ven-view examination module users guide part of the osborn medical/acs ven-view vascular system

Ven-View Examination Module Users Guidepart of the Osborn Medical/ACS Ven-View Vascular System

Ven-View Examination Module Users Guide

• Table of Contents/Guide Sections

– 1-0: General Information• 1-1 Introduction• 1-2 Preparing to use the Product• 1-3 General Safety Notices• 1-4 User Safety• 1-5 Operator Requirements• 1-6 Mechanical, Electrical and Safety Certifications• 1-7 Warranty• 1-8 Return Policy

– 2-0: Description and Features• 2-1 Product Description• 2-2 Ven-View Examination Module Features

– 3-0: Specifications• 3-1 Dimensions, Capacity, Safety and Power

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• Table of Contents/Guide Sections (continued)

– 4-0: System Programs/Exam Procedures• 4-1 Software Installation• 4-2 Patient Information• 4-3 Cuff Location and Placement• 4-4 Cuff Removal• 4-5 Triple Test: VOP, DVP and EVP Test Overviews• 4-6 Triple Test: VOP Test Steps• 4-7 Triple Test: DVP Test Steps• 4-8 Triple Test: EVP Test Steps• 4-9 Triple Test: Start Refill and Refill Volume Lines (on curves)• 4-10 Triple Test: Repeat Tests• 4-11 Exam Reporting• 4-12 Test Acceptance Criteria

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• Table of Contents/Guide Sections (continued)

– 5-0: Maintenance/Cleaning/Troubleshooting• 5-1 Maintenance• 5-2 Cleaning and Disinfection• 5-3 Troubleshooting

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• 1-0: General Information

– 1.1 Introduction

• Prior to operating this product, read and understand this User Guide along with any additional instructions provided

by the manufacturer. Review and follow all Danger, Warning and Caution Notices to avoid injury to operator and

occupant and damage to the product.

• Keep this User Guide and instructions with this product for future reference. Operators need to become familiar with

this product before using. Safety is the most important element of any procedure. Knowledge and safe working

habits are essential to preventing death, personal injury, or property damage. Use the following statements as a

common-sense guide to proper work and equipment use habits.

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• 1-0: General Information

– 1.2 Preparing to Use This Product

• This User Guide is for the ACS Ven-View Examination Module as a stand-alone device. Parts of this User Guide also

discuss the use of the Ven-View Examination Module with the ACS Positioning Chair. Combined, these two devices

make up the ACS Ven-View Vascular System. If using the ACS Positioning Chair separately, or with the Ven-View

Examination Module, it is strongly recommended that the user read the ACS Positioning Chair User Guide (separate

from this document).

• Preparation is essential to complete a procedure in a safe and efficient manner.

• Always use proper personal protection equipment to prevent potential hazards.

• Follow all procedures in this User Guide. Never take shortcuts.

• Be prepared for emergencies. Accidents can happen, even under the best conditions and with the best preparation.

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• 1.3 General Safety Notices

– Throughout this User Guide, the following key safety notices will be used to alert the reader of potential hazards. Become familiar with

these notices and their meaning. Take all precautions to avoid the hazards described.

This safety alert symbol is used to alert you to potential hazards

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• 1-4 User Safety

– Avoid a potentially hazardous situation. Always follow procedures and safety warnings.

– Never leave a patient with the Ven-View Examination Module unattended. The system uses pressure cuffs which should not

be applied to the patient and left unattended.

– Reduce the risk of Bloodborne Pathogens: always clean and disinfect the chair properly. Failure to clean and disinfect properly may result in injury to patients and/or operators.

– Always follow cleaning and disinfection instructions as explained in this User Guide for cleaning the Ven-View Examination Module.

– WARNING: If incorrectly used this product may cause injury. Those who use and maintain it should be trained in its proper use, warned of its dangers and should read the entire manual before attempting to set up, operate or adjust this product.

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• 1-4 User Safety (continued)

– Any misuse of the Ven-View Examination Module may result in injury and damage to the product, and will void any warranty.

– The product should be operated only from the type of power source indicated in this Users Guide.

– Do not use this product near water or a heat source such as a radiator.

– Openings in the computer (if provided) and in the back electrical box are provided for ventilation. Do not block or cover these openings.

– This product is equipped with a three-wire power cord to make sure that the product is properly grounded when in use. The plug on this cord will fit only into a grounding-type outlet. This is a safety feature.

– Do not use an extension cord with this product. Plug the supplied power cord directly into a three-wire wall outlet.

– Do not walk on the power cord or allow anything to rest on it.

– When the system is turned off, a small amount of electrical current still flows through the system. To avoid electrical shock, always unplug all power cables from the wall outlets before cleaning the system.

– Class I, type B equipment. Not suitable for use with flammable anesthetics, continuous operation and/or ordinary equipment.

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• 1-5 Operator Requirements

– Safety is the most important element of any procedure. Knowledge and safe work habits are essential to preventing death, personal injury or property damage .

– Only properly trained personnel should be permitted to operate this product.

– A skilled operator should have a complete understanding on the following patient handling procedures:

• Placing pressure cuffs correctly on patient as instructed in this manual

• Familiarity with automated, electrical medical equipment

• Patient assessment

• Basic software understanding based on instructions in this manual

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• 1-6 Mechanical, Electrical and Safety Certifications

– The Ven-View Examination Module complies with test for Electrical Safety in accordance with IEC 60601-1.

– The Ven-View Examination Module complies with testing for EMC Emissions and Immunity in accordance with IEC 60601-1-2:2007 and is rated Class A for EMC (commercial/clinical environments, not residential use):

– Radiated emissions– Conducted emissions – Flicker – Harmonics– ESD– Radiated immunity– EFT– Surge– Conducted immunity– Magnetic field immunity– Voltage drops

– Voltage interruptions

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• RoHS Compliance

• All parts and components used in the design of the Ven-View Examination Module meet RoHS Directive 2002/95/EC unless

otherwise stated by the manufacturer.

• IPX (Water Ingress) Rating

• The Positioning Chair is considered to have an IPX2 rating in accordance with ANSI/IEC 60529:2004 Degrees of Protection Provided

By Enclosure (IP Codes) and should never be subjected to water jet hose spraying or aggressive spraying of any kind to clean. This

rating is applicable to the enclosure, but not occlusion and sensing pressure cuffs or accessories used with the product and not

authorized by the manufacturer.

– 1.7 Warranty

• Advanze Cardo Systems (ACS) warrants to the original purchaser that its products should be free from manufacturing non-

conformances that affect product performance and customer satisfaction for periods as defined for the Ven-View Examination

Module:

– 6 months from purchase: parts and labor covered– 3 years from purchase: parts covered (only)

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• Advanze Cardio Systems’ obligation under this warranty is expressly limited to supplying replacement parts and labor for, or

replacing, at its own option, any product that is, in the sole discretion of Advanze Cardio Systems, found to be defective. Any

improper use or alteration or repair by unauthorized service providers in such a manner as is Advanze Cardio Systems’ judgment

affects the product materially and adversely, shall void this warranty. Any repair of Advanze Cardio Systems’ products using parts not

provided or authorized by Advanze Cardio Systems shall void this warranty. No employee or representative of Advanze Cardio

Systems is authorized to change this warranty in any way without the approval of the Company President. This statement constitutes

Advanze Cardio Systems’ entire warranty with respect to the aforesaid product and associated parts and components.

• ADVANCE CARDIO SYSTEMS MAKES NO OTHER WARRANTY OR REPRESENTATION, EITHER EXPRESSED OR IMPLIED, EXCEPT AS SET

FORTH HERIN. THERE IS NO WARRANTY OF MERCHANTABILITY AND THERE ARE NO WARRANTIES OF FITNESS FOR ANY PARTICULAR

PURPOSE. IN NO EVENT SHALL ADVANZE CARDIO SYSTEMS BE LIABLE HEREUNDER FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES

ARISING FROM OR IN ANY MANNER RELATED TO SALES OR USE OF ANY SUCH EQUIPMENT OR PRODUCT.

– 1.8 Return Policy

• Product cannot be returned without an authorization number provided by ACS’ Customer Service department. Please

call 1-507-932-5028.

• Unused and undamaged product, along with accessories, may be returned up to 30 days of shipment. Custom or

modified product is not subject to return. All product must be returned in the original packaging for the return policy to

be effective and receive an RMA number before shipment back to the Company.

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Ven-View Examination Module Users Guide• Damaged Product

• Claims for damaged product must be made within 5 days of receipt. Short shipment claims must be made within 15 days of receipt. Notification to ACS under ICC Regulations outlined above result in a freight bill claim issued to the appropriate carrier for damage incurred, not to exceed actual replacement cost. In the event ACS is not within the guideline above, the customer will be responsible for the original invoice in full.

• 2-0: Description and Features

– 2.1 Product Description

• The venous system of the lower limb consists of deep and superficial veins. The muscles, which are enclosed in a firm connective tissue membrane (fascia) separating them, surround the deep veins from the skin and subcutaneous tissue. The superficial veins lie outside the fascia under the skin. The two systems communicate through a number of so-called perforating (communicating) veins, which perforate the fascia and the muscle bundles and connect deep and superficial veins.

• The lower limb veins possess valves which prevent the backward flow of the blood. The valves direct the blood from distal to proximal and from superficial to deep veins.

• At rest, blood outflow from the lower limb depends on the hydraulic pressure generated by cardiac contraction and the elasticity of arterial walls. Since the pre-capillary resistance vessels lie upstream, the hydraulic pressure of blood as it enters the venous system is usually low. Furthermore, in a vertical position blood outflow is reduced because of hydrostatic pressure resulting from gravitational effect of the blood column extending to the level of the right atrium. In a horizontal position hydrostatic pressure is low or absent.

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• 2-0: Description and Features


• During physical activity (e.g. walking) blood outflow from the lower limb is enhanced by the rhythmic contractions of the calf muscles, which compress the deep veins, and propel the blood upwards in the direction of the heart. During muscle relaxation valves close preventing the backflow of blood. This muscular-venous pump increases blood flow in the calf by as much as 50 % over that possible from hydraulic pressures alone. It constitutes an important physiological mechanism that helps to maintain the homeostasis in the circulatory system.

• The circulatory homeostasis is manifested by the balance between arterial and venous pressure at the level of capillary vessels. Under normal conditions intra-capillary pressure resulting from this balance is optimal, allowing proper circulation of tissue fluid.

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Ven-View Examination Module Users Guide• 2-0: Description and Features (continued)


• Under pathological conditions the balance between arterial and venous pressure may be disturbed, which may lead to the increase of the intra-capillary pressure and the retention of the fluid in the tissues (edema), followed by nutritional dysfunction. This occurs when the function of the venous system of the lower limb is affected by any obstruction, which prevents free passage of blood through the veins (e.g. thrombosis), or by incompetent valves which allow the backflow of blood.

• The Ven-View™ Vascular Assessment System (consisting of the Ven-View Examination Module and Positioning Chair) is a reliable and cost effective diagnostic method for exclusion or confirmation of both venous obstruction and venous insufficiency.

• An optional examination chair (Positioning Chair) provides a simple ergonomic solution for positioning and moving the patient to achieve noiseless examinations while keeping the patient feeling comfortable and stable.

• The ACS Ven-View Examination Module is designed with both patient and operator in mind. The Module is used for evaluating peripheral vascular blood flow and includes three main measurements: Outflow Plethysmography (lower extremity venous obstruction), Passive Draining and Refilling (lower extremity valve incompetence) and Exercise Venous Plethysmography (lower extremity calf muscle pump function).

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Ven-View Examination Module Users Guide• 2-0: Description and Features (continued)


• The Module is a simple “box” which uses air valves and pumps and sensing mechanisms (transducers) to inflate and deflate air pressure cuffs on the thighs (occluding) and on the calves (sensing) in order to measure dynamic changes in the lower extremities.

• The Module may be used with the ACS Positioning Chair (called the Ven-View Vascular System), or as a stand-alone module with the patient being manually positioned for testing. The ACS Positioning Chair has been specifically designed to support 400 lbs. of patient weight and contains both the movements and speeds needed for conducting accurate venous studies.

• If the Ven-View Examination Module is NOT used with the ACS Positioning Chair component, ACS cannot be responsible for injury to the patient or healthcare provider caused by moving the patient for testing.

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– 2.2 Ven-View Examination Module Features

• The Ven-View Examination Module consists of these major components:

– The Examination Module: Electrical and mechanical components provide for the “brains” of the examination. The Box determines when cuffs apply and release pressure and general logistics of the venous evaluation.

– Thigh and Calf Air Pressure Cuffs: Air pressure cuffs provide for occlusion and blood flow release in lower extremities during venous evaluations. Air pressure cuffs around the calf provide more exact detection of limb changes as compared to more common strain gauge plethysmography.

– Easy-to-Use, Interactive SoftwareThe Ven-View Examination Module software is not complicated to use and provides easy-to-read indices and test values. All data is easily printed for reimbursement needs.

• While the Ven-View Examination Module is simple to use, the product contains many valuable features for the user.

– Small Compact Size: The Module is designed to be placed on a desk or table. When used with the ACS Positioning Chair, the Module fits securely on either side of the Chair underneath the seat cushion as shown:

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– 2.2 Ven-View Examination Module Features (continued)

– Small Compact Size: The Module is designed to be placed on a desk or table. When used with the ACS Positioning Chair, the Module fits securely on either side of the Chair underneath the seat cushion as shown:

– Easy Set-Up: The Module is simple to set-up for conducting a venous exam. Occlusion cuffs are marked with a black colored identifier. Occlusion cuffs are inserted into the black female ports of the Module while the right sensing cuff is used for the right leg, the red for the left. Each sensing cuff is plugged into the color-coordinated female port. Power on the Module and plug the USB cable to the Module (if using the ACS Positioning Chair) and the system is ready!

– Simple User Interface: The Ven-View Examination Module interfaces with a simple-to-use software package. This software package prompts the technician/healthcare worker through all venous programs, making accurate data consistent and reliable. Audible sounds reinforce software functionality so that important test transitions are not missed.

– Ergonomically Sound: When used with the ACS Positioning Chair (as the Ven-View Vascular System) the Module provides hands-free assessment capability. All Positioning Chair movement is controlled by a simple foot control, leaving the users’ hands free to follow the software’s prompting. Once occlusion and sensing cuffs are applied, the technician/healthcare worker simply starts the software and allows the Module to run automatically. Audible and visual prompts notify the technician/healthcare worker when chair movement (sitting or supine) is required- no lifting or shifting patient weight manually is necessary.

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• 3.0: Specifications

– 3.1 Chair Specifications, Dimensions, Capacity, Safety and Power

• Class I, Type B Equipment. Not suitable for use with flammable anesthetics, continuous operation and/or ordinary equipment.

• Only personnel familar with servicing electrical medical devices should service this product.

• Grounding Reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “hospital only” or “hospital

grade.”

• Power Supply Input Rating: 100-240V, 50-60Hz, 2A

• Power Supply Output Rating: 15V, 150W

• The ACS Ven-View Examination Module has the following specifications:

– Length: 11.00 inches

– Width: 6.00 inches

– Height: 8.00 inches

– Weight (approx): 13 lbs.

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• 3.0: Specifications

– 3.1 Chair Specifications, Dimensions, Capacity, Safety and Power

• The minimum requirements for a laptop/desktop used with the Ven-View Examination Module are the following (if not purchased with the System):

• Intel Processor with 1.6 GHz speed• 1 GB RAM• 800 x 600 Screen Resolution• 40 GB Hard Drive • Ethernet Network Port• USB Port (for communication cable from Module to laptop/desktop• Microsoft Windows XP or 7

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• 4-0: System Programs/Exam Procedures

– 4-1 Set-Up/Software Installation

• The Ven-View Examination Module contains the following components: the examination Module (box), sensing and occluding cuff assemblies, power cord and flash drive (USB) containing pre-loaded Ven-View software and a tape measure.

• An optional laptop computer, power cord and 12V adaptor are available from ACS and may be included with other contents mentioned above.

• Before using the Module, the Ven-View software must first be installed on your laptop (unless the laptop arrived pre-loaded from ACS with purchase).

• Use the provided flash drive and insert into your computer’s USB port. Following the prompts for installation and remove the flash drive from your computer when complete.

• With the software installed, power the Module by inserting one end of the power cord/brick into the back of the Module and the other into mains.

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• 4-0: System Programs/Exam Procedures (continued)


• Next, plug the occluding cuffs into either black colored port. Both ports are the same and allow for either occluding cuff fitting.

• Sensing cuffs are color-coded as shown below and must be inserted into the proper port on the display front of the Module:

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• Only the power supply and occluding/sensing cuffs provided with the Ven-View Examination Module may be used! No other replacements should be used with the System unless provided by ACS.

• When power is supplied to the Module and all pressure cuffs are attached, attach one end of the provided USB cord to the Module front as shown below. Insert the other end of the USB into an available port on the computer. Power on the Module by selecting the ON function on the display front.

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• The supplied 12V adaptor must be used to power the computer through the Module. Due to isolation issues, never plug the computer to mains and then use the USB to communicate between the computer and Module. The correct configuration, as shown below, has the computer powered by the Module through the 12V adaptor.

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ven-view examination module users guide part of the osborn medical/acs ven-view vascular system

Documents

triple test

user safety

commonsense guide

vop test steps

dvp test steps

evp test steps

general safety notices

evp test overviews