TM-FLOW SYSTEM

LD-OXI CONTRAINDICATIONS When using the oximeter probe, use the finger of the arm not in use with the blood pressure cuff,arterial catheter, or having an AV fistula or pressure dressing. Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine,and fluorescein. Signifcant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, willaffect the accuracy of the SpO2 measurement. Any condition that restricts blood flow, such as the use of a blood pressure cuff or extremes insystemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2readings. For elderly patients or subjects with a weak pulse due to shock, low ambient/body temperature,major bleeding, or use of a vascular contracting drug, the SpO2 waveform will be decreased orabsent. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. Venous pulsations may cause erroneous readings in blood pressure (e.g. tricuspid valve regurgitation). Be careful with low perfused patients. Using the blood pressure device may cause skin erosion and/or pressure necrosis. Valsalva maneuver should not be performed on persons:- Undergoing procedures with proliferative retinopathy.- Systolic Blood pressure of 160mmHg or higher.- Anyone who’s had laser treatment for retinopathy within the past three months.WARNINGS Galvanic skin response and habituation: There is a decrease of GSR amplitude observed aftermultiple electrical stimulations. It is not recommended to repeat the test before 20 minutes. The PC, and/or other devices used and connected to the PC, should be in compliance with StandardsIEC950 and/ or UL1950. The labeling EC or UL in a computer will indicate the compliance to thesestandards.The use of a computer not in compliance with its standards could damage the hardware and provokea breakdown. In case of a breakdown never open the hardware and/or try to repair it. LD TECHNOLOGY does not guarantee the safety and effectiveness of the device in the event ofuse with other accessories. The SweatC, TM-ABI and TM-Oxy hardware are not sterile: Do not autoclave; do not use ethyleneoxide sterilization, or immersing the device and the accessories in liquid. The carrying case foam liner cannot be disinfected. Using a damaged patient cable may cause inaccurate readings, which could possibly result in injuryor death. Inspect the patient cable. If the patient cable appears damaged, do not use it and Contactthe manufacturer. An incorrectly applied blood pressure cuff placement may give inaccurate readings. Do not use this device in the presence of flammable anaesthetics. Spark hazards exist which maycause an explosion. Review the blood pressure cuff placement instructions below for proper application.12

The device cannot be stored in the carrying case. It should be stored in a clean, dry and disinfectedarea before use on any patient. Before shipping the hardware back to the manufacturer for repairs or calibration, the user mustdisconnect the cables and electrodes, and disinfect the device and accessories prior to placing themin the return case. This device is intended for use by persons trained in professional health care. The operator must bethoroughly familiar with the information in this manual before using the device.If the systolic pressure is 30 or 255 mmHg or diastolic pressure 15 or 220 mmHg, the softwarewill display an error message and will stop the measurement.Any blood pressure recording can be affected by the position of the subject, his or her physiologiccondition, and other factors such as: Taking the blood pressure measurement:- Less than 1 hour after meals- After exercise or sporting activity- After drinking alcohol or coffee- After bathing- Less than 1 hour after smoking White-Coat Hypertension (anxiety) Factors during Readings: Something as simple as moving the arm while blood pressure is beingtaken can affect the reading. If the sleeves of a shirt fit too tightly over the cuff, or if the cuff size iswrong, the readings could be inaccurate. Features: When the blood pressure reading is being taken, patient should be lying in a comfortableposition. Considerations: Other factors include age, race, temperature, medication, emotional state, stress,exercise, smoking, and medical conditions such as diabetes, obesity, cardiovascular disease, irregularheartbeat, pregnancy and alcoholism. These factors need to be taken into account to determine anaccurate measurement of blood pressure.- The accuracy of the blood pressure device should be verified, and we recommend that acalibration is performed annually.- The blood pressure device might not meet its performance specifications if stored or usedoutside of the temperature and humidity range.- Blood pressure measurements determined with this device are equivalent to those obtainedby an intra-arterial blood pressure measurement device within the limits prescribed by theAmerican National Standard for manual, electronic, or automated sphygmomanometers.- Cardiac arrhythmia may cause an irregular heartbeat, and may increase the measurement time.- If the patient is on a Heart-Lung machine, the measurement may not be possible.- Rapid pressure changes may not be possible to record.- Severe shock or hypothermia may give unreliable results since reduced blood flow to theperipheries will reduce pulsation of arteries.13

INSTALLING THE SETUP PROGRAMLD Technology provides a CD or USB flash key Click on TM-Flow Setup and then follow thewith a setup program. When you open the CD or indications. The software and drivers will beUSB flash key you will have the following file:automatically installed at the end of the process.SOFTWARE ACTIVATION & REGISTRATIONFIRST TIME SOFTWARE ACTIVATIONAt the end of the setup window opens with thesoftware code number. Click onin order to get your activation Pin code afterregistration.REGISTERING YOUR SOFTWAREYour computer must be connected to internet.The window open and you have to fill all therequired information.The email and the password your created willallow you to receive the patient reports thoughtthe secure cloud.Click onand you will receiveyour Pin code activation in your email box.Enter the Pin code activation in the boxand then click onyour TM-FLOW software.14toaccessto

PRESENTATION OF THE SOFTWARESOFTWARE INTERFACEStarting and becoming familiarized with the TM-FLOW Software.Click on the TM-Flow icon on your desktop to access the software. This will bring up the TM-FLOWhome screen.Here you can log into your patient database, create a new patient database, create a password, viewyour contract, view your license agrement, consult the eManual, and contact the online technicalsupport.15

HOME SCREENTHE TOOL PANELOn the left side is the tool panel. The panel contains different tools available to the user on everyscreen. While on the home screen, the three tools you can access are:EMANUAL :Click on this icon to open the TM-FLOW instruction for use.SUPPORT :Provides access to online technical support during your TM- FLOW experience.LICENSE AGREMENT BUTTON :Click on the icon to view your current contract with LD Technology.LOGIN TO DATABASEThe Database Login on the main panel of the home screen contains seven fields and buttons:FORGOT YOUR PASSWORD BUTTON:If you ever forget the password to one of your databases, thisbutton will allow you to contact technical support and retrieveyour password. CREATE NEW DATABASE BUTTON:If you would like to create a new database, click on this buttonto enter a database name and optional password.THE DATABASE LOGIN:In the database field, select the patient database you wouldlike to open from the dropdown box.PASSWORD:Proctect your database with a password.16

NAVIGATION SCREEN161552146387911Results and patient report buttons can be usedonly if a patient name and visit have beenselected, otherwise the following error messagewill appear: “Please select a patient and visit.”101213141. ADD A NEW PATIENT2. IMPORT A PATIENT (FROM A FILE)3. PATIENT DATABASE4. DATABASE MANAGEMENT5. PATIENT PROFILE6. PATIENT MANAGEMENT7. PATIENT VISIT8. PATIENT VISIT MANAGEMENT9. VIEW RESULTS10. START A NEW MEASUREMENT11. E-MANUAL12. SETTINGS13. SUPPORT14. EXAM COUNT15. SIGN OUT (CLOSING THE SOFWARE)16. HOME (RETURNING TO THE LOGIN PAGE)17

THE TOOL PANELThe Tool Panel now has four new buttons in addition to the ones we previously introduced.These five buttons are as follows:HOME BUTTON :Log you out of the current database and returns you to the home screen.SIGN OUT BUTTON :Log you out to windows.SETTINGS :Clicking on this button will take you to the Settings Dashboard.Please see the Settings Dashboard instructions for further details.EXPORT DATA TO EXCEL :On the Settings Dashboard you can export Patient Measurement information to Excel,which can be done by clicking on the Measurements Performed checkbox and pressingthe button. All patient name and measurements date will be exported to Excel.THE DATABASE PANELThe Database panel contains all of your patients stored in the current database. Each selected patient’sinformation and associated visit(s) will appear on the right. Double clicking on the name of the patient will give you access to the test result of the patient.Also, click on View Result button does the same.18

THE PATIENT MANAGEMENT PANELEDIT PATIENT BUTTON:The Edit Patient button will allow you to change general patient information.This will open the Patient Data form where you can input changes.DELETE PATIENT BUTTON:The Delete Patient button will allow you to delete a patient from your database,and will bring up the following prompt:THE DATABASE MANAGEMENT PANELDISPLAY NAMEA-Z ORDERLAST VISITHIPAADISPLAY NAME BUTTON:Displays the patient name.A-Z ORDER BUTTON:Clicking on the Sort A-Z button will sort your patient database list in alphabeticalorder.LAST VISIT BUTTON:Clicking on the Last Visit button will sort your patient database by organizingthe patients with the most recent visit at the top of the patient database list.HIPAA BUTTON:Clicking on the HIPAA button will encrypt your patient database list to complywith HIPAA regulations.19

THE VISIT MANAGEMENT TOOLBOXVIEW PATIENT REPORT BUTTON:The view patient report will open the status report of thepatient corresponding to the selected visit.EDIT VISIT BUTTON:The Edit Visit button will edit the currently selected visit. Pleaserefer to adding a visit instructions for further information onhow the visit information should be entered.DELETE VISIT BUTTON:The Delete Visit button will delete the currently selectedpatient visit. However, if only one patient visit exists, this buttonis inactive. You will have to click on Delete Patient in order toclear the patient visit and re- enter patient information on thePatient Data form.ADD PHYSICIAN NOTES BUTTON:The physician notes form allows you to create notes for thecurrent patient. The notes and optional uploaded signaturewil be reported in the patient report.Clicking the «OK» button will save thenotes.Clicking the «Cancel» button will disposeof any note added.20

PATIENT REGISTRATIONADD A NEW PATIENT MENUTo add a new patient to your database, completethe patient information. Once clicked on the savebutton, it will direct you to the visit form.IMPORT A PATIENT BUTTON:To add a new patient from another database, clickon the icon, a window opens, select the patientname and then click on «Ok».None of the other fields on this form aremandatory, but may be helpful in patient recordkeeping.By clicking on thebutton, you will betaken to the Visit form for further patient medicalexamination information. Please see adding avisit instructions for further details.You will be prompted to enter the patientdemographic information. If not entered, or enteredincorrectly, you will receive the following errormessages :This error message will appear if you have notentered the first and last name of the patient ORif you have entered a first name, but not a lastname or vice versa.This error message will appear if the date of birthentered is not a possible date of birth (within thesame year of current date).18This error message will appear if the age of thepatient is not compatible with the indications ofuse.21

SETTINGSSETTINGS:Click on the Settings Button to open the Setting options.TESTING FOR DEVICE FUNCTIONALITYOn the Settings Dashboard you can ensure thepulse oximeter, galvanic skin response device arefunctioning correctly.To test the pulse oximeter, make sure the OXIcheckbox is selected.Pressto proceed. The pulse waveformshould appear on your screen in the PulseOximeter Wave testing box.22To test the galvanic skin response device, makesure the GSR checkbox is selected.Pressto proceed.The galvanic skin response data should appear onyour screen in the GSR Testing box.

OXIMETER AND BLOOD PRESSURE DEVICE CALIBRATIONThe performance should be checked each year by the distributors of the manufacturer.Simulators are required for oximeter calibrationThe calibration Services are included in themaintenance contract or invoiced if the productdoes not have an active and/or valid warranty ormaintenance contract.The simulators are not provided with theequipment.For access to calibration, please contactthe your local distributor.CHANGING THE DEFAULT UNITSOn the Settings Dashboard you can changethe default units used throughout the softwareinterfaces between imperial and metric units bychecking the corresponding box in the settingsby default panel as follows:Choosing the A-Z selection will organize thepatient database list in alphabetical order.Choosing the Last exam selection will organizethe patient database list by order of patients withthe most recent examination dates.CHANGING THE DEFAULT DATABASE LISTORGANIZATIONYou can change the default appearance of thepatient database list by switching between codeand name as seen in the following panel.Choosing the code selection will ensurecompliance with HIPAA regulations by encodingpatient name. Choosing the name selection willdisplay the patient database items by first andlast name.Additionally, you can change the defaultorganization of the patient database list byswitching between the A-Z or Last exam selectionin the following panel.23

CHANGING THE DEFAULT STATUS REPORT CONFIGURATION AND SETTINGSOn the Settings Dashboard, you can change thestatus report settings.The Status Report Management form allows youto change the configuration of printed statusreports. You can add the Physician’s Name, Address,phone number, Fax, and E- mail in thecorresponding fields You can select the type of status reports you wouldlike to print :- Patient report included the Wellnesssuggetions- Physician report- TrendsNetworks Options- Server or EMR NetworkSelect «Use a Network». Check the boxand then click on «Network Credentials».This window will open. Fill the requesteddirectory for your server or EMR and thenclick on «Save».- Secure cloud accessIf you are not registered, select «Cloud isnot activated». This window will open. Clickon create an account and a secure serverpage will allow you to register in order toreceive the report in your tablet, computeror smartphone.24

CLEANING AND DISINFECTION METHODSTHE HARDWARE AND ACCESSORIES ARE NOT STERILEDo not autoclaveDo not use ethylene oxide sterilization or immersing the devices and the accessories in liquid.INSTRUCTIONS TO CARRY OUT PREVENTIVE MAINTENANCEAND MAINTENANCE FREQUENCYCLEANING / INFECTION CONTROL PROCEDURE.The oximeter probe, cuffs, manometer outputsand cables should undergo cleaning and low-leveldisinfection prior to their first use and betweeneach patient.Unplug the USB port connection before cleaningor disinfecting.The instructions for reprocessing the TM-Flowsystem reusable parts in contact with the intactskin of the patient : Oximeter probe Blood pressure cuffsReprocessing has been validated according tothe published method: Rutala, W.A., Weber D.J., & HICPAC. (2008). Guideline for Disinfectionand Sterilization in Healthcare Facilities, 2008.Atlanta, GA: Centers for Disease Control.)The system includes a reusable oximeter probeand a blood pressure cuffs which contact intactskin of the patient’s left arm and the right indexfinger, and per the Spaulding classification theyare “noncritical items “. Low-level disinfectantscould be used for noncritical items. The lowlevel disinfectants are listed in EnvironmentalProtection Agency (EPA): http://www.epa.gov/oximeters and cuff.Wipes with Ethyl or isopropyl alcohol (70-90%)could be used as well for the oximeter probes,blood pressure cuffs, electronic box, Cablestrunk of the cuff, computer, keyboard and mouse(surfaces environment).The carrying case and the foam liner cannotbe disinfected.Do not use Sodium hypochlorite (5.25-6.15%household bleach diluted 1:500).Do not use caustic or abrasive cleaning agents.The carrying case cannot be used forstorage of the device and accessoriesThe device and accessories should be storedin any clean area and need to be disinfectedprior to being used on the patient.We recommend after testing, the control ofresidues: Wipes with Ethyl or isopropyl alcohol(70-90%) for cleaning and disinfecting the reusable25

TAKING A MEASUREMENTPRECAUTIONSBe aware of Contraindications, Warnings, Cautions and Notes.1.The device, cables and cuffs must be cleaned/disinfected and then air dried. The proceduremust be performed before each patient.2. The exam area should be comfortable and free of drafts and portable electric heaters.The ambient temperature should be between 70-73 degree F ( 21-23 degree C)3.The measurement is carried out with the patient in a lying or reclined position, the feetshould be supported at the horizontal position.4. The right index finger must be free of Fingernail polish or false fingernails.5.Select the right size pressure cuff. The wrong size can cause erroneous readings. Use ofa cuff that is too large, too small, or improperly wrapped will result in inaccurate readings.Each patient’s extremity should be properly measured to determine the most appropriatecuff size. See below.6. The arm cuff will be placed on the left arm and oximeter on the right index finger. Donot place the arm cuff on the same side extremity with the oximeter during measurement.7. Do not place the pressure cuff in the same arm if a catheter or intravenous infusionis in place.8. Make sure that the air conductors are connected to the blood pressure cuffs, and thatthey are neither blocked nor tangled.9. Ensure that the pressure cuffs are completely deflated.10. To ensure a reliable reading follow these recommendations:- Avoid eating, drinking alcohol, smoking, exercising, and bathing 1 hour prior totaking a measurement. Rest for at least 15 minutes prior to taking the measurement.- Stress raises blood pressure. Avoid taking measurements during stressful times.- Measurements should be taken in a quiet place.- Remove tight-fitting clothing from the arm.- Rest arm and feet on the exam table or reclined chair.- Patient is to remain still and not talk during the measurement.26

OXIMETER PLACEMENT1. The oximeter shall be placed on the right index finger.2. Do not allow the patient to shake their index finger, and ensurethat patient is relaxed and in a stable state during the measurementprocess.3. The data can be read directly from the screen on the measuringinterface.CHOOSING THE RIGHT CUFF SIZESIt is extremely important to use the correct size of blood pressure cuff for the patient. Using an inappropriatecuff (which is the most common error in indirect BP measurement) can significantly distort BP readings.TM-ABI system is delivered with a Standard and Large adult cuffs. We can provide an Adult Thigh Cuffwith additional cost.Sizes of cuffs available, depending on the circumference of your arm:Adult ‘Standard’ or ‘Regular’ Cuff-fits most average-sized people. Large Adult Cuff-fits most plus-sizedpeople. Adult ‘Thigh’ Cuff-fits most supersized people or mid-sized people with heavy arms.HOW TO CHOOSE THE RIGHT CUFF SIZE:1.Arm and ankle circumference measurement prior to BP measurement: measure around the middleof the upper part of the arm and ankles, at the midpoint. (inches or centimeters).2.Use the

TM-ABI INTENTED USE The TM-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TM-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults.