MD Tumescent Measuring Device User Manual
Contents
1. back to assure this is the case 2 Tubing doubled up and down not overly pinched and Velcro fastened to pole Assure tubing will not slip down pole by giving it a sample tug downward These two steps assure stable and accurate measurement of tumescent delivery2. Introduction This guide provides instruction for operation maintenance and troubleshooting procedures for the Tumescent Measuring Device the TMD All users should be versed in its use and application before actual use and application Warnings and Cautions All personnel should review and be familiar with the following warnings and cautions prior to using the TMD a Caution Do not immerse the TMD Immersion will cause permanent damage to the circuitry Do not use an excessive amount of liquid when cleaning Never allow liquids to enter the TMD case Caution A specified power supply must be used Power may be taken from a MD Resource tumescent delivery pump that has an auxiliary DC direct current outlet or from separate medical grade power supply with a standard barrel connector 5 5 x 2 1 x 9 9 mm straight female positive center with an output voltage of 8 VDC to 32 VDC at 100mA Caution When loading TMD use gentle motion Never roughly pull on hook Caution Maximum load on hook should never exceed 4 000ml Caution The TMD weighs enough that its falling off the IV Pole due to incomplete or otherwise faulty mounting could do serious bodily damage Take care in its set up making sure that the mounting is complete and correct Caution The TMD is designed to be mounted on a 7 8 diameter pole that is mounted vertically Accuracy of measurement is compromised with any non rigid mounting Other mounting options a
3. ained used or adjusted otherwise than in accordance with instructions provided by Medical Device Resource Corporation in these Instructions For Use 24 M D RESOURCE E E medical device resource corporation TMD Tumescent Measuring Device Instructions For Use Rev 2 0 15 MAY 2012 Medical Device Resource Corporation 5981 Graham Court Livermore CA 94550 www MDResource com Mel MDResource com Toll free 1 800 633 8423 Direct 510 732 9950 Fax 510 785 8182 User Maintenance 1 The TMD is factory calibrated if calibration becomes necessary return for service 2 The hospital grade power adapter is included with the TMD includes a detachable AC power cord This should be inspected periodically for damage and should be replaced when worn If the DC connector or its cable becomes damaged the power adapter should be replaced 3 Ifthe nylon pole mounting screw or the start switch button get misplaced they are available from the factory Cleaning TMD 1 Ammoniated Cleaners may be used to gently clean the TMD case 2 Use only a soft cotton cloth to gently clean the digital display face 3 DO NOT IMMERSE TMD DO NOT USE AN EXCESSIVE AMOUNT OF LIQUID WHEN CLEANING NEVER ALLOW FLUIDS TO ENTER TMD CASE General Description The TMD is a digital scale based on load cell technology with associated circuitry and display mounted with a load bearing steel foundation and assembled in an ABS package It is desig
4. e above limitations may not apply Technical Specifications for TMD a Power input 8 to 32 VDC 100mA maximum Typical usage is 8 to 32 VDC 30mA while on and 8 to 32 VDC 10mA while off a Display 5 digits 0 to 6000g backlit with blue panel light a Accuracy lt 1 error 1 gram given reasonably level TMD mounting level 7 degrees a NOTE ON ACCURACY TMD accuracy reflects the loss of weight in the suspended tumescent bag s All tumescent displaced from the suspended mass will be measured There is no way it can know the amount of tumescent not delivered to the patient Technical Manuals Repairs are only authorized by the manufacturer or a factory approved repair facility Technical service manuals are not available to users for this reason Concealed Shipping Damage Please set up and operate the product as soon as possible to discover any hidden shipping damage If damage is revealed contact the carrier to have an agent inspect the damage Most freight and shipping companies have a limited time period for accepting this type of loss or claim Contact your carrier immediately The carrier reserves the right to refuse any loss or concealed damage claim made beyond that time Medical Device Resource Corporation is not responsible for the collection of claims or replacement of damaged merchandise We will aid you in any way possible to achieve a satisfactory outcome for your damage claim Fil
5. e s to secure this these tubes so that the weight of the tubing further down and the inevitable movement of these tubes do not bear on the TMD See Diagram 1 The TMD hook must not rub on the hole through which it is positioned It is important that the Velcro ties are used as the infiltration device and changing weight of the tubing as tumescent is being displaced will otherwise make for an erratic delivery display As tumescent is withdrawn from the bags the display will show an increasingly negative number This is the amount of liquid delivered in CCs The display takes a moment 1 to 3 seconds to stabilize after delivery is temporarily halted or completed Note This section does not include the particulars for the setup and usage of the infiltration pump that will be used in conjunction with the TMD These instructions are specific to the device being used and should be followed as per its manufacturer s instruction a Conditions of Limited Warranty All claims for defective products must be made in writing within the warranty period and any claims not made within that period shall be deemed waived and released Medical Device Resource Corporation may at its discretion replace a product in whole or in part with comparable equipment and may use re manufactured and reconditioned parts in performing service Transportation charges on parts submitted for repair or replacement under this Limited Warranty must be borne by registered us
6. er Medical Device Resource Corporation shall have no liability for delay or failure to provide service to a product due to war civil commotion acts of public enemies acts of terrorism blockade embargo strikes acts of God inability to secure raw materials transportation facilities fuel or energy shortages acts or omissions of communications carriers or any other act whatsoever whether similar or dissimilar to those referenced above which is beyond Medical Device Resource Corporation s reasonable control This Limited Warranty is for a commercial non consumer product and is valid only in the United States The Limited Warranty shall be governed by the laws of The Commonwealth of Massachusetts without regard to its conflict of laws and provisions This Limited Warranty applies only to the original registered user and is not transferable to a third party without Medical Device Resource Corporation s prior written consent This Limited Warranty constitutes the entire agreement between parties and shall not be amended except by written agreement If any provision of this Limited Warranty is found invalid or unenforceable the remaining provisions shall remain in effect This Limited Warranty gives the registered user specific legal rights The registered user may also have other rights which vary depending upon local laws In some areas local laws do not apply limitations on warranties remedies or liabilities therefore some of th
7. ing and handling the claim is your responsibility Return Procedure Contact Medical Device Resource Corporation before returning any merchandise Have the following information available at that time Invoice or relevant information to invoice a Contact person and phone number a Serial number a Reason for return If the product has been exposed to any bio hazardous material or used in surgery or surgical related area it must be cleaned and sterilized and have a written statement of confirmation of sterility accompanying the returned product Limited Warranty Medical Device Resource Corporation products are manufactured for use by qualified medical personnel trained and skilled as medical professionals a Scope of Limited Warranty The TMD Pump is warranted to be free from manufacturing defects in materials and workmanship for a period of one year from date of purchase The Limited Warranty shall apply between Medical Device Resource Corporation and the registered user of the TMD Pump a Exclusions This Limited Warranty does not cover routine maintenance or expendable parts a Circumstances rendering Limited Warranty Invalid This Limited Warranty will become invalid in respect of any product if 1 the product has been damaged in any way other than by Medical Device Resource Corporation by misuse mishandling improper operation abuse of the product or otherwise 2 The product has been installed stored maint
8. n will repair or replace free of charge any parts that are defective in material or workmanship during the time period of the Limited Warranty Medical Device Resource Corporation s obligations under this Limited Warranty are limited to repair or replacement of the part or parts found to be defective and such repair or replacement shall be a registered user s sole and exclusive remedy a Disclaimers and Limitations of Liability Medical Device Resource Corporation s obligations under this Limited Warranty shall under no circumstances exceed the cost of the product or part for which the claim under this Limited Warranty is made This Limited Warranty contains all the warranties which Medical Device Resource Corporation gives in respect of the TMD Pump and related parts and Medical Device Resource Corporation expressly disclaims all other warranties either express or implied including without limitation any implied warranties of merchantability or fitness for particular purpose In no event shall Medical Device Resource Corporation be liable for consequential indirect special or incidental damages including without limitation damages for loss of profits loss of use or any other indirect damages of any kind but Medical Device Resource Corporation does not exclude its liability for death or personal injury caused by its negligence Diagram 1 1 Hook must not touch enclosure exit hole It may be swung left and right forward and
9. ned and configured to measure to 4 000 grams corresponding to the usage of 1 to 4 000 ml of tumescent The configuration is such that as tumescent is delivered to the cannula via tumescent delivery pump the digital display shows the amount of tumescent displaced Description of Device Front Panel 1 5 digit LCD display with blue backlighting It is visible with a 60 degree viewing window for up to 10 ft 2 Start switch Push once for on and once for off Rear Panel 1 Power plug that accepts a standard barrel jack 5 5 x 2 1 x 11 mm straight female positive center Power in may be from 8 to 32 VDC at 100 mA positive center 2 Nylon pole mount screw for fixing the TMD s position on its pole Bottom 1 Hook for hanging tumescent bags up to 3 liters of tumescent It is free hanging and may be rotated 360 degrees 2 Pole insertion cylinder mount TMD to pole here This cylinder will accept a 7 8 0 875 OD pole An adapter for Y standard IV Poles is available Inside 1 Load cell and associated circuitry 2 Tool foundation for load cell monitoring Patent Pending 3 The product has been repaired serviced replaced worked on or altered by any person not authorized by Medical Device Resource Corporation 4 The product has been used for a purpose which is not intended for it 5 The serial number on the product has been altered or defaced a Sole Remedy Medical Device Resource Corporatio
10. re available consult Medical Device Resource Corp Modification Changes made to the TMD or it s advised procedural usage may adversely affect its performance or accuracy Any requests for changes in its design or use should first be communicated with the proper Medical Device Resource Corporation MDRC personnel Setup Instructions l Extend pole no larger than 7 8 diameter to desired height Make sure nylon pole mount tightener is loosened that TMD may be slid fully over pole Place TMD so pole inserts fully into the mounting cylinder This is slightly more than 2 of insertion Total insertion is important for operator safety device accuracy and potential device damage abatement After putting TMD in the desired viewing position fix this location with the nylon pole mount screw Not tightening this set screw may lead to poor viewing and or scale inaccuracy Not using the set screw may lead to device damage or operator injury Connect power plug from the universal AC adapter to the power inlet on the rear panel Alternatively the DC power may be supplied with an umbilical connected from the auxiliary DC outlet on a Medical Device Resource K pump DC power into the TMD may be from 8 to 32 VDC at 100 mA Diagram I shows a power umbilical route with the supplied Velcro ties Place the needed tumescent bag s on the hook connect the tubing that will connect this these to the infiltration pump Use included Velcro ti
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