MN 103d 6100 086 VPad A1 Operators Manual
MN 103d 6100 086 VPad A1 Operators Manual
MN 103d 6100 086 VPad A1 Operators Manual
vPad-A1
All-in-One Patient Simulator
and Performance Tester
Operating Manual
MN-103d
vPad-A1 ™
All-in-One Patient Simulator and Performance Tester
Operating Manual
Copyright
Datrend System s Inc. (“DSI”) agrees to a lim ited copyright release that allows you to reproduce m anuals and
other printed m aterials for use in service training program s and other technical publications. If you would like
other reproductions or distributions, subm it a written request to Datrend System s Inc.
Claims
Our routine m ethod of shipm ent is via com m on carrier. Upon delivery, if physical dam age is found, retain all
packing m aterials in their original condition and contact the carrier im m ediately to file a claim .
If the instrum ent is delivered in good physical condition but does not operate within specifications, or if there are
any other problem s not caused by shipping dam age, please contact your local sales representative or DSI
im m ediately.
Return Procedure
Every product returned for refund/credit m ust be accom panied by a Return Material Authorization (RMA)
num ber, obtained from Datrend Custom er Service. All item s being returned m ust be sent prepaid (freight, duty,
brokerage, and taxes ) to our factory location.
Restocking Charges
Products returned within 30 days of original purchase are subject to a m inim um restocking fee of 15%. Products
returned in excess of 30 days after purchase, but prior to 90 days, are subject to a m inim um restocking fee of
20%. Additional charges for dam age and/or m issing parts and accessories will be applied to all returns.
Products which are not in “as new” and resalable condition, are not eligible for credit return and will be returned
to the custom er at their expense.
Certification
This instrum ent was thoroughly tested and inspected and found to m eet DSI’s m anufacturing specifications
when it was shipped from the factory. Calibration m easurem ents are traceable to the National Research Council
of Canada (NRC) and/or the National Institute of Standards and Technology (NIST). Devices for which there are
no NRC/NIST calibration standards are m easured against in-house perform ance standards using accepted test
procedures.
Page i
W arranty
Datrend System s Inc. ("DSI") warrants the Base and Sim ulation Modules of vPad-A1 (the "Datrend product") to
be free from defects in m aterials and workm anship under norm al use and service for one (1) year from the date
of original purchase. This warranty will be autom atically extended to tw o (2) years from the date of original
purchase, provided that calibration is perform ed on an annual basis by a Datrend Authorized Service Center*.
During the warranty period DSI will, at our option, either repair or replace defects in m aterials and workm anship
at no charge; provided the Datrend product is returned (shipping, duty, brokerage and taxes prepaid) to DSI.
Any and all transportation charges incurred are the responsibility of the purchaser and are not included within
this warranty. This warranty extends only to the original purchaser and does not cover dam age from abuse,
neglect, accident or m isuse or as the result of service or m odification by other than DSI. IN NO EVENT SHALL
DATREND SYSTEMS INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES.
No warranty shall apply when dam age is caused by any of the following:
! Power failure, surges, or spikes,
! Dam age in transit or when m oving the instrum ent,
! Im proper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or m isuse of the instrum ent,
! Fire, water dam age, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.
Only serialized products (those item s bearing a distinct serial num ber tag) and their accessory item s are
covered under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT
COVERED UNDER THE W ARRANTY. Item s such as cables and non-serialized m odules are not covered
under this warranty.
This warranty gives you specific legal rights and you m ay have other rights, which vary from province to
province, state to state, or country to country. This warranty is lim ited to repairing the instrum ent to DSI's
specifications.
W hen you return an instrum ent to DSI for service, repair or calibration, we recom m end shipm ent using the
original shipping foam and container. If the original packing m aterials are not available, we recom m end the
following guide for repackaging:
! Use a double-walled carton of sufficient strength for the weight being shipped.
! Use heavy paper or cardboard to protect all instrum ent surfaces. Use non-abrasive m aterial around all
projecting parts.
! Use at least four inches of tightly packed, industrial-approved, shock-absorbent m aterial all around the
instrum ent.
DSI will not be responsible for lost shipm ents or instrum ents received in dam aged condition due to im proper
packaging or handling. All warranty claim shipm ents m ust be m ade on a prepaid basis (freight, duty, brokerage,
and taxes). No returns will be accepted without a Return Materials Authorization ("RMA”) num ber. Please
contact Datrend (refer to Chapter 6 of this m anual) to obtain an RMA num ber and receive help with
shipping/custom s docum entation.
* Subject to som e exclusions, based on sales territory. Contact Datrend for details.
Page ii
W arranty Disclaimer
Should you elect to have your instrum ent serviced and/or calibrated by som eone other than Datrend System s or
an Authorized Service Centre, please be advised that the original warranty covering your product becom es void
when the tam per-resistant Quality Seal is rem oved or broken without proper factory authorization. W e strongly
recom m end, therefore, that you send your instrum ent to Datrend System s or an Authorized Service Centre for
service and calibration, especially during the original warranty period.
In all cases, breaking the tam per-resistant Quality Seal should be avoided at all cost, as this seal is the key to
your original instrum ent warranty. In the event that the seal m ust be broken to gain internal access to the
instrum ent (e.g., in the case of a custom er-installed firm ware upgrade), you m ust first contact Datrend System s
at 1-604-291-7747. You will be required to provide us with the serial num ber for your instrum ent as well as a
valid reason for breaking the Quality Seal. You should break this seal only after you have received factory
authorization. Do not break the Quality Seal before you have contacted us! Following these steps will help
ensure that you will retain the original warranty on your instrum ent without interruption.
W ARNING
Unauthorized user m odifications or application beyond the published specifications m ay result in electrical
shock hazards or im proper operation. Datrend System s will not be responsible for any injuries sustained due to
unauthorized equipm ent m odifications.
DSI DISCLAIM S ALL OTHER W ARRANTIES, EXPRESSED OR IM PLIED, INCLUDING ANY W ARRANTY OF
M ERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.
Note: Calibration of Datrend products typically involves adjustm ent of param eters stored in firm ware by proprietary
software. Parties other than Datrend and its Authorized Service Centers are lim ited to verification of the status of
the accuracy of the instrum ent. Do not confuse verification with calibration.
Page iii
Page iv
vPad-A1 OPERATORS MANUAL
Table of Contents
ABBREVIATIONS AND DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII
SYMBOL DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX
1 SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 General Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Multi-Parameter Patient Simulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3 Pulse Oximetry (SpO2) Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Non-Invasive Blood Pressure (NIBP) Simulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2 OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 Modular Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2 Tablet User Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 AutoSettings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.4 AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.5 Target Device Customization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3 SETUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.1 Modules and Interfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.2 Assembly and Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4 MANUAL OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.1 Overview of Manual Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.1.1 Patient Simulator App. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.1.2 Parameter Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.1.3 Parameter Values and Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1.3.1 Button Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1.3.2 Numerical Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1.3.3 Pop-up and Dropdown Lists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2 ECG.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.2.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.2.2 Waveforms and Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.2.3 Normal Sinus Rhythm (NSR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.2.4 Arrhythmias.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.2.5 Pacemaker Pulses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.2.6 Fetal ECG Signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.2.7 Performance Waves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.2.8 QRS Detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.2.9 R-Wave Detection.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.2.10 ST-Segment Elevation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.2.11 Tall T-Wave. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.3 Respiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.2 Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.2.1 Breath Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.2.2 Baseline Impedance.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.2.3 Impedance Variation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3.2.4 Lead Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.3.2.5 Inspiration/Expiration Ratio.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.3.2.6 Apnea.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.4 Temperature/Cardiac Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.2 Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.2.1 Temperature.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.2.2 Cardiac Output Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.4.2.3 Cardiac Output – Baseline Temperature. . . . . . . . . . . . . . . . . . . . . . . . . 42
4.4.2.4 Cardiac Output – Injectate Temperature. . . . . . . . . . . . . . . . . . . . . . . . . 42
4.4.2.5 Cardiac Output – Simulation Curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.5 Invasive Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.5.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.5.2 Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.5.2.1 Static Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.5.2.2 Dynamic Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.5.2.3 Intra-Uterine Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.6 Pulse Oximetry (SpO2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.6.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.6.2 Manufacturer and Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.6.3 Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.3.1 Blood Oxygen Saturation.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.3.2 Heart Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.3.3 Pulse Amplitude. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.3.4 Artifact. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.6.4 Alarm Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.6.4.1 Test Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.6.4.2 Alarm State. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.6.4.3 Alarm Stablization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.6.4.4 Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.7 Non-Invasive Blood Pressure (NIBP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.7.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.7.2 NIBP Simulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.7.2.1 Heart Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.7.2.2 Pulse Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.7.2.3 Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.7.2.4 Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.7.2.5 Simulation Envelope Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.7.2.6 Running NIBP Simulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.7.3 Pressure Source and Manometer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.7.3.1 Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
ìA Micro-am pere
A Am pere
EUT Equipm ent Under Test. The electrical device being tested.
Hz Hertz
kHz kilohertz
V Volt
Vrms Volts rm s
Symbol Definitions
The following sym bols m ay be found on vPad-A1:
The operating m anual provides valuable inform ation on the proper use of vPad-A1. It is highly recom m ended
the operator read the instructions thoroughly before operating the device. It m ay be possible to dam age the
Equipm ent Under Test (EUT) and/or cause harm to the operator if vPad-A1 is used incorrectly.
vPad-A1 is a com plex instrum ent which contains Lithium Ion batteries and associated charging circuitry.
Failure to observe appropriate m easures when the instrum ent has been opened, or failure to reassem ble
correctly m ay com prom ise the safety of the user.
Definitions # Page ix
vPad-A1 OPERATORS MANUAL
Definitions # Page x
vPad-A1 OPERATORS MANUAL
1 Specifications
The vPad-A1 All-In-One patient simulator and performance tester is a modular, stackable system comprised
of a user interface or "base" module providing a tablet computer, system power and communications, and
one or more of the following modules: a patient simulator (ECG, IBP, RESP, etc.); a pulse oximeter (SpO2)
tester; and an NIBP simulator. Each simulation/test module can be used individually with the base, or in
combination with either or both of the other modules. 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.
The following specifications pertain to the vPad-A1 hardware when used with the vPad-A1 software or
"app" on the tablet. As a modular system, product capabilities will depend on the modules present;
specifications apply only to those modules that you have active in the system.
User Interface:
The simulation hardware of vPad-A1 is controlled by a tablet computer through a hardwired
connection to the microUSB port on the tablet, or alternatively through wireless communication
with the tablet over Bluetooth. The tablet computer is comparable in size to a conventional
smartphone and fits into a cradle on the vPad-A1 base module for storage and transport.
A software application or "app" running on the tablet controls the system. As individual simulation
functions are activated by the app, they remain active until explicitly turned off. The app enables
numerous simulations to run concurrently, with all patient signals remaining in synchronization.
Specifications/Chapter 1 # Page 1
vPad-A1 OPERATORS MANUAL
Environment:
• 10°C to 40°C (50°F to 104°F)
• 10% to 90% Relative Humidity
• Indoor Use Only
Power Supply:
• Internal Lithium Ion batteries (rechargeable, 3.8V 2600 mAh each), or
• AC adapter, Input: 90-240VAC 50/60Hz
Output: 15 VDC, 2.67A, 40W
Electrical Interfaces:
• 10 standard ECG snap leads
• Optional, externally-connected ECG jacks x 10 (accepts 3 mm or 4 mm plugs)
• BP 1 and BP 2: USB Type A connector, proprietary wiring
• TEMP: 6-pin mini-DIN
• AUX: 8-pin mini-DIN, to optional Cardiac Output and/or Mechanical Fetal Heart
• High-level ECG Out: 2.5mm stereo phono jack
• DACOM: 2 x RJ-12 jack, proprietary serial data interface for Datrend vPad products
• Base USB: microUSB connector (5VDC/2A)
• Tablet USB: mini/microUSB combined connector (5VDC/1A)
• DC IN: 2.1 mm coaxial power jack, to AC Adaptor (15VDC, 2.67A, 40W)
Specifications/Chapter 1 # Page 2
vPad-A1 OPERATORS MANUAL
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
• High Level Output: Lead II amplitude x 500 (0.5V per Lead II millivolt)
• Amplitude Accuracy: ± 2% (Lead II, 2 Hz Square Wave)
• QRS width: 80 msec (Adult) or 40 msec (Neonatal)
• Artifact: 50 Hz, 60 Hz, Muscle, Baseline (wander), Respiration
C Rate Accuracy Better than 0.1%
Amplitude
Lead 1 70 V1 65
Lead 2 100 V2 100
Lead 3 30 V3 110
V4 130
V5 120
V6 90
• Axis Deviation: Normal (intermediate), horizontal, and vertical
Modifies ECG baseline during arrhythmias
Specifications/Chapter 1 # Page 3
vPad-A1 OPERATORS MANUAL
Arrhythmia:
GENERAL 1
• Asystole 1 • PAC Premature Atrial Contraction
• Asystole 2 • PNC Premature Nodal Contraction
• Asystole 3 • Multifocal PVCs (once)
• PVC1 Bigeminy • Frequent Multifocal PVCs
• PVC1 Trigeminy
• PVC2 Bigeminy
• PVC2 Trigeminy
FIBRILLATIONS
• Coarse Atrial Fibrillation • Coarse Ventricular Fibrillation
• Fine Atrial Fibrillation • Fine Ventricular Fibrillation
Specifications/Chapter 1 # Page 4
vPad-A1 OPERATORS MANUAL
TACHYCARDIA
• Atrial Tachycardia
• Paroxysmal Atrial Tachycardia
• 90 BPM Supraventricular Rhythm
• 120 BPM Supraventricular Rhythm
• 140 BPM Supraventricular Tachycardia
• 150 BPM Supraventricular Tachycardia
• 160 BPM Supraventricular Tachycardia
• 170 BPM Supraventricular Tachycardia
• 180 BPM Supraventricular Tachycardia
• 190 BPM Supraventricular Tachycardia
• 200 BPM Supraventricular Tachycardia
• 210 BPM Supraventricular Tachycardia
• 220 BPM Supraventricular Tachycardia
• 160 BPM Normal Sinus Rhythm
GENERAL 2
• Atrial Flutter • Miss Every 10th Beat, 120 BPM
• Sinus Arrhythmia • Nodal Rhythm
• Miss 1 Beat, 80 BPM • Sinus Bradycardia, <60 BPM
• Miss Every 10th Beat, 80 BPM
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vPad-A1 OPERATORS MANUAL
Respiration:
• Rates: 15 to 150 BrPM incremental with 15 customizable
presets
• Baseline Impedance: 500, 1000, 1500, 2000 ohms on Leads I, II, III
• Apnea Selections: 12, 22, 32 seconds, and continuous (0 BPM)
• Impedance Variation: 0 to 1.0 ohms in 0.05 ohm steps, 1.0 to 5.0 in 0.25 ohm
steps
• Simulation Types: Inspiration:Expiration ratios of 1:5, 1:4, 1:3, 1:2, and
1:1, and Ventilated 1:1
• Lead Reference: LA or LL
Temperature:
• Channels: 2
• Body Temperatures: 20 to 42°C in 0.5°C steps
• Probe Compatibility: YSI series 400 or 700
• Accuracy: ± 0.03°C , ± 0.01°C at 30, 32, 35, 37, 40, 42°C
Pacemaker:
• Simulated Rhythms: - Asynchronous @ 75 BPM
- Demand with frequent sinus beat
- Demand with occasional sinus beat
- A-V sequential
- Non-capture
- Non-function
Specifications/Chapter 1 # Page 6
vPad-A1 OPERATORS MANUAL
• Pacer Pulse Amplitude: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 50,
100, 200, 500 and 700 mV
• Pacer Pulse Width: 0.1, 0.2, 0.5, 1.0, and 2.0 msec
• Pacer Pulse Polarity: Positive or negative
Specifications/Chapter 1 # Page 7
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Cardiac Output:
• Baseline Temperatures: 36, 37 and 38°C.
• Injectate Thermistor Types: - H-P/Philips
- American Edwards/Spacelabs
- Adjustable (default Edwards/Spacelabs at 20°C)
• Injectate Temperatures: 0, 2, 20 or 24°C. Note: 24°C Spacelabs is adjustable
• Cardiac Outputs: 3, 4, 5, 6, and 7 liters/minute
• Simulation Types: - Slow Injection
- Faulty Injection
- L/R Shunt
- Cal Pulse: 1°C for 1 second
Auto Presets:
Unlimited number of user-defined simulation setups can be programmed into the vPad-A1.
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Saturation (SpO2):
• Range: 30 to 100% SpO2*
• Increments: 1%
• Accuracy: ±1 count + specified accuracy of the DUT
when within DUT specified range
• Presets: 6, user-definable
* Range of adjustment and presets may vary according to pulse oximeter specifications
Heart Rate:
• Range: 20 to 300 BPM
• Increments: 1BPM
• Accuracy: ±0.25 BPM in sync mode
±1 BPM otherwise
• Presets: 6, user-definable
Pulse Amplitude:
• Range: 0 to 100%
• Increments: 1% steps
• Accuracy: ±1 %
• Presets: 6, user-definable
Specifications/Chapter 1 # Page 9
vPad-A1 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:
• Defaults: 5 tests:
- Low SpO2
- Low Heart Rate
- High Heart Rate
- Low Perfusion
- Motion Artifact
• User-defined Alarm Tests: Unlimited
Specifications/Chapter 1 # Page 10
vPad-A1 OPERATORS MANUAL
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:
• Simulation Type: Oscillometric method
• Pulse Rate: 20 to 240 BPM
• Rate Accuracy: ± 0.25 BPM in sync mode, otherwise ± 1 BPM
• Amplitude: Hi = 2.0 ml nominal
(~1.25 mmHg into 500 ml cuff)
• Amplitude Range: 0 to 150%
• Amplitude Accuracy: better than 0.5%
• BP Envelope Shift: ± 50 mmHg max
min Diastolic: 15 mmHg
max Systolic: 275 mmHg
• Simulation AutoSettings: Unlimited, and user-definable
Manometer:
• Range: 0.0 to 400.0 mmHg
• Accuracy: ± 0.5 mmHg
• Resolution : 0.1 mmHg
• Units: mmHg, mbar, kPa, inH2O, cmH2O
• Test Modes: Manual
• User-defined Settings: Unlimited
Specifications/Chapter 1 # Page 11
vPad-A1 OPERATORS MANUAL
Pressure Source:
• Range: 10.0 to 400.0 mmHg
• Accuracy: ± 0.5 mmHg
• Resolution : 0.1 mmHg
• Units: mmHg
• Test Modes: Automatic
Manual
Step (definable)
• User-defined Settings: Unlimited
Leak Test:
• Range: 0 to 200mmHg/min
• Inflation: Automatic or Manual
• Pressure: 20 to 400mmHg
• Elapsed Time: 30 to 600 sec
• Presets: Pressure, Elapsed Time
6 each, user-definable values
• User-defined AutoSettings: Unlimited
Over PressureTest:
• Inflation: Automatic or Manual
• Range: 20 to 400mmHg
• Release Time: 1-999 sec
• Presets: Pressure, Release Time
6 each, user-definable values
• User-defined AutoSettings: Unlimited
Standard Accessories:
Specifications/Chapter 1 # Page 12
vPad-A1 OPERATORS MANUAL
2 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.
The vPad-A1's modular design combines full features with light weight and flexibility. While all vital signs
can be simulated simultaneously by a complete All-In-One system, the unique design of vPad-A1 allows the
three individual modules to be separated into independent testers, or to be combined (stacked) into a 2-
module or 3-module system. Users can choose to include only those modules which are necessary for the
tasks at hand.
Simulation modules are controlled by a user interface module (the Base ), which may be connected through
a cable to an individual module or to the top module in a stacked system. The Base holds a 5" tablet
computer (referred to in this document as the Tablet ) which provides the simulator's Graphical User
Interface (GUI). In addition to the Tablet , the Base module provides battery power, a charger port, and a
data communication hub which interfaces with the other three modules of the system. These modules are:
the vPad-PS patient simulator, providing output of ECG, invasive blood pressure, respiration and other
physiological signals; the vPad-O2 pulse oximeter tester; and the vPad-BP NIBP simulator.
In its role as the communications hub of vPad-A1, the Base module enables connection of the simulator to
additional vPad products, such as vPad-ES™, from Datrend Systems. This enables electrical safety testing
to be combined with performance tests provided by the simulator to obtain an integrated, automated system
for preventive maintenance inspection of patient monitoring devices.
The vPad-BP module, due to its higher power requirements, contains its own supplementary battery pack
and charger input. As long as both the Base and the vPad-BP module are connected together, a single
battery charger can supply power for both modules from either charger input.
Overview/Chapter 2 # Page 13
vPad-A1 OPERATORS MANUAL
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:
2.3 AutoSettings
Simulation and testing functions of vPad-A1 have the ability to receive AutoSettings , a combination of
simulation settings representing a scenario or test condition. For instance, the Multi-Parameter Patient
Simulator can have a ‘Hypertensive’ AutoSetting , invoked by a single selection, that generates ECG at a
specific Rate and a particular Amplitude with motion Artifact . Rather than setting each ECG parameter
individually, selection of the Hypertensive AutoSetting would set all of the parameters at once.
Users can configure and save a virtually unlimited number of AutoSettings . Once an AutoSetting has been
created, it can then be used in one or more AutoSequences .
2.4 AutoSequences
There can be a virtually unlimited number of AutoSequence files stored on the tablet.
Overview/Chapter 2 # Page 14
vPad-A1 OPERATORS MANUAL
vPad-A1 comes equipped with an extensive list of test definitions for SpO2 and NIBP devices, organized by
make and model, that generate precise signals which are matched to the chosen device. In the event that a
particular device is not found in the list of models, tools are available in the vPad-A1 App for knowledgeable
users to create new, custom definitions.
There can be a virtually unlimited number of make and model definitions stored on the tablet.
Overview/Chapter 2 # Page 15
vPad-A1 OPERATORS MANUAL
Overview/Chapter 2 # Page 16
vPad-A1 OPERATORS MANUAL
3 Setup
vPad-A1 is a modular system having a Base and one, two or three additional modules which provide patient
simulation or monitor testing. This chapter describes the modules and their connector interfaces, and
provides instructions for assembly and setup of the system.
Fig u re 1
Setup/Chapter 3 # Page 17
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Fig u re 2
Setup/Chapter 3 # Page 18
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Fig u re 3
Setup/Chapter 3 # Page 19
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Setup/Chapter 3 # Page 20
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To prepare vPad-A1 for use, first remove the Tablet from its cradle.
Fig u re 5
Next, connect as many simulation modules to the Base as necessary. The vPad-PS and vPad-BP modules
slide and snap underneath the Base unit as shown in the figure below. The vPad-O2 module connects to
the Base unit via the "SPO2" port.
Fig u re 6 Fig u re 7
Setup/Chapter 3 # Page 21
vPad-A1 OPERATORS MANUAL
When ready to begin testing a patient monitor, power ON the system by depressing the pushbutton switch
located at upper right on the Base . The power LED at top left on the Base should light up and display
green.
Fig u re 8
Switch ON the Tablet by pressing and holding the Power / Screen Lock button for about 5 seconds. The
Tablet should boot up and eventually show the Home screen within 20 seconds. Launch the vPad-A1 App
to set up and operate vPad-A1; the patient simulator is controlled wirelessly, via Bluetooth.
Fig u re 9 Fig u re 10
No te : Once the patient simulation has been set up with the App , it is good practice to turn the Tablet
display OFF temporarily. Quickly pressing and releasing the Power / Screen Lock button on the
Tablet will put its screen into a ‘sleep’ mode. The ‘sleep’ state is not the same as OFF, but it will
reduce power consumption and extend battery life of the Tablet. Momentarily press the same
button again to ‘wake’ the user interface.
Setup/Chapter 3 # Page 22
vPad-A1 OPERATORS MANUAL
Make connections between the patient monitor under test and the simulation/test modules of vPad-A1.
vPad-PS module:
Fig u re 11
vPad-O2 module:
Fig u re 12
Setup/Chapter 3 # Page 23
vPad-A1 OPERATORS MANUAL
vPad-BP module:
Fig u re 13
vPad-A1 is normally used while running on its internal batteries. When the vPad-A1 App indicates that
batteries are low, users should recharge the batteries by connecting the DC power supply and AC power
cord between the Base unit and a mains outlet. The Tablet can be recharged by connecting it to the USB
Port on the the Base using the microUSB cable provided with vPad-A1.
Fig u re 14 Fig u re 15
If the vPad-A1 will not be in use for an extended period of time, exit the A1 App and switch the Base unit
and the Tablet OFF. To power OFF the Tablet , press and hold the Power / Screen Lock button until a
confirmation message appears on the screen, then select the appropriate response to complete the Power
Off sequence. For long-term storage or transport, simply proceed through the setup procedure in reverse
from Fig u re 15 to Fig u re 5 above.
Setup/Chapter 3 # Page 24
vPad-A1 OPERATORS MANUAL
4 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. This chapter details use of simulation features for manual or ad hoc testing of patient monitoring
equipment. Automated testing of patient monitors is covered in section 5.2 - T e s t Au to m atio n .
The vPad-A1 Simulator App (the App ) runs on a 5" Android tablet (the
Tablet ). On initial power-up, the Tablet enters the operating system Home
screen as shown in Fig u re 16. The Home screen contains shortcuts to
several applications installed on the Tablet . An information bar at the top
displays the Tablet ’s current status, including the time of day and battery
level.
Below the blue LCD screen of Fig u re 16, there is a row of three hardware
buttons which are built into the face of the Tablet . The elongated Home
button protrudes from the center of the Tablet ; pressing the
Home button returns the Tablet ’s display to the Home screen of Fig u re
16.
To the left of the Home button is the M enu button. It is also not
visible until pressed. The M enu button shows a context-specific menu, if
Fig u re 16 one is available for the app currently in use.
To begin operating the simulator, follow instructions in 3.2 - As s e m b ly an d Se tu p . The App should start
automatically when hardware setup is complete. If the App does not start automatically on connection of
the hardware, or to restart the App after exiting it, press the icon on the Home screen.
The App adopts typical Android conventions for receiving user input, as outlined in the following sections.
vPad-A1 comprises three test modules: the Multi-Parameter Patient Simulator (vPad-PS ), the pulse oximeter
or SpO2 tester (vPad-O2 ), and the NIBP simulator (vPad-BP ). “Multi-Parameter” in vPad-PS refers to
ECG waveforms, Respiration , Temperature , Cardiac Output , and Invasive Blood Pressure .
Simulations and performance tests can be configured manually or recalled through an AutoSetting . This
section covers methods of manually operating the simulator by choosing and entering new test parameters.
For details on quick, automated testing with AutoSettings and AutoSequences , see section 5.2 - T e s t
Au to m atio n .
On startup, the App will display its M ain screen as shown in Fig u re 17. A
tabbed vertical toolbar on the left edge of the M ain screen lists all the
simulation categories provided, though some may be initially hidden. To
reveal more tab options, touch and drag the vertical bar up towards the
top of the screen. Fig u re 18 shows the M ain screen with the bottom-most
tab visible.
Fig u re 17
Fig u re 18
Simulation settings may have anywhere from two choices (e.g. Adult vs. Neonatal ECG M ode ) to hundreds
of possible values (e.g. ECG Heart Rate , adjustable from 20 to 360 BPM in 1 BPM steps). The manner of
user input depends on the number of choices available.
A parameter which can be adjusted over a range of values may be represented by a group of icons as
shown in Fig u re 20 , or alternatively as shown in Fig u re 21 for certain parameters.
Fig u re 20
Fig u re 21
In either configuration, a button will display the current or active value of the parameter. Touching
the button displays a data entry menu, providing a set of p re s e t v alu e s from which to choose.
If a value is desired that is not in the preset list, users have two options:
you can type the value into the “Enter Value” box and press “Accept”, or
change a preset button to the desired value so it can be used again later.
Fig u re 22
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. If you press “Enter Value” by mistake, you can dismiss the
keyboard without inputting a value by pressing the Back button.
Fig u re 23 Fig u re 24
It is possible to scroll through preset values without displaying the data entry menu of Fig u re 22.
Referring to Fig u re 20 and Fig u re 21, instead of pressing the current value button use the and
buttons to scroll through the presets.
Some parameters such as rate or amplitude can be adjusted incrementally, in steps of ±1 for
example. When these incremental adjustments are possible, the menu will provide and
buttons as shown in Fig u re 21.
Some parameters offer selections in the form of a list that drops down or pops up from the
parameter's indicator. For instance, Arrhythmias are grouped into categories, each with its own list
of waveform options. The gray boxes in Fig u re 25 show the ECG simulation type (for Arrhythmia
waveforms), the current category or group (‘General Waveforms 1'), and the specific waveform
which is currently active (‘PAC Premature Atrial Contraction’).
Fig u re 25 Fig u re 26
A downward arrow within a grey box indicates that touching the box will display a list of options.
Fig u re 26 shows the pop-up list that appears for choosing an Arrhythmia waveform.
A gray scrollbar on the right of a list such as Fig u re 26 indicates that more options can be revealed
by dragging the list up or down.
The currently active option is displayed with a green radio indicator, per Fig u re 26. Touch any
option in the list to select it and dismiss the pop-up. To dismiss the pop-up without selecting an
item, press the Back button at bottom right on the Tablet .
4.2 ECG
4.2.1 General
The vPad-A1's ECG menu provides a means to output ECG W aveforms , generally
in the 0 - 5.5 mV range, that are representative of a physiological state or condition
of the human heart. This menu also accesses Performance W aveforms that can be
used to test transient response, frequency response, and linearity of an ECG
monitoring system.
To enter the ECG menu shown in Fig u re 27, touch the ECG tab on the left side of
the vPad-A1 M ain screen (Fig u re 17 ). Entering the ECG setup screen activates the
parameter values displayed on the screen.
Fig u re 27
ECG W aveforms can be selected from the dropdown lists at the top of the screen.
There may be two or three list menus depending on the type of simulation in use.
The first dropdown menu presents the general category of ECG W aveforms .
Touching the first list box will display a complete list of the selections available, as
shown in Fig u re 28. Each category of ECG W aveform will be explained in the
following sections.
The second dropdown list provides selections that will alter the general shape of the
waveform. Options listed will differ depending on the type of ECG W aveform
selected from Fig u re 28 .
Fig u re 28
Referring to Fig u re 27, the middle of the screen provides a group of common ECG 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.
• The Artifact parameter selects a simulated noise that is superimposed on the ECG W aveform , if
applicable.
No te : When simulation of Intra-Uterine Pressure (IUP, section 4.5.2.3) is active, the IUP simulation
overrides the ECG settings of Fig u re 29 to output a special Fetal ECG waveform. Attempts to
change any ECG settings via the menu of Fig u re 29 will have no effect until a different
Invasive Blood Pressure simulation (Static or Dynamic Blood Pressure ) is selected.
Normal Sinus Rhythm (NSR ) is a basic ECG simulation that tests a patient
monitor's ability to correctly display and/or measure signals as produced by
a normally-functioning heart. This simulation has a range of heart Rates
and signal Amplitudes , two simulation M odes (Adult or Neonatal), as well
as several different Artifacts .
Fig u re 30
Besides the common ECG parameters, NSR also has an Axis setting that
simulates different physical orientations of the heart relative to the positions
of ECG chest leads. Touching the second dropdown list will display the
available selections. Select a list item to set the NSR Axis .
Fig u re 31
4.2.4 Arrhythmias
Fig u re 32
GENERAL 1
• Asystole 1 • PAC Premature Atrial
• Asystole 2 Contraction
• Asystole 3 • PNC Premature Nodal
• PVC1 Bigeminy Contraction
• PVC1 Trigeminy • Multifocal PVCs (once)
• PVC2 Bigeminy • Frequent Multifocal PVCs
• PVC2 Trigeminy
FIBRILLATIONS
• Coarse Atrial Fibrillation • Coarse Ventricular Fibrillation
• Fine Atrial Fibrillation • Fine Ventricular Fibrillation
TACHYCARDIA
• Atrial Tachycardia
• Paroxysmal Atrial Tachycardia
• 90 BPM Supraventricular Rhythm
• 120 BPM Supraventricular Rhythm
• 140 BPM Supraventricular Tachycardia
• 150 BPM Supraventricular Tachycardia
• 160 BPM Supraventricular Tachycardia
• 170 BPM Supraventricular Tachycardia
• 180 BPM Supraventricular Tachycardia
• 190 BPM Supraventricular Tachycardia
• 200 BPM Supraventricular Tachycardia
• 210 BPM Supraventricular Tachycardia
• 220 BPM Supraventricular Tachycardia
• 160 BPM Normal Sinus Rhythm
GENERAL 2
• Atrial Flutter • Miss Every 10th Beat,
• Sinus Arrhythmia 120 BPM
• Miss 1 Beat, 80 BPM • Nodal Rhythm
• Miss Every 10th Beat, 80 BPM • Sinus Bradycardia, <60 BPM
Arrhythmia waveforms that are manually activated will display a Trigger button that
starts a simulation each time it is pressed.
Fig u re 34
The Pacemaker Pulse simulation tests a patient monitor's ability to correctly display
and/or classify rhythms which include cardiac beats accompanied by artificial
pacing pulses having significantly greater amplitude than a normal QRS complex.
The Rate of Pacemaker Rhythm simulations is fixed, as the frequency is an
important characteristic of the chosen waveform. The simulations permit
adjustment of both the QRS Amplitude and baseline Artifact .
Pacer simulation M ode is adjustable between Atrial and Ventricular, which affects
the timing of the pacing pulse that is inserted into the paced waveform.
Besides the common ECG parameters, Pacemaker Pulse has several additional
settings that are accessible through the second dropdown list (Fig u re 36).
Fig u re 35
Fig u re 36
Pacer Rhythm controls the timing of the paced waveform. See the tables which follow for waveform
descriptions. Additional options which are available in Atrial M ode are shown in Fig u re 37. Ventricular
M ode options are shown in Fig u re 38.
Fig u re 37
Fig u re 38
Atrial 80 BPM Atrial pacemaker wave at 80 BPM, with a pacer pulse at the start of each P wave.
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)
and no P waves
Demand with Frequent Sinus Beats A “demand” pacemaker wave with frequent sinus beats (forty normal beats
followed by twenty ventricular-paced beats, repeated) (80 BPM)
Demand with Occasional Sinus A “demand” pacemaker wave with occasional sinus beats (twenty normal beats
Beats followed by forty ventricular-paced beats, repeated) (80 BPM)
Non-Capture Ventricular-paced beats, where one out of ten beats has no heart response (75
BPM)
Fig u re 42
No te : Since it is not possible to display a selector or
button for every simulation parameter at the
same time, the Pacemaker Pulse menu displays,
in yellow, a summary list of all the parameter
settings which are currently in use. See Fig u re
35 for an example of a parameters summary.
Fig u re 40
The Fetal ECG function simulates heart beat signals obtained from the ECG leads on a direct fetal probe.
Fetal ECG parameters are similar to NSR simulations as described in section 4.2.3, except that the Rate
setting has a more limited range, and the M ode setting is fixed.
Performance W aves are a set of standard, periodic signals for testing the performance of an ECG
monitoring system, including transient response, frequency response, linearity and sensitivity.
Only the Amplitude parameter is available for Performance W aves simulations. Rate and M ode settings are
meaningless for these types of waveforms, and Artifact is not applied during performance tests.
Once Performance W aves is selected from the first dropdown list, the second dropdown menu provides a
list of specific waveforms, as shown below:
The QRS Detection feature generates standalone QRS complexes that act as triggers
for pulse detection and rate measurement.
Amplitude and Rate settings are provided, similar to NSR , though the Rate
selections are more limited. Artifact and M ode settings are not available.
Fig u re 43
Although the QRS duration (width of the QRS complex) is adjustable, R and S
waves have relative amplitudes according to specification defined in ANSI/AAMI
standard EC-13.
R wave amplitude 0.875 of the Amplitude setting
S wave amplitude negative 0.125 of the Amplitude
R wave up slope 0.4375 of the QRS duration setting
R wave down slope 0.5 of the QRS duration
S wave up slope 0.0625 of the QRS duration
Touching the QRS Duration button will display a table of preset values. This table
is a subset of the complete list:
Fig u re 44
From: 8 to 20 ms in steps of 2 ms; or
20 to 200 ms in steps of 10 ms
Simpler than the QRS complex, the R-w ave Detection signal may also be used to
rate accuracy of a patient monitor. This is a simple triangular waveform with
adjustable Rate , Amplitude , and Duration . When selected, the top of the screen will
appear as shown in Fig u re 45.
R-W ave Detection parameters behave in exactly the same manner as the QRS Fig u re 45
Detection parameters; the same Duration options are provided.
simulates regular NSR waves with ST-segments that are offset from the baseline. Of
ST-Segment Elevation
the common ECG parameters, only Amplitude and Artifact are available for this test. The Rate is fixed at
60 BPM.
The percentage of ST-segment offset, relative to the ECG Amplitude , is adjustable by changing the ST
Level setting to a value between -150% (below baseline) and +150% (above baseline).
The Tall T-W ave simulation generates large T-waves accompanying standard QRS waves.
Per ANSI/AAMI EC-13, the QRS wave has a width of 100 ms and a QT interval of 350 ms. The T-wave
has a sinusoidal shape, 180 ms wide, and T Height can be adjusted in amplitude from 0 to 150 % of the QRS
waveform amplitude.
The QRS waveform amplitude is adjustable by changing the ECG Amplitude parameter. The Rate for Tall
T-W ave s is fixed at 80 BPM.
4.3 Respiration
4.3.1 General
Respirationis simulated by small, rhythmic variations in impedance across the ECG signal leads, typically
from the 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 Respiration simulation, touch the
RESP tab on the left side of the vPad-A1 M ain screen (Fig u re 17 ).
4.3.2 Parameters
Fig u re 46
4.3.2.1 Breath Rate
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.
The Leads parameter selects the ECG leads across which the simulated Impedance Variation is
applied. Choices are between the RA and LL leads, or alternatively between the RA and LA leads.
The Inspiration/Expiration Ratio (I:E ) defines a relationship between inspiration (inhalation) time
and expiration (exhalation) time, which is an indicator of patient respiratory effort. It can be set to
one of the following options:
4.3.2.6 Apnea
Apnea is the temporary cessation of breathing, which may occur while sleeping or under anaesthesia.
This setting imitates the condition by suspending Respiration simulations for the selected duration.
Available settings are:
4.4.1 General
Temperature and Cardiac Output simulations are combined on the same menu
since both make use of thermistor-based temperature measurements. Their
common setup interface can be accessed by touching the T/CO tab on the M ain
screen (Fig u re 17 ). The topmost dropdown list allows users to select between the
two different simulations.
Fig u re 48
4.4.2 Parameters
4.4.2.1 Temperature
Also on the CO Adapter box is a larger, four-pin connector for the typical Injectate temperature
probe. To determine if your device connection requires an additional adapter, contact your Datrend
dealer for assistance.
Fig u re 51
Baseline Temperature sets the temperature of the patient's blood prior to injection of the saline. It
can be set to 36, 37, or 38 EC.
Fig u re 52
The Simulation Curve sets the shape of the temperature variation as blood
temperature downstream is cooled due to Injectate Temperature and then
returned to Baseline Temperature . Users can choose from a set of regular
curves representing a normal thermodilution routine or from a set of test
curves, as shown in Fig u re 54.
A Start button will appear after choosing a Simulation Curve . Pressing the
button will initiate or restart the simulation.
Fig u re 54
4.5.1 General
The Invasive Blood Pressure (IBP ) simulation provides static pressure settings or dynamic output
waveforms suitable for testing up to two invasive blood pressure channels of a multi-parameter monitor.
To access the IBP simulation, touch the IBP tab on the left side of the vPad-A1 M ain screen (Fig u re 17 ).
On selection, the simulation setup menu will be displayed, activating the individual parameter values shown
on the screen.
4.5.2 Parameters
Parameters related to IBP can be selected from the dropdown lists at the top of the
screen. There are three modes of operation: Static Blood Pressure , Dynamic Blood
Pressure , and Intra-Uterine Pressure . Touching the top-most menu box will
present a list of the options available, as shown in Fig u re 55.
Selecting any of these options will then display a list of relevant parameters for the
second list. Users may set parameters as described in section 4.1.3 - Param e te r
Valu e s an d O p tio n s .
Fig u re 55
Fig u re 56
When Static Blood Pressure (SBP ) is selected from the upper list, the module
will output a single pressure from both of its IBP channels. Touching the
second list displays parameters relevant to static pressure, as shown in Fig u re
57.
Selecting the Constant Pressure parameter will display controls for the static
pressure output. For example, to zero the IBP channels at the start of a Fig u re 57
monitor test, use the button controls in Fig u re 56 to change Constant
Pressure to 0 mmHg.
Selecting Transducer Sensitivity displays a third dropdown list menu. Available options are 5
ìV/V/mmHg and 40 ìV/V/mmHg, each of which affects the baseline and scaling of the output
signal. Users should select the sensitivity suitable for the type of tranducer expected by the monitor.
When Dynamic Blood Pressure (DBP ) is selected from the upper list, the
module can simulate various types of IBP waveforms in synchronism with the
ECG signal. The second dropdown list allows selection of Channel 1 or
Channel 2 Simulation , Artifacts , and Transducer Sensitivity .
Fig u re 59
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 Channel 1 Simulation . These options simulate the insertion
and extraction of a Swan-Ganz catheter. When an “AUTO” cycle is active, the module will
automatically step through the following waveforms and repeat until another IBP simulation is
selected:
A button allows users to stop the cycle from advancing. When pressed, the button is
replaced by a button that resumes the cycle.
If the newly chosen Swan-Ganz option is not “AUTO”, the module will begin simulating the first
waveform in the cycle above but remain in a paused state. It will only advance to the next waveform
in the cycle when the button is pressed.
To simulate noise in DBP waveforms for both channels, select the Artifacts option in the second
dropdown menu. The following selections are available:
Artifact Off
5% for Arterial, Radial, and Left Ventricle waveforms, or 5mmHg for others
10% for Arterial, Radial, and Left Ventricle waveforms, or 10mmHg for others
To change the Transducer Sensitivity, select the parameter from the second dropdown menu and
select a setting from the list that appears. Options available are 5 ìV/V/mmHg and 40
ìV/V/mmHg.
Fig u re 60
No te : When IUP is active, the module overrides the normal ECG settings to output a special Fetal
ECG waveform. Attempts to change ECG settings will have no effect until a different IBP
simulation (Static or Dynamic ) is selected.
The Pressure W aveform setting controls the peak height of the pressure
waveform. Available options are 50 mmHg and 90 mmHg.
Fig u re 61
The Contraction Frequency setting controls the length of time between the
start of each contraction pressure wave: 2 minutes, 3 minutes, or 5 minutes.
If the “Single Contraction” option is chosen instead, users must manually
start each contraction by pressing the button.
Fig u re 62
4.6.1 General
The A1 Patient Simulator provides the ability to simulate the light levels that
specific makes and models of pulse oximeter would expect to receive (based on its
approved clinical trials) for a given range of blood oxygen saturations. Clinical trials
conducted by device manufacturers provide the basis for what is termed the R-
Curve , representing the relationship between the monitor’s detected optoelectronic
signals and ‘gold standard’ hemoximetery measurements, generally performed in a
lab using blood samples taken simultaneously from test subjects. A1 includes R-
Curves for a number of common/popular makes and models of pulse oximetry
technology, either built into their own branded devices or into other systems on an
OEM basis.
Next, touch the icon near the top right corner of the screen. The icon
launches a Favourites Editor, displaying items currently in Favourites . The “Add”
button will enter the selected M anufacturer and M odel (plus Sensor if applicable)
into the list as a new item.
To delete an existing item from the list, highlight an item as shown in Fig u re 67, Fig u re 67
then touch the “Remove” button. When finished, press “Exit” to dismiss the
Favourites Editor . All added items will be listed in the Favourites category under M anufacturer .
4.6.3 Parameters
The target Blood Oxygen Saturation (SpO2% ) setting changes the saturation
reading expected on the DUT . It can be modified over the range of 30 % to
100 %, in 1 % increments.
The Heart Rate parameter sets the frequency of pulse waveforms for SpO2 . It can be set from 20 to
300 beats per minute (BPM), in increments of 1 BPM.
The Pulse Amplitude parameter controls the relative size of the simulated plethysmogram. It can be
set from 0 % (no pulse) to 100 % (normal adult pulse), in steps of 1%.
4.6.3.4 Artifact
The Artifact dropdown menu displays a selection of noise signals that can be
superimposed over the normal SpO2 signal. An Artifact can be used, for
instance, to test the ability of an oximeter to function correctly in a noisy
environment.
Fig u re 69
4.6.4 Alarm Tests
The SpO2 Alarm Test checks a pulse oximeter for its ability to respond to an Alarm
Condition , such as a sudden drop in Blood Oxygen Saturation or a deteriorated
patient signal. There are four stages in an Alarm Test: 1) Test Setup; 2) Alarm State;
3) Alarm Stablization; and 4) Recovery.
The setup stage begins as soon as the SpO2 module is launched from the
tabbed toolbar on the A1 M ain screen. At this time, users should make sure
that the pulse oximeter is displaying stable measurements in agreement with
the active settings of Fig u re 68, and that an alarm is not currently active.
This initial state is called the Normal Condition .
Fig u re 70
The button launches the Alarm Test setup interface. By
default, the screen will display the Normal Condition as copied from the SpO2
parameter setup which is currently in use, per Fig u re 68.
The upper dropdown menu includes a list of Alarm Test types (Fig u re 72 ).
When a test type is selected, the setup interface enables only the controls that
are relevant for that specific Alarm Condition .
Fig u re 71
Fig u re 72
For example, in Fig u re 71, only SpO2% is enabled for the “Low Saturation” test type since it is the
critical parameter responsible for this Alarm Condition . Users may adjust the parameter to a level
that will trigger an alarm from the pulse oximeter. All other parameters are fixed and must remain
the same as for Normal Condition .
Unlike the regular SpO2 setup interface, changes in Alarm Test setup are not reflected immediately
in the generated oximetry signals. The Alarm Condition will be applied after the Alarm Test begins.
When test setup is complete, the button launches a new test interface that guides user
through the chosen Alarm Test . The screen displays a summary of both the Normal Condition and
the Alarm Condition . A single action button appears near the centre of the interface:
When pressed in this initial state, the action button will apply
the Alarm Condition . The test enters the Alarm State.
Fig u re 73
4.6.4.3 Alarm Stablization
Once the alarm has been triggered, the Alarm Test pauses to
allow the Alarm Condition to stablize. During the Alarm
Stablization stage, the action button is disabled. Instead of an
action, it displays a countdown of five seconds. When
countdown is complete, the Alarm Test enters Recovery.
Fig u re 74
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 to
Normal Condition . Pressing the button in this state indicates that the pulse oximeter
has ceased to alarm. The “Time to Recover” timer stops.
At the conclusion of the Recovery stage, the test screen will appear as in
Fig u re 75. The “Time to Alarm” and “Time to Recover” boxes now
contain test data, and the “PASS” and “FAIL” buttons are enabled.
The action button returns to the state so that users can restart
the Alarm Test if desired. Restarting erases existing data and returns to the
Alarm State described in section 4.6.4.2.
Fig u re 75
4.7.1 General
In oscillometric Non-Invasive Blood Pressure (NIBP ) monitoring systems, a patient’s blood pressure is
assessed by inflating a cuff around the patient’s arm. The cuff contains an air bladder that serves two
purposes: one, to compress the arm such that blood flow can be restricted by various degrees; and,
secondly, to convert changes in the arm’s volume into small variations in air pressure within the cuff. Once
a blood pressure measurement is complete, the cuff is deflated.
The pressure variations detected by the monitor are known as oscillometric signals. As shown in human
experiments and repeatedly in clinical trials, the sizes of these oscillometric pulses can be mapped to certain
clinically significant physiological parameters such as Systolic Blood Pressure (SYS ), M ean Arterial
Pressure (M AP ), and Diastolic Blood Pressure (DIA ). In general, the sizes of oscillometric pulses increase
as the cuff is inflated from zero pressure, continue increasing past the DIA, and peaks when the cuff’s
internal pressure is close to the patient’s M AP . When pressure exceeds M AP , pulse sizes will gradually
decrease as cuff pressure rises past SYS , then further until the cuff fully restricts patient blood flow to the
distal portions of the arm.
This relationship between cuff pressure, blood pressure, and the size of oscillometric pulses is known as an
Envelope . As more NIBP monitors meet regulatory approval through clinical trials, they show that there is
not one universal, ideal Envelope as was proposed early in the history of the oscillometric NIBP technique,
but rather a “best fit” relationship that is dependant on the selected trial population.
To fully test a monitor that measures NIBP , the A1 provides multiple test features that can be accessed by
touching the NIBP tab on the left side of the vPad-A1 M ain screen (Fig u re 17 ).
NIBP Simulation on the A1 injects small pulsatile pressure waves into a test
pneumatic system that includes the NIBP monitor, its air hose(es), a blood pressure
cuff, and the simulator. The cuff should be wrapped around a test cylinder or
mandrel that is large enough to make a snug (not tight) fit. Hose adapters allow the
simulator to be connected between the distal end of the hose(es) and the cuff, such
that the injected pulses would appear to the monitor as oscillometric signals.
On the NIBP Simulation page in Fig u re 76, shown by default when first entering
the NIBP tab, users can adjust the simulation parameters that will become active
when the feature is launched with the button.
Fig u re 76
The Heart Rate parameter sets the frequency of pulses during an NIBP Simulation . It can be set
from 20 to 240 beats per minute (BPM), in increments of 1 BPM.
Pulse Volume refers to the parameter that sets the overall size of the simulated pulses. A simulation
with “High” Pulse Volume provides the most reliable readings from the monitor's perspective, since
large oscillometric signals are easier to detect. “Medium” and “Low” Pulse Volume can be used to
test the monitor's ability to handle less strong or generally weak pulse signals from the blood
pressure cuff.
4.7.2.3 Mode
The simulation M ode should be selected to suit the NIBP monitor type.
Available options are “Adult” and “Neonatal”. For a device intended for
monitoring both adults and neonates, the M ode setting should match the
currently selected options on the monitor, along with a cuff of appropriate
size.
4.7.2.4 Device
The Device dropdown menu contains a list of NIBP monitor makes and Fig u re 77 - NIBP
models. Users must select an appropriate target device to ensure that the Device Selection
calibrated Envelopes to be used for NIBP Simulation are suitable for the
monitor's specific oscillometric blood pressure measurement algorithms.
When NIBP Simulation setup is complete, the button prepares the simulator hardware for
an impending test. Blood pressure cuff inflation and deflation are entirely driven by the device
under test, as is the case during a normal diagnostic NIBP measurement. The module will begin
monitoring cuff pressure and display a Result screen as shown in Fig u re 80.
The Result screen displays a summary of the active Simulation parameters along
with fields for entering observed readings. For details on how to enter data for
Test Records , see section 5.1.2 - T e s t Re s u lts . The interface also instructs users
to initiate an NIBP measurement on the patient monitor.
Fig u re 81
If the initial DUT measurement is unsatisfactory, users may elect to make multiple NIBP
measurements. The unit is ready to generate multiple Simulations until user assigns a /
or presses .
No te : It is recommended that users exit the NIBP Simulation Result screen when finished to
conserve battery power.
The Pressure Source and M anometer (Pressure ) feature can be used to verify the
pressure transducers in a NIBP monitor, or other pressure-measuring devices.
Pressure parameters are not active during setup. Access the feature setup page by
swiping right from the NIBP Simulation page (Fig u re 76 ) or swiping left from the
Over Pressure page (Fig u re 88 ), then press when ready.
4.7.3.1 Mode
The M aximum Pressure parameter refers to the highest target pressure for Auto and Step regulation.
It can be set from 10 to 400 mmHg, in 1 mmHg increments. Parameter controls are disabled in
M anual M ode , since users and/or the DUT are in control of system pressure.
The Delay Time controls the pause duration between intermediate pressure
levels in Step M ode . It can be set from 1 to 600 seconds, in 1 second
intervals. Parameter controls are disabled in Auto and M anual M ode .
The Pressure Step parameter sets the size of each intermediate pressure
interval in Step M ode . It can be set from 10 to 400 mmHg, in 1 mmHg
increments. Parameter controls are disabled in Auto and M anual M ode .
For example, in Fig u re 83, the setup page is in Step M ode . Once the test is
started, A1 will inflate system pressure from zero to the M aximum Pressure Fig u re 83 - Pressure
of 100 mmHg. In the process it will pause for 5 seconds Delay Time at Step Mode
every 20 mmHg Pressure Step .
Before starting a Pressure test, first place the NIBP monitor in its service mode or transducer test
mode, as appropriate. When setup is complete, initiate the test in the selected M ode and show the
Result screen by pressing the button.
The Result screen will have slightly different appearance and behaviour depending
on the Pressure test M ode :
• Auto The test begins pumping air into the test pneumatic system. Result
assignment (PASS/FAIL) buttons are disabled until pressure
reaches the M aximum Pressure .
Fig u re 86 - Manual vPad-A1 will hold the pneumatic system pressure until user assigns
Mode Test a / or .
• Step The test begins automatically, raising the system pressure to the
first Pressure Step target. Once the target has been reached, the
Result screen shows a countdown above the Comments box for
the duration of the Delay Time .
No te : It is recommended that users exit the Pressure Result screen when finished to
conserve battery power.
The Over Pressure feature is intended to test the pressure relief valve limits in an
NIBP monitor. A typical test routine involves pumping air into the pneumatic
system until the high pressure triggers the relief valve, which will then vent the
system to a safe pressure level.
Over Pressure parameters are not active during setup. Access the feature setup
page by swiping right from the Pressure page (Fig u re 82 ) or swiping left from the
Leakage Rate page (Fig u re 91 ), then press when ready.
The Target Pressure parameter controls the highest pressure reached during Fig u re 88
an Over Pressure test. This is generally the maximum acceptable relief
pressure for the safety valves. It can be set from 0 to 400 mmHg, in 1 mmHg increments.
The Release Time designates the amount of time allowed for the pressure relief valves to vent
system pressure to a safe level. This value is generally specified by the manufacturer of the monitor.
It can be set from 1 to 999 seconds, in 1 second increments.
Before starting an Over Pressure test, first place the NIBP monitor in
service mode or pop-off/relief pressure test mode, as appropriate. When
setup is complete, the button will intiate the test and show the
Result screen.
The button can abort the Over Pressure test at any time when
it is busy. The test can then be restarted with the button. Fig u re 89
When an Over Pressure test is started, it attempts to pump air into the
pneumatic system until the relief valves are triggered. If the A1 senses a
valve trigger, it will immediately stop pumping and allow the DUT to vent
system pressure for the duration of the Release Time .
At the conclusion of the Release Time countdown, the End Pressure will be
recorded and the tester will vent all remaining pressure and report two
measurements:
• Actual Pop Off Pressure - exact pressure that caused valve trigger
• End Pressure - system pressure at the expiration of Release Time
If the test does not sense a valve trigger before reaching Target Pressure ,
then it will instead report the Actual Pop Off Pressure as “Not tripped”, and Fig u re 90
the End Pressure will remain blank.
A Leakage Rate test assesses the rate at which air leaks from a pneumatic system,
typically by inflating up to and then holding a certain pressure for a predetermined
amount of time.
Leakage Rate parameters are not active during setup. Access the feature setup page
by swiping left from the NIBP Simulation page (Fig u re 76 ) or swiping right from
the Over Pressure page (Fig u re 88 ), then press when ready.
4.7.5.1 Mode
The Start Pressure parameter sets the initial pressure for the Leakage Rate test in Auto M ode . It
can be set from 20 to 400 mmHg, in 1 mmHg increments. This setting has no effect in M anual
M ode .
Test Time determines how long the Leakage Rate test will try to hold the
Start Pressure in the pneumatic system without active regulation. It can be
set from 30 to 600 seconds, in 1 second increments.
Before starting an Over Pressure test, first place the NIBP monitor in
service mode or manual valve control/leak test mode, as appropriate. When
setup is complete, users can initiate a test in the selected M ode and show the
Result screen with the button.
The button can abort the Leakage Rate test at any time. The test can then be restarted
with the button on the setup page.
At the beginning of an Auto M ode test, the A1 will begin pumping air into the pneumatic system
until pressure reaches Start Pressure . The Test Time countdown will automatically start after the
target pressure is reached.
In M anual M ode , any incoming pressure must be from an external source (i.e., from the NIBP
monitor itself, or alternatively from a hand pump). When pressure reaches the desired level, then
users can start the Test Time countdown by pressing the button on the Result screen
For both M odes , the button is initially disabled; however, users can assign i
example, it becomes clear that a system leak is too large to reach Start Pressure . Otherwise, the
PASS result will be available at the conclusion of the test.
When Test Time expires, the A1 measures the pressure one last time, then
vents the pneumatic system. The test will then calculate and display the
Leakage Rate in mmHg per minute.
Fig u re 93
The Timer/Stopw atch can be accessed by touching the TOOL tab on the left side of the vPad-A1 M ain
screen (Fig u re 17).
A Timer/Stopw atch can be added to an AutoSequence by creating an AutoSetting with a specific Time and
M ode .
The Settings menu includes features which enable users to optimize performance of vPad-A1. It is
accessible by touching the button on the A1 M ain screen (Fig u re 17 ).
Each of the three simulation modules are capable of entering Standby M ode
in order to conserve power and extend battery life. While in Standby M ode ,
module hardware will not generate any simulation or performance test
signals.
If the A1 App detects that a module has been idle for some time, it will
automatically set that module to Standby M ode . Each module will re-enter
Simulate M ode if the user launches its setup interface from the tabbed Fig u re 94
toolbar on the M ain screen:
To manually toggle a simulation module’s power mode, simply use the radio buttons inside the
“Power Management” section of the Settings panel. Changing the power mode also sets the default
state of each module on App startup. New configurations will be applied immediately, but they will
not persist upon quitting the App unless the button is pressed.
The Sleep After setting controls the length of time after a setup menu is dismissed before the
corresponding simulation module is considered “idle” and is then placed on standby.
• USB (to A1 base) - for wired USB connection with the vPad-A1 Base module
- follow instructions in ?
• USB (to ES) - for wired connection with the vPad-ES Safety Analyzer
- for remote operation via the vPad-Check™ app
No te : Two USB options exist for compatibility with both the A1 Tablet and remote
control through the vPad-ES Safety Analyser (using vPad-Check). Contact
Datre n d Cu s to m e r Su p p o rt for more information.
To manually change the A1 Communication interface, simply use the radio buttons under
“Operation Mode”. Changing the operation mode also sets the default connection method on App
startup. New configurations will be applied immediately, but they will not persist upon quitting the
App unless the button is pressed.
When the App is first launched, it attempts to make a connection according to the last saved
Communication settings. Changing the “Operation Mode” will break the current connection and
cause the App to make another connection with the new settings.
The Bluetooth Device setting specifies the Bluetooth name of the target to connect with, which can
be either an A1 Base or a vPad-ES Safety Analyser. A dropdown menu lists all Bluetooth devices
currently paired with the Tablet ; only names that begin with “DSI-VPAD” are valid targets.
In a typical pulse oximeter, the SpO2 R-Curve is the means by which that
particular device translates its measurement of light transmission through
oxygenated blood to an oxygen saturation in percent. Individual R-Curves
are derived through clinical studies and, while similar, may be different for
each make and model encountered. vPad-A1 has R-Curves pre-
programmed for a number of common monitor makes and models;
however, users may need to add a new device to the make/model menus.
Users can enter new information into the three text input boxes as
appropriate for the new device. Alternatively, press the Folder Search
icon to choose an existing R-Curve as template. A new window will show a
folder list of known M anufacturers , as in Fig u re 97.
Touching any M anufacturer folder will populate the M odels dropdown menu
with existing devices in the same category. Once the desired M odel is chosen
from the list, users can confirm the selection by pressing .
• When the pulse oximeter sensor is placed on the vPad-O2 finger, the
Signal Strength indicator will display the output of the oximeter's
Fig u re 98 sensor in real time.
• With Signal Strength at the ideal level, the oximeter device should
begin making SpO2 readings. If the readings do not settle onto a
Fig u re 100 constant SpO2 percentage, adjusting the Optical Density may improve
performance. Density 2 is the default which is suitable for many
devices.
Fig u re 101
• Adjust the R/IR Ratio until oximeter reading agrees with the calibration
point SpO2% .
• Perform ratio adjustment for each calibration point on the SpO2% list.
• Some pulse oximeters are not specified for measurement of low values
of SpO2% (i.e. less than 70%). If the oximeter is unable make a good,
stable reading of the saturation level, tick the checkbox to mark
the corresponding calibration point as invalid.
• The button will save the entered R-Curve data to a new or existing device entr
as identified by the M anufacturer, M odel, and (optional) Sensor fields on the menu.
No te : The special NIBP Simulation setup interface does not allow navigation to other NIBP
features such as Pressure and Leakage Rate via the swipe gesture.
Each NIBP Simulation corresponds to an Envelope that is specifically customized for the chosen
Device . The Envelope contains parameters that allow the vPad-BP simulator unit to generate
precise pressure pulses during the course of a simulation test.
The calibrated data points in an NIBP Envelope are also inflection points
where a “corner” changes the normally linear relationship between pressure
and amplitude, as shown in Fig u re 103. From left to right, the names of the Fig u re 103
calibrated inflection points are:
PML PMH
Dia. Sys.
P-Low P-Hi
Each time a change is made to an Envelope inflection point, users must press button for
the new parameters to take effect.
• PMH + PML: Adjust these pressures (x positions) to achieve a target MAP reading.
Some devices require both points to coincide at the desired MAP in a sharp
peak.
Other devices perform better when the points form a plateau near MAP,
with one or both points offset from the target reading.
• Sys. + Dia.: Adjust these pressures (x positions) so that they correspond to the target
SYS and DIA readings, respectively.
• P-Hi + P-Low: Different devices can have vastly different "ideal" Envelope shapes that
conform best to their algorithms.
To select an inflection point for editing, simply press a button in Fig u re 104
to highlight it on the graph. For all selected points (except for PMH and
PML), a brief description above the graph shows the current pressure (x
position) measured in mmHg, and amplitude (y position) as a percentage of
the maximum pulse height.
PMH and PML are always at 100% peak, so their amplitudes are not shown
and their amplitude adjustment buttons will be disabled. Instead, the
description shows the pressure of both PMH and PML at once, as well as
the mid-point (mean) and pressure difference (delta) between them.
Fig u re 104
The Shift controls move the entire Envelope horizontally along the pressure axis. Pressing a or
button moves all inflection points by the same pressure shift. The default increment is 10
mmHg of pressure, though users can enter any custom number from 0 to 50 in the input box.
Changes to the Shift increment will only be applied after pressing the "Done" button on the
keyboard.
Pressing the button in Fig u re 103 dismisses the tool and returns to NIBP simulation
settings after warning users of unsaved changes.
After users have verified via the button that the displayed
Envelope produces the expected readings on the target device, the
button will launch a “Save Envelope” form.
Pressing in Fig u re 106 saves all displayed pressure parameters to an Envelope file. If
none of the fields in the form were edited, then the originally chosen template will be overwritten.
After saving or when the button in Fig u re 106 is pressed, the interface returns to the
“Customize Envelope” screen in Fig u re 103 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.
The NIBP Self Test Tool shown in Fig u re 107 checks the height of
standardized test pulses. All vPad-BP simulators are calibrated
before leaving factory to ensure that each pressure pulse generator
can accurately produce the same range of pulse amplitudes during an
NIBP Simulation . However, with its mechanical components under
heavy use or simply over a period of time, the generator’s
performance may in some cases drift away from factory conditions.
Fig u re 107
• Setting up the desired simulations (ECG , Respiration , SpO2 , etc.) in the A1 App
• Connecting the DUT to A1 module(s) using signal leads, cables, hoses and adapters
After generating a series of Test Results for the same DUT , the A1 can consolidate them into an equipment
Test Record that documents in detail the conditions and outcomes of the tests performed. Furthermore,
these Test Records can be integrated with another Equipment M anagement System , depending on
institutional or regulatory requirements.
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 M ain screen. The Sync M ode feature
ensures that all heart signals are triggered simultaneously and share a common Heart Rate . Outside of Sync
M ode , patient parameters may appear incorrectly timed on monitor displays with multiple traces.
Heart beat triggers are generated whenever a patient ECG W aveform is active. Therefore, the vPad-PS
module must be present in the system to make use of Sync M ode , and it must be set to simulate one of the
following:
When Sync M ode is active, the shared Heart Rate setting can be managed from the ECG setup screen.
Controls for Heart Rate on all other modules will be disabled.
When running an AutoSequence in Sync M ode , the ECG Heart Rate will override all other modules in the
same AutoSequence Group . The A1 will display a warning if no ECG AutoSetting was added in the
AutoSequence to drive the synchronized heart beat.
When the simulation test setup is complete, whether through manual input (as described in chapter 4 -
O p e ratio n : Sim u latio n Mo d u le s ) or an AutoSetting or AutoSequence (section 5.2 - T e s t Au to m atio n ),
users can record the values observed on the Device Under Test (DUT ). A custom Test Result interface can
be accessed with either the button or the button.
When displayed, the Result screen will be specific to the type of simulation currently in use. It will
display all the settings and options that are active in the simulation. If there is a physiological
parameter that may be represented as a number on the DUT , an editable blue button allows a user to
enter that value as shown by the DUT . By default, on entering the Result screen such buttons are
initialized with corresponding settings from the A1 simulation in use.
Once data and observation input is complete, users can create a temporary Test Result entry by
pressing the or button. The choice depends on limits from user test proced
Drag the displayed results up and down to scroll through additional pages as more Test Result
entries are appended to the bottom of the record. Pressing the “Clear Last” button erases the most
recent entry, whereas pressing “Clear All” removes all entries from the report to enable the start of a
new test session.
No te : The “Clear Last” and “Clear All” actions cannot be reversed. If the “View Results”
screen is from completing or terminating an AutoSequence , the options to clear the
last entry or all entries will not be available unless the View Results screen is closed
and then re-entered.
As Equipment Information is saved, A1 develops an internal equipment database for later reference
so as to avoid re-entering the same data in the future for the same device. There is also the
possibility of pre-loading an equipment list as exported from, for instance, a CMMS system; contact
Datrend for further details.
Entered text can be a complete or partial match for the equipment under
test. If the search is successful, then the lookup window will show a list of
matches as in Fig u re 113.
Fig u re 113
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 Search box in the lookup
window (or leave it blank) and then press the button.
No te : The Equipment Information form does not retain any text entered upon exit.
At this point, users can override the Overall Test Result from “PASS” to
“FAIL” and, optionally, enter reasons in the Comments box. Only a
“PASS” result can be overridden; a record with one or more failed tests will
always report the Overall Test Result as “FAIL”, which cannot be changed.
Users may also enter the Labor Time and edit the default Test Report Title ,
if necessary. In the final Test Report , the combined total Labor Time (hours
+ minutes) will be entered as decimal hours (e.g. 1 hr 30 mins º 1.5 hrs) to Fig u re 118
support CMMS system requirements.
The button will discard the entered Equipment Information and exit the Test Reco
creation interface. This will not undo changes made to the equipment database. To temporarily
dismiss the Test Record creation interface while retaining the saved Equipment Information , use the
Back button instead.
Finally, pressing the button will save the Test Record file to Tablet memo
which can later be recalled and viewed in the vPad-Record Manager App. The operation will also
clear all current Test Results from the View Results screen.
vPad Record M anager is an app which is installed on the Tablet and which may be run
independently of the vPad-A1 app.
Record M anager may be used to copy, print, and/or delete Test Record files saved by vPad-A1.
Record M anager can also be used to convert Test Records to Adobe PDF documents.
Press the icon on the Home screen to launch the Record M anger app.
Refer to MN-087 6100-081 v Pad -RM O p e rato rs Man u al for further information on use of the
Record M anager .
5.2.1 AutoSettings
vPad-A1 is designed to work in both manual and automated mode. For any given type of simulation (e.g.
ECG Normal Sinus Rhythm ) there are a number of parameter values that define the simulated state (e.g.
Heart Rate , Amplitude , Artifact , M ode , and Axis ). In manual operation, every parameter can be modified
individually to create a particular test condition as detailed in chapter 4 - O p e ratio n : Sim u latio n Mo d u le s ,
and the resulting response from the DUT can be recorded in a single Test Result .
Alternatively, it may be desirable to make modifications to all parameters at once before recording a new
DUT response. This can be accomplished efficiently using module-based AutoSettings , in which all changes
to settings are made and then saved as a named simulation state.
Fig u re 121
When the Results button is pressed, the Instructions (if any) will be shown
on the screen. If you wish to enter any comments for the measurement being
recorded, select Comments and touch inside the white text window.
Fig u re 122
To delete an AutoSetting , press the icon after it is selected, then use the but
5.2.2 AutoSequences
An AutoSequence is a pre-defined series of simulation or performance tests. These tests may involve only
one parameter or multiple A1 simulation modules acting in unison.
Each step of an AutoSequence is called a Group , which consists of one or more AutoSettings pulled from
various simulation modules (see 5.2.1 - Au to Se ttin g s ). For instance, a particular AutoSequence Group may
define an ECG state (W aveform , Heart Rate , Amplitude , etc.) as well as a Dynamic IBP waveform and a
saved NIBP Simulation , all at the same time. The Group applies these definitions concurrently, as if they
have been simultaneously recalled through their respective AutoSettings menus.
Each AutoSetting will correspond to a single Test Result entry. Users can assign a “PASS” or “FAIL”,
depending on the response of the DUT , or else bypass that prompt to record a “SKIP”. After generating a
Test Result for every AutoSetting , the A1 will proceed to the next step and repeat as necessary.
Following application start-up, vPad-A1 will display the AutoSequence dropdown menu on its M ain
screen.
Fig u re 123
Touching the selection box will display the list of available AutoSequences.
Fig u re 124
Fig u re 125
Fig u re 126
The Test Result interface displays all active parameter settings for ECG so that users can view them
as reference to check the DUT ’s performance. Refer to section 5.1.2.1 - Cre atin g T e s t Re s u lts for
further details on working with the Result interface.
Assigning a “PASS” or “FAIL” will dismiss the current Result interface and summon the next
Result in the Group. Users can also record a “SKIP” for this instance by pressing .
Fig u re 127
After an AutoSequence has been selected from the list, its name will be displayed in the menu box
and the Run button will be enabled (turned from gray to green). At this point this AutoSequence is
available for editing.
Fig u re 130
The larger toolbar may be displayed by pressing either of the
buttons at bottom left and right on the screen.
Fig u re 129
Starting at the top of the screen, the AutoSettings are organized by their corresponding A1
simulator modules.
Fig u re 132
The centre section of the Editor menu is for displaying and editing
AutoSequence Groups . The name of the current AutoSequence
filename will be shown here, along with a list of the Groups of
concurrent AutoSettings contained within the AutoSequence .
A Group or AutoSetting entry is considered active when its name is Fig u re 133
highlighted in yellow. Activate any entry by touching its name bar.
Icon Action
Move the active AutoSetting entry up one in the list.
When working with the Groups viewer and Action Controls , note the following:
• If users enter the Editor without an active AutoSequence selected, the Groups list will be
empty. A user must then add at least a single Group before adding AutoSettings .
• A Group can contain only one AutoSetting from each parameters category. To replace an
AutoSetting with another of the same type, first remove the original AutoSetting before
adding the new selection.
• The order of AutoSettings in a Group will only affect the sequence of appearance for each
corresponding Test Result interface. AutoSettings in a Group are always applied in close
succession before prompting for their Results .
• Default Group names can be changed by pressing and holding the Group name bar until an
input box appears.
Changes made in the Editor will not persist if users do not save the file. Saving an AutoSequence
without changing the pre-populated file name will overwrite the selected template.
When AutoSequence editing is complete, return to the A1 M ain screen by touching the Back
button by swiping left on the Editor screen.
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 run statement.
For calibration or service assistance, contact Datrend for a Return Materials Authorization (RMA) number
and the location of the nearest Service Facility.
vPad-A1 may be cleaned with a soft, lint free, damp cloth using a mild detergent. Use of other cleaning
agents on the touchscreen may result in scratching, discolouration, streaking or even failure.
* reference to vPad-A1 includes the Base, tablet, vPad-PS, vPad-O2 and/or vPad-BP module(s)
Maintenance/Chapter 6 # Page 87
vPad-A1 OPERATORS MANUAL
Maintenance/Chapter 6 # Page 88
vPad-A1 OPERATORS MANUAL
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.
No te : The sample Test Record was generated in Demo M ode . Hence, all unit identifiers under
vPad ID contain the word “DEMO”. A normal record will contain real vPad IDs matching
the serial number decals on each Simulator/Tester Unit, along with the date of the latest
calibration.
Appendix A # Page 89
vPad-A1 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: CARDIAC CARE UNIT
Facility: CITY GENERAL
Technician ID: RW
Tech Time (hrs): 0.6
(min): 35
Signature:____________________________ Date:__________
_______________________________________________________
END OF RECORD
Appendix A # Page 90
vPad-A1 OPERATORS MANUAL
Appendix A # Page 91