SSCOR INC
SSCOR BOARD Operating Instructions and Maintenance Manual Rev P Sept 2020
Operating Instructions and Maintenance Manual
16 Pages

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Operating Instructions & Maintenance Manual
BOARD
TM
Clearing The Airway Is Our #1 Priority
, INC. 11064 Randall Street Sun Valley, CA 91352 USA Tel 1+818-504-4054 www.sscor.com shop.sscor.com Email: [email protected] [email protected]
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Clearing The Airway Is Our #1 Priority
Caution-Notice 1. This suction system is for permanent installation in patient transport vehicles to be used exclusively by medical personnel trained in suctioning techniques and in the use of medical suction equipment. 2. Federal law restricts this device to sale, distribution, and use by, or on the order of a physician, emergency medical technician, or other medical practitioner. For use by medical personnel trained in suctioning techniques and in the use of medical suction equipment.
3. This manual is restricted to the discussion of the use and maintenance of this device. It does not attempt to discuss professional techniques in suctioning procedures. 4. Operator should be thoroughly familiar with these operating instructions before this device is used. 5. Do not use in the presence of flammable agents or anesthetics. 6. The SSCOR/board™ produces a powerful vacuum. Use the regulator to control vacuum as appropriate. 7. Observe gauge marking and pre-adjust the regulator for the anticipated procedure by occluding the patient tube with the HI-D® tip removed and the vacuum system running.
8. The mechanical shut-off valve in the canister lid will close down when canister is filled with fluids. If the vacuum shuts down, empty contents immediately or replace the canister with a new one. Spare canisters are available from SSCOR, Inc. or your dealer. 9. Use the canister in an upright position to keep fluids away from shut off valve and filter. A wet filter can close the system. Be sure the lid on the canister is tightened securely to prevent a loss of vacuum at a critical time. 10. Before testing for vacuum over -300mmHg look for an expiration date on the canister (where applicable) and change the canister if the canister has passed the expiration date to minimize the possibility of implosion, which can occur when a canister is aged or damaged. 11. Refer all servicing of electrical systems to qualified service personnel. Turn the SSCOR/board suction system off as soon as possible after use 12. If selecting alternate accessories make sure they meet specifications listed on page 9(tubing, canister and catheter) For the canister and tubing, ensure that you run the applicable test on pages 15-16. SSCOR/board Suction System for EMS Vehicles ©2015 HI-D and Big Stick are registered trademarks of SSCOR, Inc. 2
SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Table of Contents Caution-Notice General Description Symbol Description Model Description, Installation and Test Maintenance Troubleshooting and General Specifications Environmental Conditions and Warranty Accessory Specifications for Proper Selection by end user Templates-Model 22000, 23001, 22500, 22002 Templates-Model 23002, 25000 Installation Alert Verification for end users when selecting alternate Collection Canister Verification for end users when selecting alternate Patient (Suction) Tubing
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General Description The SSCOR/board suction system is a Hospital Grade medical vacuum system designed for EMS vehicles. It combines the safety and efficiency of a hospital system with the vehicular demand for rugged construction and durability. The SSCOR/board can be specified and purchased as part of a new vehicle or, it can retrofit to an existing vehicle. The SSCOR/board can be installed in its entirety or any one of the component groups described in this manual can be installed to enhance an existing system. SSCOR/board’s unrestricted vacuum system maximizes the airflow from the vacuum pump to the patient. The powerful vacuum provided by the vacuum pump is controlled by a vented regulator and can be monitored by an easy to read gauge. SSCOR/board’s durable canister holders accept most hospital grade, suction canisters. The canister holder provides years of durable service and helps to protect the collector from blows which could shatter the plastic vessel and render it useless. Room is provided for organized storage of patient tubing. The system can be powered by an installed 12V DC vacuum pump. It is designed to provide powerful, effective and reliable vacuum for suctioning procedures during patient transport. SSCOR/board exceeds performance standards for emergency vacuum when properly installed. The SSCOR/board system is available in the following component groups: Canister Holder, Panel Mount Regulator and Gauge, Retrofit Regulator and Gauge and Vacuum Pumps. 3
SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Description of Symbols SYMBOL
LOCATION
MEANING
Shipping Carton
Manufacturer
Shipping Carton
Date of Manufacturer
Shipping Carton
Authorized Representative in the European Community
Serialized Label / Shipping Label
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European Conformity
SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Model Description, Installation, and Test DESCRIPTION OF PARTS: Model #22000 Stainless Steel Panel Mount Regulator Part # 22015
Description Regulator
Part # 50150
22006
Gauge
60000-90
Description 10’ Tubing (5/16”ID x 9/16”OD ) 304.8cm Tubing (.79cm ID x 1.428cm OD) Mounting Screws (4 each)
22018
Faceplate
90154
Hose barb, straight 1/4” x 5/16” (2 each)
40000-9
Regulator Bracket
50161
Hose clamps (2 each)
INSTALLATION: Model #22000 Stainless Steel Panel Mount Regulator Use the template card to mark the hole placement in the panel 2-5/8" x 4-1/4" (6.67cm x 10.79cm) and mark the holes for the faceplate mounting screws. Connect the tubing from the vacuum pump to the hose barb on the regulator. Secure the tubing to the hose barb using the hose clamps. THE VACUUM SOURCE MAY BE CONNECTED TO EITHER SIDE OF THE REGULATOR. Run the tubing from the opposite hose barb on the regulator (secured with a hose clamp) to the suction canister.
DESCRIPTION OF PARTS: Model #25000 Stainless Steel Panel Mount Regulator (2-1/2” Gauge) Part # 22015
Description Regulator
Part # 50150
22025
Gauge
60000-90
Description 10’ Tubing (5/16”ID x 9/16”OD ) 304.8cm Tubing (.79cm ID x 1.428cm OD) Mounting Screws (4 each)
22019
Faceplate
90154
Hose barb, straight 1/4” x 5/16” (2 each)
40000-9
Regulator Bracket
50161
Hose clamps (2 each)
INSTALLATION: Model #25000 Stainless Steel Panel Mount Regulator (2-1/2” Gauge) Use the template card to mark the hole placement in the panel 3-1/3" x 4-1/2" (8.45cm x 11.43cm) and mark the holes for the faceplate mounting screws. Connect the tubing from the vacuum pump to the hose barb on the regulator. Secure the tubing to the hose barb using the hose clamps. THE VACUUM SOURCE MAY BE CONNECTED TO EITHER SIDE OF THE REGULATOR. Run the tubing from the opposite hose barb on the regulator (secured with a hose clamp) to the suction canister.
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Model Description, Installation, and Test DESCRIPTION OF PARTS: Model #23001 ABS Plastic Panel Mount Regulator Part #
Description
Part #
Description
22015
Regulator
50150
22006 23001 50007-87
Gauge Faceplate Regulator Label
60000-90 90154 50161
10’ Tubing (5/16”ID x 9/16”OD ) 304.8cm Tubing (.79cm ID x 1.428cm OD) Mounting Screws (4 each) Hose barb, straight 1/4” x 5/16” (2 each) Hose clamps (2 each)
INSTALLATION: Model #23001 ABS Plastic Panel Mount Regulator Use the template card to mark the hole placement in the panel 2-5/8" x 4-1/4" (6.67cm x 10.79cm) and mark the holes for the faceplate mounting screws. Connect the tubing from the vacuum pump to the hose barb on the regulator. Secure the tubing to the hose barb using the hose clamps. THE VACUUM SOURCE MAY BE CONNECTED TO EITHER SIDE OF THE REGULATOR. Run the tubing from the opposite hose barb on the regulator (secured with a hose clamp) to the suction canister. DESCRIPTION OF PARTS: Model #22500 Stainless Steel Retrofit Regulator Part #
Description
Part #
Description
22015
Regulator
50150
22006
Gauge
60000-90
3’ Tubing (5/16”ID x 9/16”OD ) 91.44cm Tubing (.79cm ID x 1.428cm OD) Mounting Screws (3 each)
22108
Faceplate
90154
Hose barb, straight 1/4” x 5/16” (2 each)
40000-9
Regulator Bracket
INSTALLATION: Model #22500 Stainless Steel Retrofit Regulator Use the template card to mark the hole placement for the mounting screws. The vacuum connections on your existing system can be connected to the SSCOR/board™ system, providing your system is producing over 30 LPM. If your system is reading less than 30 LPM, check the LPM at the pump head. The LPM at the pump head should be over 40 LPM. If the airflow meets specifications, connect the SSCOR/board regulator directly to the pump head with the tubing. Secure the tubing to the hose barb on the regulator. THE VACUUM SOURCE MAY BE CONNECTED TO EITHER SIDE OF THE REGULATOR. Run the tubing from the opposite hose barb on the regulator to the suction canister. If it is necessary to mount the regulator to a forward facing bulkhead, the gauge may be adjusted 1/4 turn to face the patient compartment after removing the bracket that holds the gauge in the forward position. FINAL TEST: Model #22000, Model 25000, Model 23001 and Model #22500 See the Daily Inspection and Operating Instruction section on page 7. 6
SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Model Description, Installation, and Test DESCRIPTION OF PARTS: Model #22002 Stainless Steel Canister Holder Part # Description 22001 Stainless Steel Canister Holder 43200 9/32" ID (.71cm) Patient Connecting Tube 44241 HI-D®, “The Big Stick”® Suction Tip 48041 1200ml/cc Disposable Canister 60000-91 Mounting Screws (3) DESCRIPTION OF PARTS: Model #23002 ABS Plastic Canister Holder Part # 43200 44241 48041
Description 9/32" ID (.71cm) Patient Connecting Tube HI-D®, “The Big Stick”® Suction Tip 1200ml/cc Disposable Canister
60000-90
Mounting Screws (3)
INSTALLATION AND TEST: Model #22002 and Model 23002 Canister Holder Assemblies Use the template card to mark the hole placement the for the mounting screws and attach the canister holder to the wall. Firmly place the canister lid on the canister and use the vacuum tubing to connect the regulator to the canister. Attach the patient connecting tube to the canister and test the operation per the daily inspection and operating instructions below. VACUUM PUMP PACKAGES: The SSCOR/board™ pump package includes a 12VDC, oil free, diaphragm pump, complete with accessories for easy installation. DAILY INSPECTION AND OPERATING INSTRUCTIONS Conduct these first two steps daily to assure the equipment performs to specifications. 1. Place a canister into the canister holder. Make sure the tubing from the regulator is connected to the “vacuum” port of the canister. Attach the patient connecting tube to the “patient” port of the canister. 2. Turn on the vacuum system and occlude the patient connecting tube. Observe the negative pressure gauge and adjust the regulator while the tubing is occluded. With the regulator in the maximum vacuum position, the negative pressure should exceed -500mmHg. Note: If the negative pressure does not register, check all fittings and connections for leaks including the caps on the canister lid and make sure the canister lid is properly seated to the body of the canister. 3. Install the appropriate suction tip to the distal end of the patient connecting tube. 4. Proceed to suction. 5. As soon as possible after use, turn the vacuum system off. The single use disposable canister, patient tubing and suction tip should be discarded according to local / regional / national requirements for the disposal of hazardous waste materials. 7
SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Maintenance Observe the following maintenance routine to ensure readiness at any time: 1. Test the SSCOR/board ™ system daily; See page 7. 2. Make sure the SSCOR/board is always clean and ready for use. 3. If the procedure produced an excessive quantity of fluids, check the vacuum line (1) for evidence of moisture. If the vacuum line between the pump and canister is moist, it is possible that fluids have reached the vacuum pump. See Disinfection Instructions. 4. For technical assistance, call +1 (818) 504-4054. Note: No part requires lubrication and lubricants should not be used.
Sanitation As soon as possible after use, the single use disposable canister, patient tubing and catheter should be discarded according to local / regional / national requirements for the disposal of hazardous waste materials. Clean the exterior of the SSCOR suction unit using a mild detergent and clear water by dampening a clean lint free cloth. Rinse using clear water and another damp clean lint free cloth to remove any detergent residue. NOTE: The hydrophobic filter in the canister helps to ensure that no moisture or particulate matter reaches the inside of the device. When fluids fill the canister, the positive (mechanical float) shutoff valve closes immediately, shutting the vacuum port off so as to prevent fluid from contacting the pump. The filter has been tested by the manufacturer (Bemis) to screen out aerosolized microorganisms and particulate matter at a bacterial efficiency rating of 99.99% DOP. The canister also has sidewall gradation marks starting at 100 ml/cc and at every 50 ml/cc up to 1200 ml/cc indicating the fill level of the canister. In the unlikely event that fluids may have reached the vacuum pump, read the disinfection section. Your engineering department will have to open the unit to check the condition of the pump. Do not reuse any single use disposable parts; do not submerge the device into any liquid, this will void the warranty and cause the device to malfunction.
Disinfection Use personal protective equipment such as gloves, a smock, and face and eye protection when handling units that are suspected to be contaminated. Disinfect the SSCOR/board system using a mild surface disinfectant, such as a 10:1 mixture of water and bleach. The unit is designed to suction contaminated fluids, which should be removed from the system I immediately after use. Part Collection Canister Patient Tubing HI-D® Stick Vacuum Pump Regulator
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Cleaning and Disinfecting Disposable item, re-use not permitted. Use new canister for each patient. Disposable item, re-use not permitted. Use new patient tubing for each patient. Disposable item, re-use not permitted. Use new HI-D Stick for each patient. Wipe with damp cloth or disinfectant wipe. Sterilization not permitted. Vacuum pump should be replaced if contaminated Wipe with damp cloth or disinfectant wipe. Sterilization not permitted. Regulator should be replaced if contaminated. The only foreseeable way fluids may reach the regulator is that the filter in the canister has been compromised or bypassed. SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Troubleshooting PROBLEM
POSSIBLE CAUSE
CORRECTIVE ACTION
Unit does not function when switch is in the “ON” position or fails to reach maximum pressure of –525mmHg
•
•
• • • •
Pump is sluggish
• •
System shuts down while suctioning heavy particulate matter
•
Unit fails to reach minimum negative pressure reading of below –50mmHg
•
•
Loose connections Vacuum Line Loose Canister Cracked Canister lid is not tight Thumb vent on suction tip is not occluded.
• • • •
Residual materials have collected in • the pump head Loose connections • Vacuum line clogged at canister lid Float valve has closed
• •
•
Inaccurate gauge Regulator clogged
•
•
Tighten connections Check connections Replace canister Re-secure canister lid Occlude with thumb Replace pump Check connections Remove connector or canister lid and loosen obstruction Loosen float valve, empty contents, or replace canister Replace gauge Replace regulator
If any other problems occur or if the recommended remedy fails to resolve the problem phone SSCOR, Inc. at +1(818) 504-4054.
General / Accessories* Specifications CHARACTERISTICS
SPECIFICATIONS
Vacuum Pump
12V DC., 3.0 A Clinical Airflow ≥ 30LPM Exceeds 525mmHg
Regulator
Controls negative pressure
Gauge
Accuracy ±2.5 Full Scale
*Collection Canister
1200cc/ml SSCOR part #48041
*Patient tubing
Vinyl tubing 9/32”ID x 72”L (7.1mm ID x 182.88 cm L) SSCOR Part #43200
*Suction Tip
HI-D® “Big Stick®” Large Bore Suction Tip with thumb control. SSCOR Part #44241
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Environmental Conditions CHARACTERISTICS
SPECIFICATIONS
Storage Temperature
−40 °C - +60 °C (-40° to 140°F).
Operational Temperature
−18 °C - +50 °C (-0.4° to 122°F).
Humidity
30% - 93% RH (non-condensing)
Warranty SSCOR warrants that each new product is free from defects in material and workmanship under normal use and service for a period of one year from date of purchase. If returned to SSCOR, we will arrange for repairs or replacement within the terms of the warranty. The product should be decontaminated and returned properly packaged and postage prepaid. Loss or damage in transit to the factory shall be at the purchaser’s risk. Please call +1 818-504-4054 for return authorization. Loss or damage in return shipment from SSCOR shall be at the purchaser’s risk.
The warranty shall not apply to any SSCOR product which has been repaired by anyone other than an authorized SSCOR representative, or altered in any way so as, in SSCOR’s judgment, to affect its safety or efficacy, nor which has been subject to misuse, negligence, or accident, nor which has had the serial number altered, effaced or removed. Neither shall this warranty apply to any SSCOR product which has been connected otherwise than in accordance with the instructions furnished by SSCOR. This warranty is in lieu of all other warranties expressed or implied and of all other obligations or liabilities on SSCOR’s part, and SSCOR neither assumes, nor authorizes any representative or other persons to assume for it, any other liability in connection with the sale of SSCOR products. This warranty gives you specific legal rights and you may also have other rights that vary from jurisdiction to jurisdiction. For countries where minimum warranty terms are determined by statute, the warranty term is the longer of the statutory period or the term listed above. Batteries, disposable items including collection canisters, patient tubing and catheters are excluded from this warranty.
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Accessory Specifications for Proper Selection by end user The following accessories can be selected based on the preference of the end user, however using SSCOR parts is strongly recommended. When selecting alternate accessories please ensure they meet the below specifications and that the Collection Canister and suction tubing are tested per page 15 and 16 of this manual. Patient Tubing: Vinyl Tubing 9/32”ID x 72”L (7.1mm ID x 182.88cm L), Single Use Disposable item and is CE Marked. SSCOR Part Number 43200. Collection Canister: The collection canister shall clearly show the level of contents in normal use. The usable volume shall not be less than 500ml and it shall be marked with its usable volume. The maximum volume of the canister shall not exceed 1100ml, it should be disposable and CE Marked. SSCOR Part Number 48041. Catheter: Single use Yankauer Suction Tip made of Medical Grade PVC and is DEHP Free , is compatible with patient tubing and suction canister. SSCOR Part Number 44241. Vacuum Pump: Can be electrical or engine driven as long as it is capable of creating a negative pressure of – 500mmHg at a minimum airflow rate of >30 LPM.
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Installation Alert
Installation Alert... for the SSCOR/board ™ Suction System The vacuum pumps installed in emergency vehicles generate enough airflow to supply one regulator. Air follows the path of least resistance. Therefore, two (or more) regulators on one vacuum line will render each other useless. The additional regulators merely act as pressure relief vents, diverting airflow away from the site where it is needed most. Negative pressure can fall to near zero in a system when one regulator is engaged in a low pressure procedure such as chest drainage or aspiration of fluids or is simply open to air. This can seriously impede the users ability to suction viscous fluids and food particles. Therefore... Install a dedicated vacuum pump for each vacuum outlet and/or SSCOR/board regulator provided in a vehicle. An ambulance or mobile intensive care unit with three regulators should have three separate vacuum pumps to insure that each vacuum outlet generates the necessary airflow. For use with electrical vacuum pumps only. Not to be used with engine vacuum aspirator systems. The SSCOR/board regulator does not function as a shut off valve. Thank you for your attention to this very important fact about onboard suction. Call or write for additional information about vacuum and airflow characteristics of SSCOR/board regulators, canisters and vacuum pumps. Additionally, we would be happy to provide you with an airflow meter to assist you in analyzing existing vacuum systems.
SSCOR, Inc.
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Verification for end users when selecting alternate Collection Canister Criteria
Verification
The collection canister shall clearly show the level of contents in normal use.
Visually Confirm
Suction equipment including suction equipment intended for transport use, the usable volume of the collection Visually Confirm Volume canister shall be not less than 500 ml
The air leaving the collection canister should pass through a filter or other means of protecting the pump from inadvertent contamination before entering the Visually Confirm that a filter is present vacuum pump. For reciprocating pumps, e.g. piston or diaphragm, depending on valves to control flow, a filter also protects against pump malfunction.
Collection Container
The collection canister shall be marked with its usable volume, in milliliters. For collection containers of 500 ml or greater, approximate indication of the volume shall Visually confirm that the graduation are present be given by graduations. The interval of the graduation should be not less than 50 ml and not more than 250 ml. Compliance shall be checked by the following test. Step 1) Place the collection container in a protective enclosure, for example a box or bag, at 20 °C to 25 °C. Step 2) Attach a vacuum source to the collection The Collection Canister shall not implode, crack or per- container opening. manently deform after being subjected to a pressure of Step 3) Evacuate the collection container to a vaceither 120 % of the manufacturer’s recommended maxi- uum of 95 kPa below atmospheric pressure. mum vacuum level or 95 kPa below atmospheric, which- Step 4) Hold the vacuum for 5 min, and then reever is less, for 5 min. lease. Step 5) Repeat the procedure once. Acceptance Criteria -- Visually inspect the collection container for deformation and/or implosion. Acceptance is based on no visual deformation and/ or implosion.
The inside diameter of the suction tubing connector (inlet port of the collection canister) shall be at least 6 Collection Canis- mm and the inside diameter of the suction tubing conter Inlet Port nection (inlet port) shall be equal to or larger than the inside diameter of the largest tubing size specified by the manufacturer.
NOTE 1 Suction performance may be markedly affected by the length and diameter of the suction tubing. NOTE 2 Because of the risk of misconnection, the internal diameter of the inlet port of the collection container should not be greater than 14 mm. NOTE 3 Special surgical situations such as suction lipectomy and suction curettage may require suction tubing and connectors of a larger bore.
Collection Canis- It shall not be possible to connect suction tubing to the Visually Confirm ter Exhaust Port exhaust port.
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SSCOR/Onboard Rev P (09/20)
Clearing The Airway Is Our #1 Priority
Verification for end users when selecting alternate Patient (Suction) Tubing Criteria
Verification
Suction tubing shall have an inside diame- IFU should ensure that if an alternate Suction Tubing is used it have ter of not less than 6 mm. at least a 9/32”ID (7.1mm ID)
Step 1) At a temperature of 20°C to 25°C, uncoil the suction tubing to its full length and plug one end to prevent any air flow through it. Step 2) Measure the inside and outside diameters of the suction tubing. Step 3) Attach a vacuum source to the other end of the suction tubing and adjust the level of vacuum to the maximum stated by the manufacturer, if applicable. If there is no disclosed maximum, adjust the vacuum to 60 kPa below atmospheric pressure. Step 4) Hold the vacuum for 5 min. Step 5) Measure the outside diameter of the suction tubing along its The degree of collapse of the suction tub- entire length with calipers at approximately every 10 % of the length ing shall be less than 0.5mm throughout its including any visible regions of collapse. entire length Step 6) Calculate the degree of collapse of the tubing from the following formula for each measurement point. Degree of collapse = Suction Tubing (OD Initial __OD Test)/ID Initial Step 7) Repeat the test while the suction tube is loosely coiled around a cylinder of diameter 100 mm. NOTE Narrow grooves may be cut in the cylinder to aid caliper measurement. Acceptance Criteria - "The degree of collapse shall not exceed 0.5mm in either test. For equipment intended for field and/or transport use and intended to operate from the floor, the length of suction tubing shall be such that the end-piece can be positioned at least 1,3 m above the floor.
Suction tubing supplied or recommended IFU should ensure that if an alternate suction tubing is used it have by the manufacturer shall have a minimum at least a 72”L (182.88 cm L) length of 1.3 m. The connectors for the suction tubing and the intermediate tubing shall be designed to facilitate correct assembly or clearly Visually Confirm marked to indicate correct assembly when all parts are mated.
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SSCOR/Onboard Rev P (09/20)