AMVEX VR-CIU2-F2D, VR-CIU2-F2A, VR-I2U2-F2D, VR-I2U2-F2A, VR-PIU2-F2D User manual

OPERATING AND MAINTENANCE MANUAL

0413

- CONTINUOUS / INTERMITTENT -

DIGITAL & ANALOG VACUUM REGULATOR

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

0413

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

®

1111 Lakeside Drive, Gurnee, IL 60031-4099 | Tel: [phone] | Fax: [phone]

www.ohiomedical.com

1

16

B

C

D

E

F

G

H

I

).scp2(J

K

{

M
g

nitalugeR

wercS p

a
C

.A

g

nita
lu

g

eR .B

ercS met

S

.C

etalP poT .D

mga
r

hpaiD .E

a

l
P

tr
op

pS
F

)scp2( A

17

16

15

14

17

16

13

12

11

Pediatric

16

18

10

9

8

{

models only

7

6

28

5

26

22

25

19

20

24

23

21

27

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

INTERMITTENT VACUUM REGULATOR PART IDENTIFICATION

18. Bottom Plate Screw

2 Mode Face Assembly

(Standard, Pediatric & Neonatal Regulating Module)

19. Orifice

20. Regulating Module

3 Mode Face Assembly

{

0-200mmHg Gauge (Analog or Digital)

22. Port Plug

21. Port O-rings (2 pcs)

23. Pediatric Relief Screw

24. Pediatric Relief Body

25. Pediatric Relief Ball

26. Pediatric Relief O-ring

27. Intermittent Module

28. Chamber O-ring

3 Mode

2 Mode Intermittent

{

0-300mmHg Gauge (Analog or Digital)

0-160mmHg Gauge (Analog or Digital)

{

4

3

2

1

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

2

14. Back Gasket

15. Back Plate

16. Cover Screws (4 pcs)

17. Back Plate Screws (2 pcs)

IMPORTANT: SAFETY INSTRUCTIONS

0413

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.

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.

!

0413

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

WARNING:

!

trained on the operation of the device. Operation of this device is not to
be done if fl ammable 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 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. 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 qualifi ed 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.

MRI WARNING:

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.

3

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

Continuous /
Intermittent

Pediatric Continuous /
Intermittent

Neonatal Continuous /
Intermittent

Gauge Range Gauge Accuracy

Analog Digital

0 - 300 mmHg +/- 3% F.S. +/- 1% F.S. at 22ºC
0 - 200 mmHg +/- 3% F.S. +/- 1% F.S. at 22ºC

0 - 160 mmHg +/- 3% F.S. +/- 1% F.S. at 22ºC

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 refl ect
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

.*

To prevent possible contamination of the regulator, a high fl ow suction fi lter or an overfl ow
safety trap provided by Amvex is recommended between the regulator and the collection
canister.

NFPA recommends use of an overfl ow 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 the battery low icon is illuminated on the digital gauge, an
Amvex representative should be contacted for battery replacement.

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

4

Procedures Prior to Use List:
The following tests are recommended prior to use on each patient.

WARNING:

!

If the Vacuum Regulator does not pass one or more of the following tests,
it should be evaluated, repaired and/or replaced by a qualifi ed 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

WARNING:

!

“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 overfl ows and
contaminates the Vacuum Regulator.

5

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.

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.

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 fi rmly 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
Vacuum Regulator is operating correctly.

complete the Procedures Prior to Use List to assure

CAUTION: To prevent stripping of the plastic

threads, fi rst turn the screw counterclockwise until

it drops into its original threading, the screw may

then be turned clockwise and tightened.

INTERMITTENT MODULE

OFF Needle Valve

ON Needle Valve

6

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.

-ODE3ELECTOR3WITCH

Mode Selector

3UPPLY0ORT

Supply Port

Regulating Knob

+NOB

0ATIENT0ORT

Patient Port

Container with cold sterilizer or alcohol

To Vacuum Source

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 fi lter. If it has been contaminated replace with a new one.

4. Inspect the overfl ow safety trap to make sure it is free of any restrictions.

7

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)

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 THIR TY 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 specifi cations 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 fi le 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 fi rst be approved by Amvex 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.

2012 Ohio Medical Corporation. This document contains information that is proprietary and confi dential to Ohio Medical Corporation. Use of
his information is under license from Ohio Medical Corporation. Any use other than that authorized by Ohio Medical Corporation is prohibited.
hio Medical Corporation, the Ohio Medical logo, Amvex and the Amvex logo are registered trademarks of Ohio Medical Corporation. NFPA is a

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

egistered trademark of National Fire Protection Association Inc.

Authorized Representative
in the European Union:

EC REP

Oxygen Care Ltd.
2 Holfeld Business Park
Kilmacanogue Co Wicklow
Ireland

VR-I-MANUAL 07/12

8