Amvex VR-CIU2-F2D Istruzioni operative

OPERATING AND MAINTENANCE MANUAL

- CONTINUOUS / INTERMITTENT -

DIGITAL & ANALOG VACUUM REGULATOR

®1111 Lakeside Drive, Gurnee, IL 60031-4099 | Tel: 1.800.448.0770 | Fax: 847.855.6300

www.ohiomedical.com

25B East Pearce St., Richmond Hill, ON L4B 2M9 Canada | Tel: 905.764.7736 | Fax: 905.764.7743 | www.amvex.com

0413

Models Included:

DIGITAL (D) ANALOG (A)

VR-CIU2-F2D VR-CIU2-F2A

VR-I2U2-F2D VR-I2U2-F2A

VR-PIU2-F2D VR-PIU2-F2A

VR-PPU2-F2D VR-PPU2-F2A

VR-NIU2-F2D VR-NIU2-F2A

VR-NNU2-F2D VR-NNU2-F2A

Rx ONLY

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INTERMITTENT VACUUM REGULATOR PART IDENTIFICATION

Regulating Module Parts List:

A. Cap Screws (2pcs) G. Regulating Spring

B. Regulating Cap H. Stem

C. Stem Screw I. Regulating Body

D. Top Plate J. Body O-rings (2 pcs)

E. Diaphragm K. Stem O-ring

F. Support Plate

1. Face Assembly

2. Analog Lens

3. Gauge

4. Gauge O-rings (2pcs)

5. Selector Screw

6. Selector Face Plate

7. Selector Switch

8. Selector Gasket

9. Index ball

10. Index Spring

11. Back Body

12. Selector Plug

13. Selector Plug O-ring

14. Back Gasket

15. Back Plate

16. Cover Screws (4 pcs)

{

2 Mode Face Assembly

3 Mode Face Assembly

{

3 Mode

2 Mode Intermittent

17. Back Plate Screws (2 pcs)

18. Bottom Plate Screw

19. Orifice

20. Regulating Module

23. Pediatric Relief Screw

24. Pediatric Relief Body

25. Pediatric Relief Ball

26. Pediatric Relief O-ring

27. Intermittent Module

28. Chamber O-ring

0-200mmHg Gauge (Analog or Digital)

0-300mmHg Gauge (Analog or Digital)

0-160mmHg Gauge (Analog or Digital)

{

Pediatric

models only

(Standard, Pediatric & Neonatal Regulating Module)

22. Port Plug

21. Port O-rings (2 pcs)

O-ring

4. Gauge O-rings (2pcs)

5. Selector Screw

6. Selector Face Plate

7. Selector Switch

8. Selector Gasket

9. Index ball

10. Index Spring

11. Back Body

12. Selector Plug

13. Selector Plug O-ring

14. Back Gasket

15. Back Plate

16. Cover Screws (4 pcs)

{

3 Mode

2 Mode Intermittent

17. Back Plate Screws (2 pcs)

O-ring

3. Gauge

0-200mmHg Gauge (Analog or Digital)

0-300mmHg Gauge (Analog or Digital)

0-160mmHg Gauge (Analog or Digital)

{

0-200mmH

Gau

(

Analo

or Di

ital

)

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.

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.

Consult operating manual.

Symbol indicates the device complies with the requirements of Directive 93/42/EEC

concerning medical devices (on CE marked devices only).

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

This device is to be used ONLY by people who have been properly

trained on the operation of the device. Operation of this device is not to

be done if ﬂammable anesthetics are present due to the possibility of

explosion caused by static charge.

This product performs as explained in this manual as long as the assembly, use, repair and

maintenance are properly followed according to our instructions. Periodic review of this de-

vice 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. If any of the

above are noted, immediate repair / replacement is required. In compliance with the Amvex

Warranty, repair of this device is not to be performed by anyone other than a qualiﬁed profes-

sional and done in strict accordance to the written instructions provided by Amvex. If this

device is subject to improper maintenance, repair, use and/or abuse leading to malfunction

of the device, replacement is the sole responsibility of the user.

ATTENTION: Service of this device should ONLY be performed by properly trained

individuals.

This product contains magnetic, ferrous material that may affect the

result of an MRI. MR Conditional options may be available, contact your

Amvex sales representative at 1-866-462-6839 or 905-764-7736.

!MRI WARNING:

!WARNING:

0413

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.

Vacuum Regulator

Model Gauge Range Gauge Accuracy

Analog Digital

Continuous /

Intermittent 0 - 300 mmHg +/- 3% F.S. +/- 1% F.S. at 22ºC

0 - 200 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

Operating Instructions

ATTENTION: The operating and storage temperature for the regulator should reﬂect

typical environmental conditions of a medical facility environment.

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

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 Corporation vacuum hose assembly onto the

supply port of the suction regulator and the other end onto the vacuum source (i.e. wall outlet).

Suction tubing, provided by the hospital, is required between the patient and patient port of

the canister, as well as between the outlet port of the Vacuum Regulator and canister. 1/4”

connection tubing is recommended by NFPA®.*

(*National Fire Protection Association (NFPA 99-2002). Healthcare facilities pages 497-498. )

To prevent possible contamination of the regulator, a high ﬂow suction ﬁlter or an overﬂow

safety trap provided by Amvex is recommended between the regulator and the collection

canister.

NFPA recommends use of an overﬂow trap to protect the vacuum regulator outlet and

vacuum 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.

NOTE: REG mode is only available on the 3 mode models

Battery Low Indicator:

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 Amvex/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 Amvex/Ohio Medical Customer Service Representative for battery replacement.

Procedures Prior to Use List:

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: Increase the vacuum to -12 kPa (-90 mmHg)

Pediatric & Neonatal: 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.

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 (-100mmHg) 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.

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 WARRANTYWILL BE VOIDED if the canister overﬂows and

contaminates the Vacuum Regulator.

!WARNING:

Setup for Patient use:

Setting the Level of Vacuum for Patient use:

1. Move the selector switch to the “REG” position.

2. Kink the vacuum tubing.

3. Set the required vacuum level.

The vacuum tubing must be kinked to

ensure that the patient is not exposed

to a higher level of vacuum than what

is required.

4. Move the selector switch to the “OFF” position.

5. Attach the vacuum tubing to the vacuum canister.

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.

NOTE: The off time must be adjusted prior to the on time.

6. 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.

7. 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.

8. 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].

9. Amvex recommends that the user complete the Procedures Prior to Use List to assure

Vacuum Regulator is operating correctly.

OFF Needle Valve

ON Needle Valve

INTERMITTENT MODULE

CAUTION: To prevent stripping of the plastic

threads, ﬁrst turn the screw counterclockwise until

it drops into its original threading, the screw may

then be turned clockwise and tightened.

!WARNING:

Cleaning Instructions

1. Connect the supply port of the Vacuum Regulator to the patient port of a collection

canister.

2. Attach the vacuum port of the collection canister to a vacuum source.

3. Connect a hose from the patient port of the Regulator to be cleaned and place the other

end into a container 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 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.

+NOB

#ONTAINER WITH COLD STERILANT OR ALCOHOL

3UPPLY0ORT

-ODE3ELECTOR3WITCH

0ATIENT0ORT

To Vacuum Source

Mode Selector

Supply Port

Regulating Knob

Patient Port

Container with cold sterilizer or alcohol

Authorized Representative

in the European Union:

EC REP

Oxygen Care Ltd.

2 Holfeld Business Park

Kilmacanogue Co Wicklow

Ireland

Replacement Parts

VR-AG-100MM Analog Gauge with Lens 100mmHg

VR-AG-160MM Analog Gauge with Lens 160mmHg

VR-AG-200MM Analog Gauge with Lens 200mmHg

VR-AG-300MM Analog Gauge with Lens 300mmHg

VR-DG-100MM Digital Gauge with Lens 100mmHg

VR-DG-160MM Digital Gauge with Lens 160mmHg

VR-DG-200MM Digital Gauge 200mmHg

VR-DG-300MM Digital Gauge with Lens 300mmHg

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)

VR-I-MANUAL 03/14

2014

hio Medical

orporation. This document contains in

ormation that is proprietar

and con

ﬁ

dential to

hio Medical

orporation. Use o

his in

ormation is under license

rom

hio Medical

orporation. An

use other than that authorized b

hio Medical

orporation is prohibited.

Ohio Medical Corporation, the Ohio Medical logo, Amvex and the Amvex logo are registered trademarks of Ohio Medical Corporation. NFPA is a

egistered trademark of National Fire Protection Association Inc.

WARRANTY

This Product is sold by Amvex Corp., a Delaware corporation (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 OFANY 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 25B East Pearce Street,

Richmond Hill Ontario, L4B2M9 Canada. 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 byAmvex Corporations Customer Service Department: (customerservice@

amvex.com or 866-462-6839/905-764-7736). Upon approval the customer service department will issue a Return Goods

Authorization (RGA) number. An RGA must be obtained prior to commencement of any warranty claim.

Form No. 55024 (Rev.1) 2012 / Form No. 55021 (Rev.1) 2012

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