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Copyright Datrend Systems Inc. (“DSI”) agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Datrend Systems Inc.
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Warranty and Product Support Datrend Systems Inc. ("DSI") warrants the Base and Simulation Modules of vPad-A1 (the "Datrend product") to be free from defects in materials and workmanship under normal use and service for one (1) year from the date of original purchase.
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Warranty Disclaimer Should you elect to have your instrument serviced and/or calibrated by someone other than Datrend Systems or an Authorized Service Centre, please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality Seal is removed or broken without proper factory authorization. We strongly recommend, therefore, that you send your instrument to Datrend Systems or an Authorized Service Centre for service and calibration, especially during the original warranty period.
OPERATORS MANUAL Abbreviations and Definitions The following abbreviations, terms and acronyms may be used throughout this manual: μA Micro-ampere Ampere AAMI American Association of Medical Instrumentation Software application for a mobile device Equipment Under Test. The electrical device being tested.
The following symbols may be found on vPad-A1: CONSULT MANUAL FOR PROPER OPERATION The operating manual provides valuable information on the proper use of vPad-A1. It is highly recommended the operator read the instructions thoroughly before operating the device. It may be possible to damage the Equipment Under Test (EUT) and/or cause harm to the operator if vPad-A1 is used incorrectly.
The base module includes hardware for charging an internal battery which provides power to the base, the pulse oximeter tester, and the ECG/IBP simulation module. The vPad-A1 software or "app" runs on the tablet computer and is used to operate the simulation/test modules.
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OPERATORS MANUAL Wired Connectivity........Micro USB 2.0 Type B XBUS Interface (RJ12-6) Wireless Connectivity........802.11 b/g/n Bluetooth 2.1+ EDR Memory, Internal..........8GB Storage (~6GB available) Modes of Operation........USB wired connection Bluetooth wireless Environment: • 15°C to 40°C (59°F to 104°F) •...
OPERATORS MANUAL 1.2 Multi-Parameter Patient Simulation Multi-parameter patient simulation is provided by the vPad-PS module of vPad-A1. ECG General: • Simulation Type: Full 12-Lead ECG with independent outputs for each signal lead, referenced to RL • Output Impedance: 500, 1000, 1500, and 2000 ohms to RL •...
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• Pressure Waveform: Bell shaped, 0-50 or 0-90 mmHg • Contraction Frequency: Every 2, 3, 5 minutes, or manually triggered • Transducer Sensitivity: 5 µV/V/mmHg or 40 µV/V/mmHg Auto Presets: Unlimited number of user-defined simulation setups can be programmed into the vPad-A1. Specifications/Chapter 1 # Page 8...
OPERATORS MANUAL 1.3 Pulse Oximetry (SpO2) Testing Pulse oximetry or SpO2 testing is provided by the vPad-O2 module of vPad-A1. Saturation (SpO2): • Range: 30 to 100% SpO2* • Increments: 1% • Accuracy: ±1 count + specified accuracy of the DUT when within DUT specified range •...
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OPERATORS MANUAL Signal Artifact: • Simulations: Movement Tapping (Spike Artifact) Shivering (Tremor artifact) Shake Table (2.5Hz Sinewave) AutoSettings: • Defaults: Normal Adult Hypoxia Tachycardia Bradycardia Low Perfusion No Perfusion Movement Artifact Neonate Tremor (Shivering Artifact) • User-defined Presets: Unlimited Alarm Tests: •...
OPERATORS MANUAL 1.4 Non-Invasive Blood Pressure (NIBP) Simulation Non-invasive blood pressure or NIBP simulation is provided by the vPad-BP module of vPad-A1. Power Supply: • Three (3) Lithium Ion batteries, rechargeable, 3.8V 2600 mAh each Simulation Specifications NIBP General: •...
OPERATORS MANUAL Overview vPad-A1™ is a test instrument intended to provide a means of functional testing for Pulse Oximeters, Multi-Parameter Monitors (including some Fetal Monitor parameters), and Non-Invasive Blood Pressure Monitors. When fully equipped with the available modules, the instrument is capable of simultaneously simulating all vital signs, including electrocardiogram, respiration, temperature, cardiac output, blood oxygen saturation, and blood pressure as measured invasively or non-invasively.
OPERATORS MANUAL 2.2 Tablet User Interface The user interface of vPad-A1 is a tablet computer which runs the Google Android™ platform. The use of an Android-based tablet provides several notable benefits: • High resolution, full color display • WiFi / Internet communication •...
OPERATORS MANUAL 2.5 Target Device Customization vPad-A1 comes equipped with an extensive list of test definitions for devices, organized by SpO2 NIBP make and model, that generate precise signals which are matched to the chosen device. In the event that a...
OPERATORS MANUAL Setup vPad-A1 is a modular system having a and one, two or three additional modules which provide patient Base simulation or monitor testing. This chapter describes the modules and their connector interfaces, and provides instructions for assembly and setup of the system.
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OPERATORS MANUAL The vPad-O2 ( ) module is a pulse oximeter SpO2 tester which connects to the module via a Base minDIN8 connector. This module provides an artificial ‘finger’ containing light guides which convey light to or from pulse oximeter probes and sensors.
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OPERATORS MANUAL The vPad-PS (Patient Simulator) module snaps in below the module, Base connecting to power and data communication lines through contacts on the bottom of the Base Figure 3 Item Name Description IBP Connection 2 channel IBP connectors, USB Type A, proprietary wiring (right...
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OPERATORS MANUAL The vPad-BP ( ) module draws power NIBP from an internal set of three rechargeable batteries. The module’s operation can be controlled through a direct connection with , or by means of a pass-through Base connection in the vPad-PS module when used in the stacked configuration.
OPERATORS MANUAL 3.2 Assembly and Setup To prepare vPad-A1 for use, first remove the from its cradle. Tablet Figure 5 Next, connect as many simulation modules to the as necessary. The modules Base vPad-PS vPad-BP slide and snap underneath the unit as shown in the figure below.
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Tablet should boot up and eventually show the Home screen within 20 seconds. Launch the Tablet vPad-A1 App to set up and operate vPad-A1; the patient simulator is controlled wirelessly, via Bluetooth. Figure 9 Figure 10 Note: Once the patient simulation has been set up with the...
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OPERATORS MANUAL Make connections between the patient monitor under test and the simulation/test modules of vPad-A1. module: vPad-PS • ECG – snap connectors/adapter • Respiration – same as above • Temperature – TEMP connector • Cardiac Output – AUX/CO connector •...
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Port on the the using the microUSB cable provided with vPad-A1. Base Figure 14 Figure 15 If the vPad-A1 will not be in use for an extended period of time, exit the and switch the unit A1 App Base and the OFF.
OPERATORS MANUAL Manual Operation vPad-A1™ is a test instrument designed to provide a means of functional testing for Multi-Parameter Monitors, including ECG, Respiration, Temperature, Cardiac Output, and Invasive Blood Pressure (IBP), and some Fetal Monitor parameters; Pulse Oximeters (SpO2); and Non-Invasive Blood Pressure (NIBP) Monitors.
Home adopts typical Android conventions for receiving user input, as outlined in the following sections. 4.1.2 Parameter Selection vPad-A1 comprises three test modules: the Multi-Parameter Patient Simulator ( ), the pulse oximeter vPad-PS or SpO2 tester ( ), and the NIBP simulator ( ).
OPERATORS MANUAL 4.1.3 Parameter Values and Options Simulation settings may have anywhere from two choices (e.g. Adult vs. Neonatal ECG ) to hundreds Mode of possible values (e.g. ECG , adjustable from 20 to 360 BPM in 1 BPM steps). The manner of Heart Rate user input depends on the number of choices available.
OPERATORS MANUAL To set a parameter one time only, touch the “Enter Value” box on the menu to display the soft keyboard at the bottom of the screen. Type the number and press “Done” on the keyboard. Provided the entered value is valid for the given parameter, it will be set when the “Accept” button at the bottom of the menu is pressed.
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OPERATORS MANUAL Figure 25 Figure 26 A downward arrow within a grey box indicates that touching the box will display a list of options. Figure 26 shows the pop-up list that appears for choosing an waveform. Arrhythmia Figure 26...
OPERATORS MANUAL 4.2 ECG 4.2.1 General The vPad-A1's menu provides a means to output , generally ECG Waveforms in the 0 - 5.5 mV range, that are representative of a physiological state or condition of the human heart. This menu also accesses...
OPERATORS MANUAL Figure 27 Referring to , the middle of the screen provides a group of common parameters that can be modified. Some waveforms may not allow a certain parameter to be changed, in which case the parameter's button is shown in grey and is disabled.
OPERATORS MANUAL 4.2.4 Arrhythmias is a group of simulations that test a monitoring system's Arrhythmia ability to correctly display and/or classify signals which are the result of an abnormal cardiac condition. There are over 60 waveforms available in the section.
OPERATORS MANUAL 4.2.5 Pacemaker Pulses simulation tests a patient monitor's ability to correctly display Pacemaker Pulse and/or classify rhythms which include cardiac beats accompanied by artificial pacing pulses having significantly greater amplitude than a normal QRS complex. simulations is fixed, as the frequency is an...
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OPERATORS MANUAL Pacemaker Waveform / Rhythm Description Atrio-Ventricular Sequential AV-sequential-pacemaker wave with continuous paced beats, each with an atrial pulse and a P wave followed by a ventricular-paced pulse and QRS response (75 BPM) Asynchronous 75 BPM Asynchronous pacemaker wave with continuous ventricular-paced beats (75 BPM)
OPERATORS MANUAL 4.2.6 Fetal ECG Signal function simulates heart beat signals obtained from the ECG leads on a direct fetal probe. Fetal ECG parameters are similar to simulations as described in section 4.2.3, except that the Fetal ECG Rate setting has a more limited range, and the setting is fixed.
OPERATORS MANUAL 4.2.8 QRS Detection feature generates standalone QRS complexes that act as triggers QRS Detection for pulse detection and rate measurement. settings are provided, similar to , though the Amplitude Rate Rate selections are more limited. settings are not available.
OPERATORS MANUAL 4.2.10 ST-Segment Elevation simulates regular NSR waves with ST-segments that are offset from the baseline. Of ST-Segment Elevation the common ECG parameters, only are available for this test. The is fixed at Amplitude Artifact Rate 60 BPM.
RA lead to the LA lead, or alternatively from RA to the LL lead. The simulation imitates the expansion and collapse of a patient’s chest while breathing. To access the simulation, touch the Respiration Figure 17 tab on the left side of the vPad-A1 screen ( RESP Main 4.3.2 Parameters parameters can be accessed from a dropdown menu.
OPERATORS MANUAL It can be set from 0.05 to 1.0 ohms in 0.05 ohm increments, and from 1.0 to 5.0 ohms in 0.25 ohm increments. 4.3.2.4 Lead Selection parameter selects the ECG leads across which the simulated Leads Impedance Variation applied.
Figure 50 An optional box (#8000-454) is required to Cardiac Output Adapter interface vPad-A1 with the cardiac catheter and injectate temperature probe of the monitor under test. This is compatible with Baxter (Edwards) catheters and CO Adapter equivalent models from other manufacturers such as Abbott and Viggo-SpectraMed. These...
OPERATORS MANUAL Also on the box is a larger, four-pin connector for the typical temperature CO Adapter Injectate probe. To determine if your device connection requires an additional adapter, contact your Datrend dealer for assistance. Note : Since it is not possible to display a selector or button for every...
OPERATORS MANUAL 4.4.2.5 Cardiac Output – Simulation Curve sets the shape of the temperature variation as blood Simulation Curve temperature downstream is cooled due to and then Injectate Temperature returned to . Users can choose from a set of regular...
Figure 17 To access the IBP simulation, touch the tab on the left side of the vPad-A1 screen ( Main On selection, the simulation setup menu will be displayed, activating the individual parameter values shown on the screen.
The second dropdown list allows selection of Channel 1 , and Channel 2 Simulation Artifacts Transducer Sensitivity controls the port of vPad-A1, and Channel 1 Simulation IBP1 Channel 2 controls the port. The channels are independent in this Simulation...
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OPERATORS MANUAL CHANNEL 1 ONLY • Swan-Ganz AUTO 15 sec (Manual Pause) • Swan-Ganz AUTO 25 sec (Manual Pause) • Swan-Ganz Cycle (Manual Advance) Swan-Ganz cycles are only available for . These options simulate the insertion Channel 1 Simulation and extraction of a Swan-Ganz catheter.
( ) is selected. Static Dynamic Pressure-ECG Timing selects a pre-defined synchronization pattern which is then used for the current simulation. When vPad-A1 generates an waveform, it also changes the pulse so that the fetal Rate Fetal ECG monitor can plot a “rate waveform/trend” that has the same period as the pressure wave.
( SpO2 Main 4.6.2 Manufacturer and Model vPad-A1 incorporates targeted functional tests for a number of existing pulse Figure 64 oximetry systems, organized by the name of their . To Manufacturer...
OPERATORS MANUAL Note To add a new , or not found in the Manufacturer Model Sensor Calibration: SpO2 R- existing options, refer to section 4.8.2.3 - Curves Contained within the menu is an item called , which is a...
OPERATORS MANUAL 4.6.3.4 Artifact dropdown menu displays a selection of noise signals that can be Artifact superimposed over the normal signal. An can be used, for SpO2 Artifact instance, to test the ability of an oximeter to function correctly in a noisy environment.
OPERATORS MANUAL Figure 71 For example, in , only is enabled for the “Low Saturation” test type since it is the SpO2% critical parameter responsible for this . Users may adjust the parameter to a level Alarm Condition that will trigger an alarm from the pulse oximeter. All other parameters are fixed and must remain...
OPERATORS MANUAL 4.6.4.4 Recovery The “Time to Recover” box will begin counting up in number of seconds. This keeps track of the amount of time required to recover from the Alarm Condition . Pressing the button in this state indicates that the pulse oximeter Normal Condition has ceased to alarm.
To fully test a monitor that measures , the A1 provides multiple test features that can be accessed by NIBP Figure 17 touching the tab on the left side of the vPad-A1 screen ( NIBP Main 4.7.2 NIBP Simulation on the A1 injects small pulsatile pressure waves into a test...
OPERATORS MANUAL 4.7.2.1 Heart Rate parameter sets the frequency of pulses during an . It can be set Heart Rate NIBP Simulation from 20 to 240 beats per minute (BPM), in increments of 1 BPM. 4.7.2.2 Pulse Volume refers to the parameter that sets the overall size of the simulated pulses. A simulation Pulse Volume with “High”...
OPERATORS MANUAL Note : To add a new not found amongst existing options, refer Simulation Calibration: NIBP Envelopes to section 4.8.2.4 - 4.7.2.6 Running NIBP Simulations When setup is complete, the button prepares the NIBP Simulation simulator hardware for an impending test. Blood pressure cuff inflation and...
OPERATORS MANUAL 4.7.3 Pressure Source and Manometer ) feature can be used to verify the Pressure Source and Manometer Pressure pressure transducers in a monitor, or other pressure-measuring devices. NIBP parameters are not active during setup. Access the feature setup page by...
, the display unit can be changed to any of the Mode following: mmHg, inHg, kg/cm , cmH O, mBar, PSI, inH O, or kPa. vPad-A1 will hold the pneumatic system pressure until user assigns Figure 86 - Manual Mode Test Manual Operation/Chapter 4 # Page 59...
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Maximum . Result assignment (PASS/FAIL) buttons are Pressure subsequently enabled. , vPad-A1 will actively maintain the pressure Maximum Pressure level until user assigns a Figure 87 Note It is recommended that users exit the...
OPERATORS MANUAL 4.7.4 Over Pressure and Pop-Off feature is intended to test the pressure relief valve limits in an Over Pressure monitor. A typical test routine involves pumping air into the pneumatic NIBP system until the high pressure triggers the relief valve, which will then vent the system to a safe pressure level.
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OPERATORS MANUAL When an test is started, it attempts to pump air into the Over Pressure pneumatic system until the relief valves are triggered. If the A1 senses a valve trigger, it will immediately stop pumping and allow the...
OPERATORS MANUAL 4.7.5 Leakage Rate test assesses the rate at which air leaks from a pneumatic system, Leakage Rate typically by inflating up to and then holding a certain pressure for a predetermined amount of time. parameters are not active during setup. Access the feature setup page...
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OPERATORS MANUAL button can abort the test at any time. The test can then be restarted Leakage Rate with the button on the setup page. At the beginning of an test, the A1 will begin pumping air into the pneumatic system...
Timer/Stopwatch AutoSequence AutoSetting Time Mode 4.8.2 App Settings menu includes features which enable users to optimize performance of vPad-A1. It is Settings Figure 17 accessible by touching the button on the A1 screen ( Main 4.8.2.1 Power Management...
• - for testing/troubleshooting with emulated A1 hardware Demo Mode - cannot be used for actual simulation or performance testing • - for wired USB connection with the vPad-A1 module USB (to A1 base) Base - follow instructions in ? •...
Individual R-Curves are derived through clinical studies and, while similar, may be different for each make and model encountered. vPad-A1 has pre- R-Curves programmed for a number of common monitor makes and models;...
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OPERATORS MANUAL • is not showing an adequate signal level of 50% to Signal Strength 70%, then: - Change sensor position on the simulated finger; or - Change (see below) Input Gain Adjust Input Gain (Optional) • should generally be set to “Auto” (automatic gain Input Gain adjustment).
OPERATORS MANUAL Save R-Curve Data • button will save the entered R-Curve data to a new or existing device entry as identified by the , and (optional) fields on the menu. Manufacturer Model Sensor • button will discard all entered data without saving.
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OPERATORS MANUAL PML PMH Dia. Sys. P-Low P-Hi Each time a change is made to an inflection point, users must press button for Envelope the new parameters to take effect. A typical customization makes the following adjustments through experimentation, in no Envelope particular order.
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OPERATORS MANUAL Figure 105 buttons in change the selected point's pressure, and buttons change its amplitude. button displays the current maximum pulse height, which AMAP defines the largest simulated pulse that vPad-BP will produce during . If the device requires smaller pulses (e.g. the...
OPERATORS MANUAL Figure 106 After saving or when the button in is pressed, the interface returns to the Figure 103 “Customize Envelope” screen in and users can continue working on the same Envelope Pressing the "Escape" button on that screen will dismiss the tool and return to NIBP simulation settings.
OPERATORS MANUAL 5 Automation and Test Records This chapter explains how to use vPad-A1 to perform testing of multi-parameter patient monitors, pulse oximeters, and/or NIBP monitors, following a predefined sequence of steps referred to as an . The generation and management of...
OPERATORS MANUAL 5.1.1 Sync Mode Whenever the A1 is used as a completely assembled system, it is possible to synchronize the signals from all three simulator modules by activating the control on the A1 screen. The feature Main Sync Mode ensures that all heart signals are triggered simultaneously and share a common .
OPERATORS MANUAL Some parameters that are recorded can not be changed, as they represent fixed values of the simulation. An example of a fixed parameter is . If it is necessary to record an Figure 109 ECG Artifact observation, for example the...
Description Manufacturer , and . With vPad-A1, it is possible Model Serial Number Location Facility to enter and save this information on the...
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OPERATORS MANUAL If the database contains no matching entry, then the lookup window will display a search failure message and the match list will be blank. To start a new search, simply enter new text into the box in the lookup...
Record Manager Tablet independently of the vPad-A1 app. may be used to copy, print, and/or delete Test Record files saved by vPad-A1. Record Manager can also be used to convert Test Records to Adobe PDF documents. Record Manager...
5.2 Test Automation 5.2.1 AutoSettings vPad-A1 is designed to work in both manual and automated mode. For any given type of simulation (e.g. ) there are a number of parameter values that define the simulated state (e.g. ECG Normal Sinus Rhythm , and ).
OPERATORS MANUAL When creating an , you have an opportunity to create an AutoSetting that will be visible to the user when on the screen. Press Instruction Results button to make the Instructions dialog visible. Touch inside Edit Instr.
Figure 123 Touching the selection box will display the list of available AutoSequences. By default, the vPad-A1 will have a number of sample AutoSequences pre-installed. Note that these are examples for illustrative purposes only and they can be freely revised, copied or deleted by the user. New...
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OPERATORS MANUAL When a valid has been selected, the AutoSequence button will launch the form. It allows users Equipment Information to enter details on the equipment being tested, as described in Entering Equipment Information section 5.1.2.3 - . To delay this...
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OPERATORS MANUAL interface displays all active parameter settings for so that users can view them Test Result Creating Test Results as reference to check the ’s performance. Refer to section 5.1.2.1 - further details on working with the interface.
OPERATORS MANUAL 5.2.2.2 Creating and Editing AutoSequences After an has been selected from the list, its name will be displayed in the menu box AutoSequence and the button will be enabled (turned from gray to green). At this point this AutoSequence available for editing.
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OPERATORS MANUAL Starting at the top of the screen, the are organized by their corresponding A1 AutoSettings simulator modules. • Patient Simulation (vPad-PS) • SpO2 (vPad-O2) • NIBP (vPad-BP) • Tools (none) Each of these categories will contain the...
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OPERATORS MANUAL section of the presents tools for Action Controls Editor working with the active entry. AutoSequence Group AutoSetting Touching and holding a name bar will allow users to edit the Group name of the . The can be enlarged by...
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Editor Note that vPad-A1 can be further automated when used in conjunction with vPad-Check and the VPL procedure system. Refer to the vPad-Check manual (MN-084 vPad-Check Operators Manual, Chapter 4.2 for further details), in particular regarding the use of the statement.
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OPERATORS MANUAL Automation and Test Records/Chapter 5 # Page 88...
Use of other cleaning agents on the touchscreen may result in scratching, discolouration, streaking or even failure. Electrical safety protection of the operator may be compromised if the instructions in this manual are not followed, or if vPad-A1 is used for a purpose not specified in this manual.
OPERATORS MANUAL APPENDIX A. Sample Test Record This appendix provides an example of a vPad-A1 Test Record, illustrating the Result representation for test setup and user entered numerical data, as well as additional comments. Note The sample Test Record was generated in .
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OPERATORS MANUAL vPad-A1 Simulator Datrend Systems Inc. File: P24601_20160926_125522_P.txt Date: 2016 Sep 26 Time: 12:55:22 vPad ID: vPad-A1: VBU-DEMO-BU,2016-09-26 VSM-DEMO-PS,2016-09-26 VSP-DEMO-O2,2016-09-26 VBP-DEMO-BP,2016-09-26 Equipment Information... Control Number: P24601 Description: PATIENT MONITOR Manufacturer: MED CORP Model: S9001 Serial Number: 30624700 Location:...
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