative for battery replacement. VR-I-MANUAL (Rev. 3) 10/2020

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Procedures Prior to Use: WARNING: The following tests are recommended prior to use on each patient. If the Vacuum Regulator does not pass one or more of the following tests, it should be evaluated, repaired and/or replaced by a qualified individual. The following tests must be done with a minimum supply vacuum of -53 kPa (-400 mmHg): 1. Move the selector switch to the “OFF” position. Turn the regulator knob one complete turn in the clockwise direction. Kink the vacuum tubing to block the outlet. There should be no movement of the gauge needle (or in case of a digital gauge, no change in display). 2. Move the selector switch to the “REG” position. Turn the regulator knob fully in the counter-clockwise direction. Kink the vacuum tubing; again, there should be no movement of the gauge needle (or in case of a digital gauge, no change in display). 3. Kink vacuum tubing. Regulator Setting: Standard: Pediatric & Neonatal:

Increase the vacuum to -12 kPa (-90 mmHg) Increase the vacuum to -5 kPa (-40 mmHg)

4. Open and close the kinked vacuum tubing slowly to reach various vacuum rates. Ensure that the level of vacuum maintains consistently when the vacuum tubing is kinked. 5. Move the selector switch to “INT”. 6. Kink vacuum tubing. 7. Timing cycles are approximately 16 seconds on and 8 seconds off. NOTE:

The intermittent unit starts in the off cycle.

NOTE:

Timing is preset at factory using a source vacuum level of 500 mmHg (66.7 kPa). Timing may vary in relation to the source vacuum pressure.

8. Decrease the vacuum level to zero and move the selector switch to the “OFF” position. Pediatric & Neonatal: 9. In the “REG” position, kink the vacuum tubing and turn the regulator control knob fully in the clockwise direction to ensure that the vacuum level does not go over -21 kPa (-160 mmHg) for Pediatric and -13 kPa (-100 mmHg) for Neonatal. NOTE:

This feature is only present in the Pediatric and Neonatal models.

10. Decrease the vacuum level to zero and move the selector switch to the “OFF” position. WARNING: Always verify vacuum setting prior to performing any procedure. Vacuum levels set in the “REG” mode will remain the same when switched to the “INT” mode; and vacuum levels set in the “INT” mode will remain the same when switched to the “REG” mode. CAUTION: When the collection canister is full DO NOT operate the Vacuum Regulator. The WARRANTY WILL BE VOIDED if the canister overflows and contaminates the Vacuum Regulator.

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Setting the Level of Vacuum for Patient use: 1. Complete Procedures Prior to Use. 2. Move the selector switch to the “REG” position. 3. Kink the vacuum tubing. 4. Set the required vacuum level. WARNING:

The vacuum tubing must be kinked to ensure that the patient is not exposed to a higher level of vacuum than what is required.

5. Move the selector switch to the “OFF” position. 6. Attach the vacuum tubing to the vacuum canister.

Vacuum Regulator

Suction Filter

Vacuum Tubing

Collection Canister

Overflow Vacuum Trap

Instructions for Setting the Intermittent Timing: 1. Remove the four cover screws [16] located at the back of the Vacuum Regulator and pull the Face Assembly [1] from the Back Body [11]. 2. Connect the Supply Port of the Vacuum Regulator to a vacuum source. 3. Occlude the Patient Port. 4. Switch the Vacuum Regulator to “INT” mode. 5. The Intermittent Module [27] must be held firmly against the Vacuum Regulator body during timing.

6.

7. 8. 9.

Intermittent Module OFF Needle Valve ON Needle Valve

NOTE: T  he off time must be adjusted prior to the on time. The unit will begin in the off mode of the intermittent cycle. To increase the off time, turn the “OFF” Needle Valve clockwise. To decrease the off time, turn the “OFF” Needle valve counterclockwise. After the off time has been adjusted to the desired timing the on time may be adjusted. To increase the on time, turn the “ON” Needle Valve clockwise. To decrease the “ON” time, turn the “ON” Needle Valve counterclockwise. Once the desired cycle time has been reached, slide the Face Assembly [1] back on the Back Body [11] and re-insert the four Cover Screws [16]. Amvex recommends that the user complete the Procedures Prior to Use List to assure Vacuum Regulator is operating correctly.

CAUTION: The Intermittent Module should never be disassembled. If damaged, please contact Ohio Medical for replacement.

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Cleaning Instructions The following internal cleaning procedure may be followed if your unit becomes contaminated. 1. Connect the supply port of the Vacuum Regulator to the patient port of a collection canister. Mode Selector Switch 2. Attach the vacuum port of the collection canister to a vacuum source. Supply Port 3. Connect a hose from the patient port of the Regulator to be cleaned and place the other end into a container Regulating Knob To Vacuum Source Patient Port containing 100cc of a cold sterilant. 4. Fully increase the regulating knob of the vacuum regulator (clockwise). 5. Turn on the Vacuum Regulator to the “REG” mode. Wait until all of the cold sterilant is passed through the regulator. 6. Repeat steps 3,4 & 5 for all modes of the Vacuum Container with cold sterilizer/alcohol Regulator. 7. Repeat steps 3, 4 & 5 using 100cc of isopropyl alcohol to purge the Vacuum Regulator of the sterilant. 8. The Regulator should run for 30 sec. in each mode with its patient port open to atmosphere to dry internal parts. CAUTION:

Ethylene oxide is not recommended. Sterilization using an ethylene mixture may cause small surface cracks to some of the plastic parts that may not be apparent to the user.

CAUTION:

Do not steam autoclave, immerse in liquid or gas sterilize the Vacuum Regulators. This may damage the unit.

CAUTION:

If Vacuum Regulator becomes contaminated internally, warranty is voided. Do not send Vacuum Regulator back to the manufacturer. Follow your facilities procedures for handling contaminated products.

Recommended Maintenance The following are recommended maintenance steps that should be taken after each patient: 1. Clean the exterior of the Vacuum Regulator with a solution of a diluted mild detergent. 2. Make sure all secondary apparatus such as canisters and tubing are thoroughly cleaned. 3. Inspect the bacteria filter. If it has been contaminated replace with a new one. 4. Inspect the overflow safety trap to make sure it is free of any restrictions.

Product Disposal Digital Product Only: T  he batteries and circuit board are not suitable for regular trash disposal. Follow local guidelines for disposal of other components. Device may contain bio-hazardous material and should be disposed of properly. Follow local guidelines for disposal of bio-hazardous material.

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

Replacement Parts VR-AG-100MM-WL

Analog Gauge with Lens 100 mmHg

VR-AG-160MM-WL

Analog Gauge with Lens 160 mmHg

VR-AG-300MM-WL

Analog Gauge with Lens 300 mmHg

VR-DG-100MM

Digital Gauge with Lens 100 mmHg

VR-DG-160MM

Digital Gauge with Lens 160 mmHg

VR-DG-300MM

Digital Gauge with Lens 300 mmHg

VR-MODULE

Regulating Module Assembly

VR-ORING-KIT-PI

1 Set of O-Rings, Gaskets and Filters for all Pediatric & Neonatal Models (PI, PP & NI, NN)

VR-ORING-KIT-CI

1 Set of O-Rings, Gaskets and Filters for Continuous/Intermittent Models (CI & I2)

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Amvex Continuous/Intermittent Vacuum Regulator Operating & Maintenance Manual

WARRANTY This Product is sold by Ohio Medical LLC., (the “Company”) under the express terms of the warranty set forth below. For a period of THIRTY SIX (36) MONTHS (or for a period of ONE HUNDRED AND TWENTY (120) MONTHS in North America ONLY) from the date the Company ships this Product to the customer, but in no event for a period of more than three years from the date of original delivery by the Company to an authorized dealer, this Product, other than its expendable parts (e.g., batteries for Digital Gauge) is warranted to be free from functional defects in materials and workmanship and to conform in all material respects to the description for the Product contained in this operation manual, if this Product is properly operated under conditions of normal use, regular periodic maintenance and service is performed and repairs are made in accordance with this operation manual. The warranty period for all expendable parts of the Product is sixty (60) days from the date the Company ships the Product to the customer. The foregoing warranty shall not apply if the Product has been repaired or altered by anyone other than the Company or an authorized dealer; or if the Product has been subjected to abuse, misuse, negligence, or accident. The Company reserves the right to stop manufacturing any product or change materials, designs, or specifications without notice. This warranty is extended to only the initial customer with respect to the purchase of this Product directly from the Company or an authorized dealer as new merchandise. Dealers are not authorized to alter or amend the warranty of any Product described in this agreement. Any statements, whether written or oral, will not be honored or be made part of the agreement of sale. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THE COMPANY SHALL NOT BE LIABLE FOR INCIDENTAL, COLLATERAL, CONSEQUENTIAL, OR SPECIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, OR LOSS OF USE. THE COMPANY’S LIABILITY, IN THE AGGREGATE, SHALL NOT EXCEED THE PURCHASE PRICE OF THE PRODUCT. In order to file a warranty claim, customer is required to return Product prepaid to the Company at 1111 Lakeside Drive Gurnee, IL 60031 USA. As determined at the sole discretion of the Company, Products which qualify under the warranty will be repaired or replaced, at the Company’s option, and returned to customer via ground delivery at the Company’s expense. All claims for warranty must first be approved by Ohio Medical Customer Service Department: ([email protected] or 866.549.6446). Upon approval the customer service department will issue an RMA number. An RMA must be obtained prior to commencement of any warranty claim.

Ohio Medical LLC 1111 Lakeside Drive Gurnee, IL 60031 USA +1 866 549 6446 www.ohiomedical.com

2797

®

EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands

AUSTRALIAN SPONSOR: EMERGO AUSTRALIA Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia

© 2020 Ohio Medical LLC. This document contains information that is proprietary and confidential to Ohio Medical LLC. Use of this information is under license from Ohio Medical LLC. Any use other than that authorized by Ohio Medical LLC is prohibited. Ohio Medical, the Ohio Medical logo, Amvex, and the Amvex logo are registered trademarks of Ohio Medical LLC.

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