Vacuum Regulator Push-To-Set Intermittent Suction Unit Instructions for Use Rev 10

Table of Contents Safety Instructions...2 Intended Use...2 Receiving/Inspection...2 User Responsibility...2 Definitions...3 Specifications...5 Regulator Identification...6 Operation...7 Pre-use Checkout Procedure...9 Patient Set-up...9 Cleaning and Disinfection...10 Troubleshooting...10

Safety Instructions

This manual provides you with important information about the Push-To-SetTM Intermittent Suction Unit (PTSISU). To ensure the safe and proper use of this device, READ and UNDERSTAND all of the safety and operating instructions. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS, OR HAVE ANY QUESTIONS, REFER TO SERVICE MANUAL, CONTACT YOUR SUPERVISOR, DEALER OR THE MANUFACTURER BEFORE ATTEMPTING TO USE THE DEVICE.

Intended Use:

The vacuum regulator is intended to be used in the medical facility as a means to evacuate media (i.e. fluids) from the body. DO NOT use this vacuum regulator for anything other than its intended use.

Receiving / Inspection:

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

User Responsibility

This Product will perform as described in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective product should not be used. Parts that are broken, missing, worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, see the Ohio Medical service manual for service or repairs to this product. For service advice, Ohio Medical recommends that a telephone request be made to the nearest Ohio Medical Regional Service Center. This product and any of its parts should only be repaired using written instructions provided by Ohio Medical or by Ohio Medical trained personnel. The Product must not be altered without the prior written approval of Ohio Medical’s Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohio Medical. Failure to follow these instructions may cause damage to the patient, user and/or vacuum regulator. AAA A 12345

2

This alpha character indicates the year of product manufacture and when the serial number was assigned; “L” = 2007, “M” = 2008, “N” = 2009, etc. “I” and “O” are not used.

8700-0009-000 (Rev. 10)

Definitions WARNING CAUTION Note Important |O|O (INT) | (CONT) O (OFF)

= possible injury to patient or operator = possible damage to equipment = Provides additional information to clarify a point in the text. = Similar to a note but of greater emphasis = intermittent; cycles ON and OFF = continuous, ON = OFF



= Consult Instructions for Use = Serial Number = Manufacturer

Abbreviations in Inch ISU Intermittent Suction Unit kPa Kilo pascals (kPa x 7.50 = 1 mmHg) mmHg Millimeters of mercury (mmHg x 0.133 = kPa) mm Millimeters mL Milliliters °C Degrees Celsius °F Degrees Fahrenheit

N-m ft-lb in-lb DISS NPTF NEO PED PTS PTFE

Newton-Meter (N-m x 0.737 = ft-lb) Foot-Pound Force (ft-lb x 1.356 = N-m) Inch-Pound Force (ft-lb x 12 = in-lb) Diameter Index Safety System National Pipe Thread Female (USA) Neonatal Pediatric Push-To-Set™ Polytetrafluoroethylene

WARNINGS The Pre-Use Checkout Procedure must be performed before using the equipment on each patient. If the regulator fails any part of the Pre-Use Checkout Procedure, it must be removed from service and repaired by qualified service personnel. Do not use this device in the presence of flammable anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presence of these agents. This device is to be used only by persons who have been adequately instructed in its use. Factory settings may be impacted during transport therefore, the unit’s timing cycle should be checked prior to initial use and adjusted if necessary (see PTS-ISU Service Manual 7/Service Checkout Procedure, Section 7.6 Timing Cycle Adjustment). To reduce service personnel exposure to hazardous contamination, clean and disinfect all suction equipment before disassembly. To reduce transportation personnel and/or service personnel exposure to hazardous contamination, DO NOT ship any suction equipment that has been contaminated. Ohio Medical will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling. Connection to positive pressure sources such as oxygen and medical air, even momentarily, could injure the patient or operator. After patient use, regulators may be contaminated. Handle in accordance with your hospital’s infection control policy. To help prevent aspirate from entering the device, wall outlet and pipeline equipment, a safety trap should be attached prior to its use. Aspirate in the device, wall outlet and pipeline equipment may impair its operations. The use of the safety trap and suction filter will help prevent this and extend the life of suction equipment. 8700-0009-000 (Rev. 10)

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Definitions CAUTIONS Connection to positive pressure sources such as oxygen and medical air, even momentarily, could damage the equipment. Detailed information for more extensive repairs is included in the service manual for users having proper knowledge, tools and test equipment, and for service representatives trained by Ohio Medical. The suction control knob must be completely pushed in to adjust the vacuum level. Failure to do so may damage the vacuum regulator. Not for field or transport use: The categories of Field and Transport Use are specifically defined in ISO 100793 “Field” means accidents or emergencies outside the hospital. “Transport” means use in ambulances, cars and airplanes. These situations may expose the equipment to uneven support, dirt, water, mechanical shock and temperature extremes. Ohio Medical suction equipment has not been tested to comply with the specific requirements of these categories. Do not use harsh chemical or cleaning solution. Do not spray cleaners directly onto suction regulators. Only use chemical recommended in this manual. Important: BATTERY LOW INDICATOR: 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.

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8700-0009-000 (Rev. 10)

Specifications Performance Adult Flow rate

Intermittent

8 LPM

Continuous

80 LPM

8 LPM 3

80 LPM

Neonatal 8 LPM

3

80 LPM3

0-16 LPM (Preset at 8 LPM) 15 seconds ON, 8 seconds OFF (± 3 seconds) Can be adjustable Starts in the ON cycle

Timing Positive Pressure Safety Relief Valve:

Pediatric

Located in the vacuum supply line to prevent pressurization of the patient connection by failed injector vacuum (Venturi) units, or inadvertent cross connection to pressured gases.

Gauge Accuracy

Analog1

Digital2

Adult

0-200 mmHg (0-26.7 KPA)

±5% Full-scale

±1% Full-scale

Pediatric

0-160 mmHg (0-21.3 KPA)

±5% Full-scale

±1% Full-scale

Neonatal

0-160 mmHg (0-21.3 KPA) 0-100 mmHg (0-13.3 KPA)

±5% Full-scale ±5% Full-scale

±1% Full-scale ±1% Full-scale

Physical Dimensions

6.5”H x 2.8”W x 4.8”D (16.5 cm x 7.1 cm x 12.2 cm)

Weight

20 oz (567 grams)

Battery Lithium

Two 2/3 AA batteries, 3.6V, 1.6 Ah, lithium

full scale deflection full range at 22°C 3 not adjustable, without fittings at full increase 1 2

ENVIRONMENTAL SPECIFICATIONS Operating Temperature Range

50 to 104ºF (10 to 40ºC)

Storage Temperature Range

-13 to 158ºF (-25 to 70ºC)

Operating and storage Relative Humidity

5 to 95% RH (Non-condensing)

Ingress Protection Ratings:

IP 20

8700-0009-000 (Rev. 10)

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Regulator Identification Push-To-SetTM Intermittent Suction Unit (PTS-ISU)  Vacuum Gauge/Analog

 Fitting/Patient Port (inlet)

 Mode Selector Switch

 Probe/Adapter Port (outlet)

 Suction Control Knob (Push-To-SetTM) Vacuum Gauge/Digital

 400 500

60 70

600

80

300 50



40

High Flow High Vacuum

200

30 20

90



100

10 100

700

- kP

a

Hg -mm ®



   

®

F H

F H

M

M

L

L

MEDICAL VACUUM

®



  

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The pediatric and neonatal models are identified by the Baby Icon on the front right when looking at the unit.

8700-0009-000 (Rev. 10)



Operation Equipment Setup Insert the adapter/probe into the vacuum wall outlet. If the regulator is mounted elsewhere, connect a vacuum supply hose between the regulator’s adapter/probe and the wall outlet. Use hospital-supplied suction tubing between the vacuum regulator and the collection container, as well as between the patient port of the collection container and the patient (minimum inside diameter is 6 mm [0.25 in]). An Ohio Medical high flow suction filter and/or overflow safety trap (OST) should be used between the collection container and regulator to prevent contamination of the regulator, wall outlet and pipeline system. ISO 10079-3 (Section 5.1.2) states that “the usable volume of the collection container shall not be less than 500 mL.” High Flow Suction Filters Description Disposable Hydrophilic Filter

Part Number 6730-0350-800 20 Pack

6730-0351-800 200 Pack

Disposable Hydrophobic Filter Tubing x Tubing nipple

6730-0570-800 3 Pack

6730-0571-800 10 Pack

6730-0572-800 50 Pack

Disposable Hydrophobic Filter 1/8 NPT x Tubing nipple

6730-0580-800 3 Pack

6730-0581-800 10 Pack

6730-0582-800 50 Pack

Tubing

6700-0005-300

Note: For proper installation of adapters/probe and fittings, see PTS-ISU Service Manual.

Attaching the Overflow Safety Trap (OST) CAUTION

To help prevent aspirate from entering the regulator, wall outlet and pipeline equipment, a safety trap should be attached prior to its use. Aspirate in the regulator, wall outlet and pipeline equipment may impair its operation. The use of a safety trap and suction filter will help prevent this and extend the life of suction equipment.

Locking Gland Fitting 1. Raise the sleeve and insert the safety trap into the regulator fitting. 2. Turn the trap clockwise about one and a half turns to engage the threads. The trap does not need to be screwed tight; an O-ring in the regulator fitting provides a vacuum seal. The trap should rotate freely to allow the desired nipple positioning.

 

3. Lower sleeve to lock trap in position.  Regulator  Sleeve  Safety Trap



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Operation DISS fitting 

1. Insert the safety trap into the regulator fitting. Situate the nipple in the desired position. 2. Turn the DISS wing nut clockwise to engage threads and tighten (there is no O-ring, so the vacuum seal depends on a tight connection).



 Regulator  Wing nut  Safety Trap



Mode Selection |O|O (INT) - suction is intermittent (cycled “ON” and “OFF”) and the suction level can be adjusted with the suction control knob when cycled “ON”.

O (OFF) - No suction is supplied to the patient.

I (CONT) - Suction is continuous and can be adjusted with the suction control knob.

Setting the suction level

1. Move the mode selector switch to | (CONT).

2. Push and rotate the suction control knob until the vacuum gauge indicates the required setting.

CAUTION: The suction control knob must be completely pushed in to adjust the vacuum level. Failure to do so may damage the vacuum regulator. 8

8700-0009-000 (Rev. 10)

Pre-Use Checkout Procedure Pre-Use Checkout Procedure WARNING

The Pre-Use Checkout Procedure must be performed before using the equipment on each patient. If the regulator fails any part of the Pre-Use Checkout Procedure, it must be removed from service and repaired by qualified service personnel.

Important: All tests must be performed with supply vacuum of 66.7 kPa (500 mmHg) minimum. Note:

Pediatric/Neonatal ISU Only: Rotate suction control knob fully clockwise (increase) to verify that the suction level does not exceed 135 mmHg ± 5 mmHg (18.0 kPa ± 0.7 kPa) on the pediatric model or 100 mmHg ± 5 mmHg (13.3 kPa ± 0.7 kPa) on the neonatal model. When maximum vacuum is reached, the safety relief valve will emit an audible pulse.

1. Move the mode selector switch to O (OFF). 2. Push and rotate the suction control knob one full turn clockwise (increase). 3. Release the suction control knob. The gauge needle should not move (reading should remain at zero on units with a digital gauge). 4. Move the mode selector switch to | (CONT). The gauge should indicate vacuum with suction port occluded. 5. Push and fully rotate the suction control knob counter-clockwise (decrease) until it stops. 6. Release the suction control knob. The gauge needle should move to zero and remain there. (Readout should be zero on the digital gauge.) 7. Push suction control knob and increase the suction to 90 mmHg (12.0 kPa) 8. Slowly release and push the suction control knob to create various flow rates through the regulator. Check that the suction level is maintained when the knob is fully pushed in. 9. Move the mode selector switch to |O|O (INT). Verify that the regulator works intermittently. Note: The PTS-ISU starts in the ON cycle. 10. Push the suction control knob and reduce the suction level to zero. 11. Set the mode selector switch to O (OFF).

Patient Setup 1.

Make sure the Pre-Use Checkout Procedure has been performed.

2.

Move the mode selector switch to | (CONT)

3.

Set the prescribed suction level by pushing and turning the suction control knob.

400 500

60 70

600

80

300 50

40

High Flow High Vacuum

200

30 20

90

10

100

100

700

- kP ®

a

Hg -mm

CAUTION: The suction control knob must be completely pushed in to adjust the vacuum level. Failure to do so may damage the vacuum regulator. 4.

Move the mode selector switch to O (OFF).

5.

Attach tubing from the vacuum regulator to the vacuum port of the collection container.

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Cleaning and Disinfection

Troubleshooting

Cleaning and Disinfection Routine cleaning of the regulator is recommended as a standard procedure after each use. Wipe all exterior surfaces with a solution of water and mild detergent and/or an approved cleaning solution. Should misuse occur resulting in accidental flooding of the regulator, the regulator may be sterilized after cleaning using ethylene oxide (ETO). See Section 4.2 (Sterilization) of the PTS-ISU service manual. After sterilization follow the service checkout procedures in Section 7.0 (Service Checkout Procedure) of the PTSISU service manual.

Approved Cleaning Solutions •

Sodium Hypochlorite 0.5% (Bleach): Mixture of 13 fl. oz. of bleach to 1 gallon (128 fl. oz.) tap water

•

Isopropyl Alcohol 70%

•

Hydrogen Peroxide 3%

•

Cavicide® Ready to use full strength

WARNING

After patient use, regulators may be contaminated. Handle in accordance with your hospital’s infection control policy.

Troubleshooting If the regulator does not operate and you have performed the Pre-Use Checkout Procedure, remove the regulator from service and refer to PTS-ISU service manual or refer servicing to qualified service personnel.

Timing Cycle Adjustment For timing cycle adjustment, refer to PST-ISU service manual, section 9.

Installation Procedure for Adapters/Probes and Fittings For adapter/probe installation, refer to PTS-ISU service manual, section 8.

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8700-0009-000 (Rev. 10)

Notes

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Notes

66

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Notes

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North America United States Customer Service, Distribution Center Technical Support, Sales and Service Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee, IL 60031 USA P: 866 549 6446 P: +1 847 855 0800 F: +1 847 855 6218

Ohio Medical Corporation Authorized Representative OxygenCare Ltd. 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland Tel: +353 1 2769700 Fax: +353 1 2764970

© 2014 Ohio Medical Corporation. All rights reserved This document contains information that is proprietary and confidential to Ohio Medical Corporation. Use of this information is under license from Ohio Medical Corporation. Any use other than that authorized by Ohio Medical Corporation is prohibited.

Ohio Medical, Ohio Medical Corporation, and the Ohio Medical Corporation Logo are registered trademarks and Push-To-Set is a trademark of Ohio Medical Corporation. Dow Corning is the registered trademark of Dow Corning Corporation. Vac Kote is a registered trademark of Ball Aerospace & Technology Corp. Loctite is a registered trademark of Henkel Corporation.

8700-0009-000 (Rev. 10)