Ohio North American ISU, International ISU User manual

Intermittent Suction Units (ISU)
Service Manual
North American
ISU
International
ISU
User Responsibility
This Product will perform in conformity with the description thereof contained in this 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 malfunc­tioning Product should not be used. Parts that are broken, missing, plainly worn, destroyed or con­taminated, should be replaced immediately. Should such repair or replacement become necessary, Ohio Medical recommends that a telephonic or written request for service advice be made to the nearest Ohio Medical Service Offi ce. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohio Medical, or altered without the prior written
Technical Competence
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. No repairs should ever be undertaken or at­tempted by anyone not having such qualifi cations.
approval of Ohio Medical’s Safety 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 alterations by anyone other than Ohio Medical.
Important: Federal law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed medical practitioner. This device is to be used only by persons who have been adeuately instructed in its use.
Important: This document is not to be reproduced in any manner, nor are the contents herein to be disclosed to anyone without the express authoriza­tion of Ohio Medical Corporation, Gurnee, IL USA.
Genuine replacement parts manufactured or sold by Ohio Medical must be used for all repairs.
Read completely through each step in every pro­cedure before starting the procedure; any excep­tions may result in a failure to properly and safely complete the attempted procedure.
Abbreviations Used In This Manual
in Hg in ISU kPa LPM mm Hg mm oz | (CONT) |O|O| (INTER) O (OFF) P-P °C °F N-m ft-lb DISS OES NCG BOC NPT NPTF MPTS I.D. gal. PTFE NG
Inches of mercury Inch Intermittent Suction Unit Kilo pascals (kPa x 7.50 = mm Hg) Liters per minute Millimeters of mercury (mm Hg x .133 = kPa) Millimeters Ounces Continuous (On) Intermittent Off Posi-Pulse Degrees Celsius Degrees Fahrenheit Newton-Meter (N-m x .737 = ft-lb) Foot-Pound Force (ft-lb x 1.356 = N-m) Diameter Index Safety System Oxequip Suction National Compressed Gases (Chemetron) British Oxygen Corporation National Pipe Thread (USA) National Pipe Thread Female (USA) Multi-Purpose Therapy Stand Inner Diameter gallon
®
Tefl on Naso - Gastric
Table of Contents
1/Precautions .................................................... 1-1
1.1 Defi nitions ..................................................... 1-1
1.2 Warnings ......................................................1-1
1.3 Cautions .......................................................1-2
2/Scope .............................................................. 2-1
2.1 North American Vacuum Regulators. ........... 2-1
2.2 English Vacuum Regulators .........................2-1
2.3 French Vacuum Regulators .......................... 2-2
2.4 Spanish Vacuum Regulators ........................ 2-2
3/Description and Specifi cations .................... 3-1
3.1 Description ...................................................3-1
3.2 Specifi cations ...............................................3-2
4/Operation........................................................ 4-1
4.1 Equipment Set-up ......................................... 4-1
4.2 Mode Selection ............................................. 4-2
4.3 Setting the Suction Level .............................. 4-2
4.4 Pre-Use Checkout Procedure ...................... 4-3
4.5 Patient Set-up ............................................... 4-6
4.6 Setting the Timing Cycles ............................. 4-7
4.7 Setting the Intermittent Mode Flow
Rate .............................................................. 4-8
5/Cleaning and Sterilization ............................. 5-1
5.1 Cleaning ....................................................... 5-1
5.1.1 Routine Exterior Cleaning .................. 5-1
5.1.2 Internal Component Cleaning.............5-1
5.2 Sterilization ................................................... 5-1
6/Troubleshooting ............................................6-1
7/Service - Disassembly and Assembly ......... 7-1
7.1 Service Tools and Equipment ....................... 7-1
7.2 ISU and Posi-Pulse ISU ...............................7-1
7.2.1 Disassembly ....................................... 7-1
7.2.2 Assembly ............................................ 7-4
7.3 Regulator Module ......................................... 7-5
7.3.1 Disassembly ....................................... 7-5
7.3.2 Assembly ............................................ 7-6
7.4 Timing Valves ............................................... 7-6
7.4.1 Disassembly ....................................... 7-6
7.4.2 Assembly ............................................ 7-6
8/Service Checkout Procedure........................ 8-1
8.1 Set-up ........................................................... 8-1
8.2 Leak Test - Supply Side ................................ 8-1
8.3 Flow Test ...................................................... 8-2
8.3.1 Continuous Mode Flow Test ............... 8-2
8.3.2 Intermittent Mode Flow Test ............... 8-2
8.4 Gauge Test ................................................... 8-3
8.5 Regulation Test ............................................. 8-3
8.6 Timing Cycle Adjustment .............................. 8-3
8.7 Vacuum Build-up/Bleed-down
Test - Intermittent Mode ................................ 8-3
8.8 Posi-Pulse Test ............................................. 8-3
8.9 Bleed Test ..................................................... 8-4
8.10 Leak Test - Patient Side ............................. 8-4
9/Maintenance ................................................... 9-1
9.1 General Maintenance of Suction
Equipment .................................................... 9-1
9.2 Recommended Maintenance Schedule ....... 9-1
9.2.1 Maintenance Schedule ....................... 9-1
9.3 Repair Policy ................................................ 9-2
9.4 Technical Assistance .................................... 9-2
9.5 Return Instructions ....................................... 9-2
10/Ordering Information ................................. 10-1
10.1 Illustrated Parts ........................................ 10-1
10.2 Service Kits .............................................. 10-3
10.3 Fittings and Adapters ............................... 10-4
10.4 North American ........................................ 10-5
10.4.1 Regulator Options ........................ 10-5
10.4.2 Other Options ............................... 10-6
10.5 English Regulator Options .......................10-7
10.6 French Regulator Options ........................ 10-8
10.7 Spanish Regulator Options ...................... 10-9
10.8 English, French and Spanish
Other Options ........................................ 10-10
Appendix ...........................................................A-1
Installation procedure for Adapters/Probes
and Fittings. ........................................................A-1
i
Notes
ii
1/Precautions
1.1 Defi nitions
Note: A Note provides additional information to
clarify a point in the text. Important: An Important statement is similar to a
note but of greater emphasis. CAUTION: A CAUTION statement is used when
the possibility of damage to the equipment exists.
WARNING: A WARNING statement is used when the possibility of injury to the patient or the operator exists.
1.2 Warnings
The Pre-Use Checkout Procedure must be per­formed before using this 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 qualifi ed service personnel.
Connect the Vacuum Regulator to the vacuum source only. Connection to pressure sources even momentarily could injure the patient or operator and damage the equipment.
Always connect the regulator to the vacuum source and check its operation before attaching the patient connection.
The fi tting port of the regulator must be occluded when setting the prescribed suction level. This prevents the patient from receiving higher than required suction levels.
Do not use this device in the presence of fl amma- ble anesthetics. Static charges may not dissipate and possible explosion hazard exists in the pres­ence of these agents.
After patient use, regulators may be contaminated. Handle in accordance with your hospital’s infection control policy.
Clean and sterilize all multiple use suction equip­ment before shipment to ensure transportation per­sonnel and/or service personnel are not exposed to any hazardous contamination.
Clean and sterilize all multiple use suction equip­ment if contaminated before disassembly, to ensure service personnel are not exposed to hazardous contamination.
Following sterilization with ethylene oxide, parts should be quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material. Aerate parts for 8 hours
o
at 130 If the Vacuum Regulator is repaired or disassem-
bled in any manner, the Service Checkout Proce­dure must be performed before using the equip­ment on the patient.
The Posi-Pulse ISU must be mounted vertically for proper operation. The regulator may not operate correctly in any other position.
For proper Posi-Pulse operation, the Posi-Pulse ISU’s “On” and “Off” timing cycles must be a mini­mum of 10 seconds.
If the fl ow control valve is rotated fully clockwise, the ISU and Posi-Pulse ISU will not cycle in the intermittent mode. Drainage will cease.
When using the Posi-Pulse ISU with a Posi-Pulse Device, avoid using suction over 200 mm Hg/26 kPa or Posi-Pulse operation may not allow effective drainage.
It may be possible to set the vacuum limit to zero. If there is no suction present, rotate set screw counterclockwise and/or check Chapter 6/Trouble­shooting.
If the screws on the timing valves are turned all the way clockwise, the ISU and Posi-Pulse ISU will not cycle.
F (54oC).
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1/Precautions
1.3 Cautions
A supply vacuum of less than 15 in Hg/51 kPa (380 mm Hg) may impair Posi-Pulse ISU and Posi-Pulse Device operation.
Cleaning the gauge may result in damage. Do not lubricate any internal components of the
regulator module. Do not over-tighten the timing valve stem. Needle
portion of the valve may be damaged. Do not steam autoclave or liquid sterilize the ISU or
Posi-Pulse ISU. Severe impairment to the opera­tion of the regulator will result. The only acceptable method of sterilization is with gas (ethylene oxide).
Do not use any 1Loctite® products to seal the fi tting and adapter port threads (or products which con­tain Methacrylate Ester as an active ingredient).
Only competent individuals trained in the repair of this equipment should attempt to service it.
Sterilization with ethylene oxide mixtures may cause crazing (minute superfi cial cracking) of some plastic parts. Crazing will be more pronounced when mixtures containing 2Freon® are used.
The cap screws can strip the regulator module housing threads if they are screwed in too tight.
The gauge assembly must be handled with utmost care to retain its precision. If the lens is removed, do not rest the gauge on its face.
To help prevent aspirate from entering the regula­tor, as a result of misuse, an Overfl ow Safety Trap and suction fi lter, should be attached prior to its use. Aspirate in the regulator will impair the opera­tion. The use of the Overfl ow Safety Trap and suc- tion fi lter will help prevent this and extend the life of the suction equipment.
To prevent stripping the plastic threads, place the screw in the hole and turn counterclockwise until it drops into the original threads. Tighten screw.
Use of lubricants other than recommended, may degrade plastic or rubber components.
Not for Field or Transport Use**
1
Loctite is the registered trademark of the Loctite Corporation.
2
Freon is the registered trademark of the DuPont Co.
**The categories of Field and Transport Use are specifi cally defi ned in
ISO 10079-3 (BS 7259: Part 2). "Field" means use at accidents or emergencies outside a hospital. "Transport" means use in ambulanc­es, cares and airplanes. These situations may expose the equipment to uneven support, water, dirt, mechanical shock and temperature extremes. Ohio Medical suction equipment has not been tested to
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2/Scope
This service manual contains service, maintenance and parts information on four models of the ISU and four models of the Posi-Pulse ISU.
North American (2) English (2) French (2) Spanish (2)
2.1 North American Vacuum Reg­ulators
Note: Part numbers given are for Vacuum Regula­tors without fi ttings or adapters.
Posi-Pulse ISU 6700-1252-900
2.2 English Vacuum Regulators
Note: Part numbers given are for Vacuum Regula­tors without fi ttings or adapters.
ISU 6700-1251-900
Posi-Pulse ISU 6700-1256-900
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ISU 6700-1253-900
2/Scope
2.3 French Vacuum Regulators
Note: Part numbers given are for Vacuum Regula­tors without fi ttings or adapters.
Posi-Pulse ISU 6700-1257-900
2.4 Spanish Vacuum Regulators
Note: Part numbers given are for Vacuum Regula­tors without fi ttings or adapters.
ISU 6700-1254-900
Posi-Pulse ISU 6700-1258-900
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ISU 6700-1255-900
3/Description and Specifications
3.1 Description
WARNING: Do not use this device in the pres­ence of fl ammable anesthetics. Static charges may not dissipate and possible explosion haz­ard exists in the presence of these agents.
The Intermittent Suction Unit (ISU) and Posi-Pulse Intermittent Suction Unit (Posi-Pulse ISU) are dual purpose Vacuum Regulators which provide either intermittent or continuous suction. They can be used for N.G. (intermittent) or pharyngeal/tracheal (continuous) suctioning throughout the hospital.
On the Pediatric ISU, the maximum vacuum limit is factory present to 135 mm Hg and the limit may be adjusted between 80 and 150 mm Hg. It also has a positive pressure relief. The low gauge and the baby icon on the cover distinguish it from the standard ISU.
Each unit contains a regulator module to regulate and adjust suction, a vacuum gauge which indi­cates suction supplied, a patented Unilogic Mod­ule to silently and reliably switch suction on and off, and timing valves which select and adjust the length of the on and off cycles.
The Posi-Pulse ISU also contains a pause module and Posi-Pulse attachment port. It can be used with or without a disposable Posi-Pulse Drainage Assist Device®.
In use, the vacuum source is connected through the regulator module which functions as an au­tomatic valve. Rotating the suction control knob adjusts the position of the regulator module and selects a predetermined level of suction.
During use, as the fl ow requirement increases, the valve automatically opens to maintain suction at the preset level. Conversely, when the fl ow require- ment decreases, the valve automatically closes to maintain suction at the preset level. The same mechanism compensates for changes in supply vacuum to automatically maintain the pre-set suc­tion level.
Note: Posi-Pulse Drainage Assist Device istered trademark of The BOC Group, Inc.
1. Suction Control Knob - Allows easy adjustment of suction to the patient.
2. Mode Selector Knob - Allows quick and easy mode changes.
Note: In the text of this manual, the international
graphic symbol for the intermittent mode nor­mally written as:
will be written as |O|O|.
®
is a reg-
|
O
|
O
|
Pause Module Cover *
Vacuum Gauge
Adapter
Mode Selector Knob
Fitting Port
Suction Control Knob
* Note: Posi-Pulse ISU ONLY.
Port
Posi-Pulse Attachment Port *
Front and Side View
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3/Description and Specifications
a. IOIOI (INTER) or IOIOI P-P (INTER) - Suc-
tion is intermittent (cycles on and off) and the suction level can be adjusted with the suction control knob. This is the selection used for Posi-Pulse N.G. Drainage System operation.
When used as an Intermittent Suction Unit,
both the “On” and “Off” timing cycles are in­dependently adjustable within a range of 3 to 30 seconds. These are pre-set at the factory at a supply vacuum of 450 mm Hg/60 kPa to provide approximately 15 seconds “On” and 8 seconds “Off” for the ISU and 15 seconds
“On” and 15 seconds “Off” for the Posi-Pulse ISU. If the supply vacuum is different, the timing cycles will vary. Adjustment procedures are outlined in the Operations Section of this manual under the heading “Setting the Timing Cycles”.
b. O (OFF) - No suction is supplied to the pa-
tient.
c. I (CONT) - Suction is continuous and can be
adjusted with the suction control knob.
3. Vacuum Gauge - The suction level to the patient is displayed during use.
3.2 Specifi cations
Gauge: Accuracy: ±5% of full scale defl ection Flow Rates: | (CONT) Mode - 0 - 80 LPM without fi ttings at full
increase setting depending on supply vacuum and open air fl ow
|O|O| (INTER)/|O|O| P-P (INTER) Mode - 8 LPM with the suction control knob set to 120 mm Hg/16 kPa
Regulated Suction Range: 0 to 200 mm Hg/0 to 26 kPa Pediatric ISU: 0 to 150 mmHg/0 to 20 kPa
Pre-Set Timing Cycles: ISU (Intermittent Mode ONLY) On time cycle-15 seconds ± 3 seconds Note: The Pre-set timing cycles Off time cycle-8 seconds ± 3 seconds are set at a supply vacuum of 450 mm Hg/60 kPa. Posi-Pulse ISU On time cycle-15 seconds ± 3 seconds Off time cycle-15 seconds ± 3 seconds
Posi-Pulse Signal Line Pause: 6 seconds ± 4 seconds from the start of the OFF time cycle
Weight: (Less Fittings) ISU - 28 oz/794 grams Posi-Pulse ISU - 31 oz/879 grams Pediatric ISU: 28 oz/794 grams
Dimensions: (Less Fittings) Height: 6.6 inches/168 mm Width: 3.5 inches/89 mm Depth: 4.8 inches/121 mm
Latex tubing, 0.25 in (6.4 mm) I.D. X 0 to full vacuum 12 in (30 cm) supplied: Flow dependent on source and setup
Disposable tubing (Available 0 to full vacuum separately in some markets; Flow dependent on source and setup 6 mm I.D. X 450 mm, 750 mm and 2 M) to connect regulator and collection bottle
Disposable Suction Filter: 0 to full vacuum 0 to 100 Lpm @ 650 mmHg (-87 kPa)
Environmental Specications Operating Temperature Range: 40oF (4oC) to 120oF (49oC) Storage Temperature Range: 0oF (-18oC) to 160oF (71oC) Operating and Storage Relative Humidity: 5 to 95%
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4/Operation
4.1 Equipment Set-up
WARNING: Connect the Vacuum Regulator to the vacuum source only. Connection to pres­sure sources even momentarily could injure the patient or operator and damage the equipment.
WARNING: Always connect the regulator to the vacuum source and check its operation before attaching the patient connection.
WARNING: The Posi-Pulse ISU must be mounted vertically for proper operation. The regulator may not operate correctly in any other position.
CAUTION: To help prevent aspirate from enter- ing the regulator, an Overfl ow Safety Trap and suction fi lter should be attached prior to its use. Aspirate in the regulator will impair the operation. The use of the Overfl ow Safety Trap and suciton lter will help prevent this and extend the life of the suction equipment.
If the regulator is equipped with an adapter for wall outlets, insert the adapter into the vacuum wall outlet. If the regulator is mounted elsewhere, con­nect a vacuum supply hose between the regulator’s adapter port and the wall outlet. Connect the Collection Bottle’s vacuum port to the regulator’s tting or Overfl ow Safety Trap with the appropriate vacuum tubing.
Note: For proper installation of Adapters/Probes and Fittings see Appendix.
For standard ISU operation, mount the Collection Bottle above the patient.
For optimal Posi-Pulse system operation, mount the Collection Bottle at or below patient level.
Connect the collection bottle's vacuum port to the regulator's fi tting port or Overfl ow Safety Trap with the appropriate suction fi lter and vacuum tubing.
Hospital-supplied suction tubing must be used between the catheter and the collection bottle. Recommended minimum inside diameter is 0.25 in (6 mm).
An Ohio Medical High Flow Disposable Filter should be used between the Collection Bottle and the Vacuum Regulator to prevent contamination of the regulator.
ISO 10079-3 (BS 7259: Part 2) states that "the us­able volume of the collection container shall be not less than 500 ml (section 5.1.2).
Suction Filters - Hydroiphilic
Pkg of 20 .........................................6730-0350-800
Pkg of 200 .......................................6730-0351-800
Suction Filters - Hydrophobic Filter Tubing x 1/8" NPT x tubing nipple tubing nipple
Pkg of 3 6730-0570-800 6730-0580-800 Pkg of 10 6730-0571-800 6730-0581-800 Pkg of 100 6730-0572-800 6730-0582-800
Vacuum Regulator
Disposable Suction Filter
Overfl ow Safety Trap
Vacuum Port
Connective Tubing
Patient Port
Collection Bottle
Equipment Set-up
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4/Operation
4.1.1 Attaching the Safety Trap
CAUTION To help prevent aspirate from entering the regulator, wall outlet and pipeline system as a result of
Standard fi tting
1. Raise the sleeve and insert the trap into the regulator fi tting.
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 fi tting provides a vacuum seal. The trap should rotate freely to allow the desired tubing positioning.
3. Lower sleeve to lock trap in position.
misuse, an Overfl ow Safety Trap should be attached prior to its use. Aspirate in the regulator, wall outlet and pipeline system may impair their operation. The use of the Overfl ow Safety Trap and suc- tion fi lter will help prevent this and extend the life of suction equipment.
Regulator
Sleeve
DISS fi tting
1. Insert trap into the regulator fi tting. Situate the tubing 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
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4/Operation
4.2 Mode Selection
|O|O| (INTER) or |O|O| P-P (INTER) - Suction is intermittent (cycles on and off) and the suction level can be adjusted with the suction control knob. This is the selection used for Posi-Pulse system opera­tion.
O (OFF) - No suction is supplied to the patient.
IOIOI (INTER) or IOIOI P-P (INTER)
O (OFF)
| (CONT) - Suction is continuous and can be ad­justed with the suction control knob.
4.3 Setting the Suction Level
WARNING: The fi tting port of the regulator must be occluded when setting the prescribed suction level. This prevents the patient from receiving higher than required suction levels.
WARNING: When using the Posi-Pulse ISU with a Posi-Pulse Device, avoid using suction over 200 mm Hg/26 kPa or Posi-Pulse operation may not allow effective drainage.
CAUTION: A supply vacuum of less than 15 in Hg/51 kPa (380 mm Hg) may impair Posi-Pulse ISU and Posi-Pulse Device operation.
1. Turn the mode selector knob to | (CONT).
2. Clamp the connective tubing to occlude the fi t- ting port.
3. Rotate the suction control knob until the vacuum gauge indicates the required setting.
I (CONT)
I
(CONT)
Clamp
Setting the Suction Level
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4/Operation
4.4 Pre-Use Checkout Procedure
WARNING: The Pre-Use Checkout Procedure must be performed before using this 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 qualifi ed service personnel.
WARNING: Always connect the regulator to the vacuum source and check its operation before attaching the patient connection.
Before the vacuum regulator is used, it must be tested for correct operation as outlined below. All tests must be performed with the regulator in its normal (vertical) operating position and with a minimum supply vacuum of 19.7 in Hg/67 kPa (500 mm Hg).
1. Turn the mode selector knob to O (OFF). Rotate the suction control knob one full turn clockwise (increase). Clamp the connective tubing to oc­clude the fi tting port. The gauge needle should not move.
O
(OFF)
Clamp
2. Turn the mode selector knob to | (CONT). Rotate the suction control knob fully counterclockwise (decrease). Clamp the connective tubing. The gauge needle should not move.
Step 1
I
(CONT)
Clamp
Step 2
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4/Operation
3. Clamp Tubing
REGULATOR SETTING
Pediatric ISU Low: Increase the suction to 60 mmHg/8kPa
Pediatric ISU Only: Clamp tubing and rotate suc­tion control knob fully clockwise (increase). Check that vacuum reading on gauge is no higher than 160 mmHg/21 kPa to verify this is a limited unit.
Slowly open and close the clamped tubing to cre­ate various fl ow rates through the regulator. Check that the suction level is maintained when the tubing is clamped.
Clamp
Release Clamp
4. Turn the mode selector knob to |O|O| (INTER) or |O|O| P-P (INTER). Clamp the connective tub­ing.
For the ISU, ensure that the timing cycles are
approximately 15 seconds “On” and 8 seconds “Off” by observing the gauge needle.
For the Posi-Pulse ISU, ensure that the timing
cycles are approximately 15 seconds “On” and 15 seconds “Off” by observing the gauge needle.
I
O
I
(INTER)
O
I
Step 3
Clamp
Step 4
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4/Operation
5. For Posi-Pulse ISU ONLY with a Posi-Pulse Device
a. Connect the Posi-Pulse signal line (blue tub-
ing) to the attachment port.
b. Turn the mode selector knob to |O|O| P-P
(INTER).
c. Clamp the connective tubing.
I
PP
O
(INTER)
I
O
I
d. During the “On” cycle, ensure that the pistons
lift inside the Posi-Pulse Device’s clear cham­ber.
e. When the “Off” cycle begins, ensure that
there is a delay of 2 to 10 seconds before the pistons drop.
ON
Cycle
Posi-Pulse Device
OFF
Cycle
Clamp
6. Reduce the suction level to zero and turn the mode selector knob to O (OFF).
Step 5
O
(OFF)
Step 6
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