Infutest Solo
Infusion Pump Analyzer
Operating Manual
Infutest Solo
Infusion Pump Analyzer
Operating Manual
© 2004-2014 Datrend Systems Inc.
#130 - 4020 Viking Way
Richmond, BC • CANADA. • V6V 2L4
Tel 604.291.7747 or 800.667.6557 • Fax 604.294.2355
e-mail customerservice@datrend.com
To order this manual, use Part Number 6100-400
Revision
Revision History
Description
Date
E
Clarify Warranty
Update Address
2012-Aug-30
F
Update max flow rate.
Change Corporate Address.
2014-May-13
Copyright
Datrend Systems Inc. (“Datrend”) agrees to a limited copyright release that allows you to reproduce manuals and
other printed materials for use in service training programs and other technical publications. If you would like other
reproductions or distributions, submit a written request to Datrend.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If
damage is found, stop unpacking the instrument. Notify the freight carrier and ask for an agent to be present while
the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the
instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or
scratches.
Claims
Our routine method of shipment is via common carrier. Upon delivery, if physical damage is found, retain all packing
materials in their original condition and contact the carrier immediately to file a claim.
If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any
other problems not caused by shipping damage, please contact your local sales representative or Datrend
immediately.
Standard Terms and Conditions
Refunds & Credits
Please note only serialized products (products labelled with a distinct serial number) and accessories are eligible for
partial refund and/or credit. Non-serialized parts and accessory items (cables, carrying cases, auxiliary modules,
etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been
damaged, and must be returned complete (meaning all manuals, cables, accessories, etc.) within 90 days of original
purchase and in “as new” and resalable condition. The Return Procedure must be followed.
Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number,
obtained from Datrend Customer Service. All items being returned must 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 minimum restocking fee of 15%. Products
returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20%.
Additional charges for damage and/or missing 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 customer at
their expense.
Certification
This instrument was thoroughly tested and inspected and found to meet Datrend's manufacturing specifications
when it was shipped from the factory. Calibration measurements 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 measured against in-house performance standards using accepted test
procedures.
Page i
Warranty
Warranty and Product Support
Datrend Systems Inc. ("DSI") warrants this instrument to be free from defects in materials and workmanship under
normal use and service for one (1) year from the date of original purchase. This warranty will be automatically
extended on a yearly basis, to a maximum of five (5) years from the date of original purchase, provided that
calibration is performed 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 materials and workmanship at no charge; provided the 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 damage from abuse, neglect, accident or misuse or as the result of service or
modification by other than DSI. IN NO EVENT SHALL DATREND SYSTEMS INC. BE LIABLE FOR
CONSEQUENTIAL DAMAGES.
This warranty is subject to the following limitations:
! Occluder Valve: 1 year limited warranty
! Pressure Transducer: 1 year limited warranty
! Battery Pack: 1 year limited warranty
! Standard Accessories: 90 day limited warranty
! Re-calibration of the instrument, which has a recommended annual calibration frequency, is not covered under the
warranty.
No warranty shall apply when damage is caused by any of the following:
! Introduction of fluids not specified in the instruction manual,
! Application of excessive pressure or vacuum/suction to the device inputs,
! Failure to rinse or clear the fluid flow path as instructed in the manual,
! Power failure, surges, or spikes,
! Damage in transit or when moving the instrument,
! Improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or misuse of the instrument,
! Fire, water damage, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.
Only serialized products (those items bearing a distinct serial number tag) and their accessory items are covered
under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE WARRANTY. Items such as cables and non-serialized modules are not covered under this warranty.
This warranty gives you specific legal rights and you may have other rights, which vary from province to province,
state to state, or country to country. This warranty is limited to repairing the instrument to DSI's specifications.
When you return an instrument to DSI for service, repair or calibration, we recommend shipment using the original
shipping foam and container. If the original packing materials are not available, we recommend 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 instrument surfaces. Use nonabrasive material around all projecting
parts.
! Use at least four inches of tightly packed, industrial-approved, shock-absorbent material all around the instrument.
DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper
packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and
taxes). No returns will be accepted without a Return Materials Authorization ("RMA) number. Please contact
Datrend (see Appendix C) to obtain an RMA number and receive help with shipping/customs documentation.
Page ii
Warranty Disclaimer
Should you elect to have your instrument serviced and/or calibrated by someone other than Datrend Systems,
please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality
Seal is removed or broken without proper factory authorization. We strongly recommend, therefore, that you send
your instrument to Datrend Systems for service and calibration, especially during the original warranty period.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as this seal is the key to your
original instrument warranty. In the event that the seal must be broken to gain internal access to the instrument (e.g.,
in the case of a customer-installed firmware upgrade), you must first contact Datrend Systems (see Appendix C).
You will be required to provide us with the serial number for your instrument 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 instrument without interruption.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock
hazards or improper operation. Datrend will not be responsible for any injuries sustained due to unauthorized
equipment modifications.
DATREND DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.
THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.
UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID
THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES.
Windows 95, Windows 98, Windows 2000, Windows XP, and Visual Basic are trademarks or registered trademarks of
Microsoft Corp.
Fluke® is a registered trademark of Fluke Corporation
Jet Dry® is a registered trademark of Reckitt Benckiser plc
Page iii
Page iv
INFUTEST SOLO OPERATING MANUAL
Table of Contents
1. SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 Flow Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Occlusion Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Auto Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 Non-Volatile Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
1
1
2
2
2
4
2. OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Controls and Interface Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3 Test Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
5
6
8
3. SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 Fluid and Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Optional Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.1. RS-232 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.2. USB Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Installing DTP Solo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.5 Setting Up a HyperTerminal Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
11
13
16
16
18
18
20
4. OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Power-On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.1. Keypad Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.2. Barcode Reader Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Test Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.1. Rate+Volume Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.2. Occlusion Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.3. Auto Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4 Test Execution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.1. Setting Up and Running a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.2. Starting a Pressure Test from a Running Flow Test . . . . . . . . . . . . . . .
4.4.3. Monitoring a Test in Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.4. Stopping a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.5. Viewing a Test Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4.6. Saving Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Option Menu Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.1. Viewing Test Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.2. Delete a Single Test Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.3. Transferring a Single Test Record to a PC/Printer . . . . . . . . . . . . . . . .
23
23
24
24
26
27
27
27
28
29
30
31
31
32
32
33
34
35
35
36
Table of Contents # Page v
INFUTEST SOLO OPERATING MANUAL
4.5.4. Transferring Multiple Test Records to a PC/Printer . . . . . . . . . . . . . . . .
4.5.5. Erasing Memory Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.6. Packing Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.7. Setting the Real-Time (RT) Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.8. Selecting Pressure Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.9. Configuring the Auto Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.10. Editing the Solo ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.11. Checking the Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6 Recharging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
38
40
40
41
42
42
43
44
44
5. REMOTE CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2 Command Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.1. Run Flow Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.2. Run Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.3. Stop Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.4. Get Flow Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.5. Get Pressure Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.6. Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
45
45
46
46
46
47
47
48
48
6. ERROR & WARNING MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1 Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2 Dead Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3 Flow Sensor Unprimed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4 Calibration Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5 Pressure Zero Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6 Port Off-line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7 Download Application Not Running . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8 Memory Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.9 Injection Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.10Over-Pressure Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
51
51
52
52
53
53
54
54
55
55
56
APPENDIX A.
BACK PRESSURE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
APPENDIX B. OPERATIONAL OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
B.1 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
B.2 Flow Measurement System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
B.3 Pressure Measurement System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
59
59
60
61
APPENDIX C. CALIBRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C.1 Annual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C.2 Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C.2.1 Pressure Accuracy Verification - Field Test . . . . . . . . . . . . . . . . . . . . . .
C.2.2 Flow Accuracy Verification - Field Test . . . . . . . . . . . . . . . . . . . . . . . . .
63
63
64
64
64
Table of Contents # Page vi
INFUTEST SOLO OPERATING MANUAL
Specifications
This chapter provides performance specifications for the
Solo Infusion Device Analyzer.
1. SPECIFICATIONS
1.1 Flow Test
I.
II.
Flow Measurement
a.
Range:
b.
Resolution:
c.
Accuracy:
Volume Measurement:
a.
Range:
b.
Resolution:
c.
Accuracy:
III. Elapsed Time Measurement:
a.
Range:
b.
Resolution:
c.
Accuracy:
d.
Format:
1 - 1200 ml/hr
0.001 to 1 ml, depending on rate
± 1% of reading
0 - 9999 ml
0.001 ml to 1 ml, depending on volume
± 1% of reading
0 - 100 hours
1 second
+0, -1 second
HH:MM:SS (hours, minutes, seconds)
1.2 Occlusion Pressure Test
I.
Pressure Measurement:
a.
Range:
b.
Resolution:
c.
Accuracy:
Specifications/Chapter 1 # Page 1
0 - 2586 mmHg (0 - 50 psi)
1 mmHg
± 1% of reading, ± 5 mmHg
INFUTEST SOLO OPERATING MANUAL
II.
Elapsed Time Measurement:
a.
Range:
b.
Resolution:
c.
Accuracy:
d.
Format:
0 - 100 minutes
1 second
+0, -1 second
MM:SS (minutes, seconds)
1.3 Auto Test
I.
II.
Infusion Timer
a.
Range:
b.
Resolution:
c.
Accuracy:
0 - 9999 seconds
1 second
+0, -1 second
Occlusion Timer
a.
Presets:
b.
Accuracy:
OFF, 1, 2, 3, 5, 10, 20 min
+0, -1 second
1.4 Non-Volatile Memory
I.
Capacity:
123 Test Records
II.
Record Content:
Pump ID (Control Number)
Test Date (DD MMM YYYY)
Test Time (HH:MM)
Average Rate (ml/h)
Infused Volume (ml)
Peak Occlusion Pressure (mmHg, psi, kpa, bar)
Time of Peak Pressure (MM:SS)
1.5 Interface
I.
User Interface:
20-character by 2-line LCD
12-button membrane-type keypad
LCD contrast control
Specifications/Chapter 1 # Page 2
INFUTEST SOLO OPERATING MANUAL
II.
Fluid interface
a.
Input:
b.
Output:
Delrin twistlock, self-sealing
Delrin twistlock
III. USB Port
a.
Connector:
b.
Protocol:
c.
Data Rate:
Type “B”
USB 1.1 or USB 2.0 compatible
64 bytes per millisecond
IV. RS-232 Port
a.
Connector:
b.
Protocol:
V.
DB9 male
RS-232C; bidirectional; CTS handshaking;
9600 baud, 8 data bits, no parity bit, 1 stop bit
Power Supply:
Internal 12V NiMH, operation time (approx) 30 hours.
VI. Charger:
Universal 100-240 VAC to 18VDC c/w adapter clip
Adapter clips available for North America, Europe, UK, Australia, and China
VII. Environment:
15EC to 40EC
10% to 80% RH
Indoor Use Only
Category I
Pollution Degree 2
Altitude <2000m
VIII. Dimensions:
8.5" W x 6" D x 10" H
22 cm W x 15 cm D x 26 cm H
IX. Weight:
Unit and AC Adapter
Specifications/Chapter 1 # Page 3
5.0 lbs.
2.3 kg
INFUTEST SOLO OPERATING MANUAL
1.6 Accessories
I.
Standard Accessories:
Universal AC Adapter, P/N 3000-400
Adapter Blades for AC Adapter:
- North America, P/N 3000-401, or
- Europe, P/N 3000-402, or
- UK, P/N 3000-403, or
- Australia / China, P/N 3000-404
Input/Output tubing set, P/N 7300-012
Flushing syringe (60cc), P/N 7006-006
USB cable (A-B Male), P/N 3140-403
Data Transfer Program (DTP Solo) for Windows 98/2000/XP, on
CD-ROM P/N 6950-002
II.
Optional Accessories:
Operating Manual, P/N 6100-400
Computer interface cable (RS-232), DB9F - DB9F, P/N 3140-400
Computer interface adapter (RS-232), DB9M - DB25F, P/N 3140-401
Printer interface adapter, DB9M - DB25M, P/N 3140-402
Citizen iDP-3110 serial printer, P/N 7050-055
Barcode Pen Reader, P/N 7050-050
Barcode CCD Scanner (RS-232), P/N 7600-051
Barcode CCD Scanner (PS2), P/N 7600-052
Specifications/Chapter 1 # Page 4
INFUTEST SOLO OPERATING MANUAL
Overview
This chapter gives an overview of the capabilities of Solo, the tests
performed and test fluid requirements.
2. OVERVIEW
2.1 General Description
The Infutest Solo Infusion Device Analyzer (“Solo”) is a portable, automated system for
performing flow rate, effused volume and occlusion pressure tests on volumetric medical
infusion devices.
Solo provides three test modes for evaluating volumetric accuracy and the occlusion
pressure limit of an infusion device. The first test mode uses an internal flow sensor to
measure average flow rates in the range 1 ml/hr - 1200 ml/hr, and effused volume to
9999 ml. The second test mode blocks the output of the infusion device and uses an
internal pressure sensor to measure the maximum pressure generated by the device
under test when its output is occluded. The third test mode is automated and will
perform a flow test followed by an optional occlusion pressure test, each test having a
duration preset by the user.
Upon completion of a test, Solo generates a test result summary that may be saved in the
instrument’s non-volatile memory. Saved records may then be viewed directly on the
Solo LCD, transferred to a PC, or sent to a printer. The non-volatile memory also allows
Solo to be disconnected from AC power and transported without losing previously
acquired test results.
Solo may be powered from its internal NiMH battery or from AC power using the
accessory power adapter provided with the unit. The internal battery has sufficient
capacity to provide approximately 30 hours of continuous operation.
Overview/Chapter 2 # Page 5
INFUTEST SOLO OPERATING MANUAL
Solo has two communication ports; RS-232 and USB. The RS-232 Port may be
connected to a personal computer, accessory barcode reader, serial printer, or automated
test system while the USB Port is intended solely for rapid data transfer to a personal
computer using the accessory software application, DTP Solo.
To accommodate long-term testing or special testing needs, Solo may also be remotely
controlled via its RS-232 Port. The remote control command set allows Solo to be
controlled by a personal computer or other device providing an RS-232 interface.
2.2 Controls and Interface Connections
Figure 1 illustrates the user controls and interfaces of Solo. The fluid and electrical
interfaces are described in Section 3 of this manual. Keypad operation of Solo is
described in Section 4.2
Overview/Chapter 2 # Page 6
INFUTEST SOLO OPERATING MANUAL
Figure 1: Controls and Interfaces
â
ã
ä
å
æ
2 x 20 Liquid Crystal Display (LCD)
12-Button Keypad
RS-232 Port
LCD Contrast Control
USB Port
ç
è
é
ê
ë
Overview/Chapter 2 # Page 7
Fluid Input
Fluid Output
Power ON/OFF Switch
DC Power Input
Carrying Handle
INFUTEST SOLO OPERATING MANUAL
2.3 Test Fluids
The following test fluids are acceptable for use with Solo:
1.
DISTILLED WATER
2.
CLEAN DOMESTIC WATER (i.e. "tap water")
Common distilled water is the preferred test fluid. If domestic water is used, occasional
flushing with distilled water may be required following use, depending on the hardness
and quality of the local water. The test fluid should be colourless and should not contain
visible particulate matter. An agent for reducing surface tension of the test fluid is not
normally required for routine use. However, a wetting agent such as Jet Dry (for
dishwashers) may be added if required. In the case of Jet Dry, a concentration of 1.0 ml
per litre of test fluid is recommended as a starting point. Wetting agent concentration
may have to be varied depending the purity of the test fluid.
IMPORTANT:
THE USE OF SALINE SOLUTION AS A TEST FLUID IS STRONGLY
DISCOURAGED, AND WILL VOID THE WARRANTY. IN THE EVENT
SALINE SOLUTION IS ACCIDENTALLY USED, Solo SHOULD BE
FLUSHED WITH DISTILLED WATER.
DO NOT USE DEXTROSE IN WATER (eg. D5W, D25W) OR OTHER
VISCOUS TEST FLUIDS WITH Solo. USE OF SUCH FLUIDS WILL VOID
THE WARRANTY.
If Solo is in daily use, the fluid channel should be kept primed between tests,
provided distilled water or low hardness domestic water is used. If Solo is to be stored
for several months or transported, fluid should be drained from the unit by forcing air
into the fluid channel input with a large syringe. Solo should then be carefully blown out
from the input to the output using clean, dry compressed air.
For the remainder of this manual, the test fluid is assumed to be distilled water or lowhardness domestic water, and is referred to generically as "water".
Overview/Chapter 2 # Page 8
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IMPORTANT:
IV sets which have or may have come in contact with saline or dextrose or
other IV fluids should not be used on Solo. If an IV set must be re-used
(i.e. as part of an incident investigation), ensure the set has been flushed
out thoroughly with clean water before connecting the set to Solo. Most IV
fluids contain salts and sugars which can degrade and potentially ruin the
high-precision flow sensor inside Solo.
It is always best to use a new administration set when testing a pump.
However, the same administration set may be re-used to test several
pumps provided the set is primed only with distilled or “sterile” water.
Change IV sets per the manufacturer’s recommendations to ensure that
test results reflect clinical use of the infusion device.
2.4 Cleaning
The following cleaning procedure should be performed on Solo once a month if the
instrument is used with tap water, or once every three months if Solo is used exclusively
with distilled water. These recommendations apply to instruments which remain set up
and primed at all times. If Solo spends most of the time dry and in storage, cleaning
should be conducted more frequently, ideally when the dry instrument is first primed
during setup. Cleaning after a period of dry storage is the preferred method of "wetting"
the fluid system prior to use (see Section 3.2).
In the event of accidental contamination with dextrose or TPN solution, the following
procedure should be adequate, provided cleaning is performed immediately following
contamination. If cleaning does not appear to improve test results (i.e. flow
measurements are persistently erratic, low or nonexistent), contact Datrend Customer
Service at 1-800-667-6557 (604-291-7747 outside of North America).
a.
Make 200 ml of cleaning solution by mixing 100 ml of distilled water with
100 ml of "Sudsy Ammonia" household cleaner (e.g. AMEX brand by
Colgate-Palmolive Inc.). If “Sudsy Ammonia” is not available in your area,
add one-half teaspoon of liquid dish soap ( NOT automatic dishwasher
detergent!) to the 200 ml of ammonia and water solution.
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b.
Fill a disposable 60 ml syringe with the cleaning solution and connect the
syringe to the fluid input. Don't use the same syringe you use to prime Solo
because the cleaning solution will remove the syringe's lubricant.
c.
Discharge the entire syringe into Solo at about 2 ml per second. Refill the
syringe and then repeat. Under no circumstances should you quickly draw
solution back into the syringe as the excessive suction may damage Solo’s
pressure sensor.
d.
Let the cleaning solution sit in Solo for 10 to 15 minutes. DO NOT leave
the cleaning solution in Solo any longer than 15 minutes as prolonged
exposure to the solution may damage the neoprene seals of the internal
valves.
e.
Rinse the fluid channel thoroughly with distilled water to remove all
ammonia from the fluid system as described in paragraph “c” above.
f.
If the fluid system has been contaminated with a sticky liquid (e.g. D5W,
D25W, TPN solution, etc.), you may need to perform this procedure using
undiluted Sudsy Ammonia to clean the flow sensor. In this case, DO NOT
leave ammonia in Solo for more than 10 minutes, and be sure to thoroughly
rinse the instrument with distilled water afterwards as described in
paragraph “e” above.
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Set-up
This chapter describes the initial set-up of Solo, fluid priming,
RS-232/USB connections and PC software installation.
3. SET-UP
3.1 Fluid and Power Connections
Place Solo on a stable surface; or mount Solo on an IV pole using the optional IV
pole mounting bracket (Datrend P/N 7400-653). In either case, Solo MUST be
horizontally level. Insert the plug of the provided AC adapter into the rear panel
jack (see Figure 1), then plug the adapter into an AC outlet.
IMPORTANT:
YOUR Solo HAS BEEN PROVIDED WITH A UNIVERSAL AC
ADAPTER (Datrend P/N 3000-400) WHICH CAN ACCEPT AN
INPUT VOLTAGE BETWEEN 100 - 264 VAC and 50 - 60 Hz.
THE AC ADAPTER HAS BEEN SUPPLIED WITH ONE OF THE
FOLLOWING BLADE SETS PRE-INSTALLED:
North America:
Europe:
United Kingdom:
Australia / China:
P/N 3000-401
P/N 3000-402
P/N 3000-403
P/N 3000-404
USE ONLY THE AC ADAPTER PROVIDED WITH YOUR
INSTRUMENT. SUBSTITUTION OR USE OF AN ALTERNATE AC
ADAPTER MAY DAMAGE Solo AND VOID THE WARRANTY.
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a.
Connect the input tubing set (consisting of the IEC recommended 21 gauge
flow restrictor, three-way stop cock, and extension set) to the fluid input as
shown in Figure 2.
Figure 2: Input tubing connection
b.
Connect the output extension set to the fluid output as shown in Figure 3.
The fluid output should drain into a collection vessel of appropriate volume
ideally located on the bench near Solo. A small (250 to 500 ml) beaker will
suffice for most test situations.
Figure 3: Output tubing connection.
The collection vessel must NOT be located more than 36" below the
level of the fluid output. A distance greater than 36" will apply a
vacuum to Solo which could damage the internal pressure sensor, or
result in a pressure zero alarm when Solo is powered on.
If your test protocol requires the application of a Back Pressure to oppose the flow from the
infusion device under test, refer to the instructions provided in Appendix A.
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3.2 Priming
Priming Solo involves filling the internal fluid channel with water to remove all air from
the fluid pathway. Figure 4 shows the possible positions of the three-way stop cock
connected to the Solo fluid input. When the fluid channel is ON, water flows from the
infusion device under test into Solo. When the fluid channel is OFF, no fluid enters
Solo. When the fluid channel is in the PRIME/FLUSH position, fluid flows from the 60
cc syringe into Solo.
Figure 4: Stop Cock Positions
To prime a dry instrument:
a.
Rotate the stop cock to PRIME. Fill the 60 cc syringe, supplied with Solo,
with 60 cc of water. Connect the syringe to the open port on the stop cock
and discharge the syringe into the fluid channel. Rotate the stop cock to
OFF, and disconnect and refill the syringe. Repeat this priming action at
least five times. Eventually, water will begin to drain out the fluid output as
air is forced out of the fluid system and reservoir.
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b.
Prepare the device under test by loading the device with an
administration set and priming the set with water according to the
manufacturer's instructions. Connect the primed set to the stop cock and
set the stop cock to ON.
c.
If normal saline solution must be used as a test fluid (against Datrend’s
recommended practice), prime as described above. Flush the fluid channel
with distilled water immediately following the test. Under no
circumstances should the fluid channel be used or left primed with
saline for an extended period of time.
d.
Unless Solo is stored for several months at a time, leave the instrument
primed between uses. Following use, flush Solo with distilled water, set
the stop cock to OFF, and store the instrument in an upright position.
IMPORTANT:
It is best to use a new administration set when testing an infusion device, or
at least change the set periodically according to the manufacturer’s
recommendations. Use of IV sets which have or may have been used with
saline, dextrose or other IV fluids should be avoided. See Section 2.3, Test
Fluids.
IMPORTANT:
After powering-up, Solo will attempt to obtain a zero pressure reference. To
avoid a “pressure zero" alarm, ensure no pressure is applied at Solo’s input
or output when applying power to the unit. Install the IV set in the device
under test and leave the device under test on standby while Solo performs
its self-test routines, to prevent a “pressure zero” alarm.
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IMPORTANT:
When testing a syringe pump, always use a new disposable syringe.
Prelubricate the syringe by drawing on the plunger a few times before
loading the syringe with water and installing it in the pump.
After priming and connecting the administration set, always flush the fluid channel
before starting a test. Use a technique similar to that described to prime Solo by injecting
about 5 cc of water. This should be sufficient to remove any air bubbles in the fluid
channel. Solo reminds the user to flush the system via a message displayed on the LCD
prior to starting a test.
Solo may be used to test infusion devices immediately after priming the fluid channel as
described above. However, after shipping Solo, or following a period of dry storage,
optimum results are obtained if the internal flow sensor is first "wetted" before
performing tests.
Solo may be wetted by first priming the instrument, then running a Rate+Volume Test at
approximately 500 ml/hr for 10 to 15 minutes (see Section 4.4).
The preferred method of wetting, however, is to flush the instrument with a Sudsy
Ammonia solution and distilled water, following the cleaning procedure given in Section
2.4.
Wetting is optional, however, cleaning the instrument regularly is recommended,
depending on usage. For instruments in daily use with distilled or domestic water,
cleaning is recommended monthly. A thorough cleaning is essential if the instrument
becomes contaminated with fluids other than water (dextrose, saline, etc.). The
procedure for cleaning Solo is given in Section 2.4.
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3.3 Optional Connections
Solo has RS-232 and USB communication ports located on the instrument’s left panel
(Figure 1). The following sections describe the capabilities and connection
requirements for each type of serial port.
3.3.1. RS-232 Port
Solo’s RS-232 port can be used to interface to any one of the following peripheral
devices.
Personal
Computer
• Controls Solo remotely through a COM port using
the remote command instruction set.
• Downloads test result data (Test Records) stored
in Solo’s memory.
Serial
Printer
• Generates a hard copy printout of Test Records
stored in Solo’s memory.
Barcode
Reader or
Scanner
• Enables rapid entry of an equipment control
number as scanned from a barcode label on the
device under test.
Automated
Test System
• Controls Solo using the remote command
instruction set.
The multifunction RS-232 Port is realized through a DB9 male connector whose
pinout is shown in Figure 5.
Figure 5: RS-232 Port (front view)
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Accessory cables are available to connect the various peripheral devices to Solo
(Section 1.6).
Connection from Solo to a DB9 PC COM port is achieved using a DB9F to
DB9F NULL MODEM cable (Datrend P/N 3140-400).
Connection from Solo to a DB25 COM port, such as a PC or a Fluke medTester
5000, is achieved using a NULL MODEM cable, noted above, in combination
with a DB9M to DB25F adapter (Datrend P/Ns 3140-400 + 3140-401)
Connection from Solo to the Citizen serial printer is achieved using a NULL
MODEM cable, noted above, in combination with a DB9M to DB25M adapter
(Datrend P/Ns 3140-400 + 3140-402)
Alternatively, cables made to the specifications listed in Table 3-1 may be used to
connect Solo to the peripheral device. Connectors specified in the table are for
the cables, and shaded cells in the table indicate no connection.
Table 3-1: RS-232 Interface Cable Specifications
Solo
(DB9 F)
PC
(DB9 F)
PC/MedTester
(DB25 F)
Serial Printer
(DB25 M)
2 - RXD
3 - TXD
2 - TXD
3 - TXD
2 - RXD
3 - RXD
3 - RXD
5 - GND
5 - GND
7 - GND
7 - GND
4 - DTR
20 - DTR
20 - DTR
9 - VCCOUT
6 - BUSY
IMPORTANT:
NEVER CONNECT THE BARCODE READER TO Solo IF THE
POWER IS ON! THE BARCODE READER IS POWERED FROM
Solo AND MAY BE DAMAGED IF “HOT-PLUGGED”. ALWAYS
TURN Solo OFF BEFORE CONNECTING THE BARCODE
READER.
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3.3.2. USB Port
The USB Port is provided to rapidly download Test Records from Solo to a PC
using the accessory software DTP Solo. Solo may be “hot-plugged” to the PC
using a USB cable at any time while the device is running. Once DTP Solo
successfully detects Solo, test data may be sent to the PC from Solo.
A USB cable (Datrend P/N 3140-403) is provided with Solo as a standard
accessory.
3.4 Installing DTP Solo
The Data Transfer Program for Solo, or "DTP Solo", is a Windows application for
downloading Test Records stored in Solo to a PC via USB. Once the Test Records have
been transmitted to or retrieved by DTP Solo, the Records may be sorted, printed,
saved as ASCII text files, or converted to CSV (comma-separated variable) file format.
DTP Solo will run on Windows 98/2000/XP systems, and is provided with Solo on
CD-ROM. The application may also be downloaded from the Datrend Systems website
at www.datrend.com.
To install DTP Solo from the CD-ROM, insert the disc into your CD-ROM drive.
Windows should automatically launch the application Installation Wizard. Simply follow
the instructions presented by the Wizard to complete the installation. If Auto-Run is
disabled on your computer, or if you have downloaded DTP Solo from the Datrend
website, the Installation Wizard will not start up automatically. In this case, search for
the file "DTPSoloInstall.exe" on the CD or in the download directory using
Windows Explorer, or by clicking on "My Computer" on the desktop. Double-click on
DTPSoloInstall.exe to run the installer application.
When installation is complete, connect Solo to your PC using the USB cable provided
with your instrument. When Solo is connected to the PC for the first time, Windows
should detect the connection and then automatically launch the New Hardware Wizard
which will prompt you for the USB driver. The USB drivers for Solo are provided with
the DTP Solo software. When the Hardware Wizard asks for the files, direct the
Hardware Wizard to your CD drive, or to the location where the files were downloaded.
The Wizard should then find and install the required driver files.
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After installation of DTP Solo, there should be a "DTP Solo" icon on your Windows
desktop. Double-click the icon to start DTP Solo. Once the program recognizes the
attached Solo, DTP Solo will display the message shown in Figure 6 to indicate the PC
is ready to communicate with the instrument:
Figure 6
Click on “OK” to clear the “Device Attached” message. To review complete operating
instructions for the DTP Solo program, click “About” on the menu bar, then select
“Help”.
NOTE:
DTP Solo will not detect USB connection of Solo if the instrument is busy
running an Options Menu function, or is waiting for the user to input a
Pump ID at the start of a flow or pressure test.
It is always best to connect the USB Port of Solo to the PC while the LCD is
displaying the RUN TEST/OPTIONS prompt. This will ensure the
instrument is detected by DTP Solo, either before or after the program is
started.
NOTE:
During installation of the USB drivers, Windows XP users may receive a
warning message that the driver has not been "Logo Tested". Please
ignore this warning and clear the message by clicking the "OK" button
which is displayed.
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3.5 Setting Up a HyperTerminal Connection
As described in Section 3.3.1, the RS-232 Port of Solo may be connected to the serial
communications port (COM port) of a personal computer. A terminal program (i.e.,
Windows 98/2000/XP HyperTerminal or equivalent) running on the PC may then be
used to receive Test Records and save them to a text file. Follow the instructions below
to set up HyperTerminal for use with Solo.
a.
Open HyperTerminal: In Windows XP, click Start, point to All Programs,
point to Accessories, point to Communications and click on
HyperTerminal.
b.
You will be prompted to enter a name for the HyperTerminal connection
and select an icon associated with this new connection. Enter a suitable
name, select the desired icon, and click on OK. Next time, click on this
icon from Explorer or the Start menu to avoid having to set up a new
connection every time you wish to use HyperTerminal.
Figure 7
c.
A dialogue box will appear asking which port to connect to. Select the
appropriate COM port and click on OK.
d.
Another dialogue box appears to configure the port settings. Configure the
port settings as shown in Figure 8 and click on OK.
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Figure 8
e.
In the HyperTerminal program window, click on Transfer in the menu bar
and click on Capture Text to save all Test Records to a file. In the File
box, type a descriptive name for the file, and then click Start.
f.
HyperTerminal is now ready to receive data sent from Solo to the PC.
Refer to Sections 4.5.3 and 4.5.4 for details on how to transfer Test Records
from Solo to a PC.
g.
Once all Test Records have been transferred, stop capturing text. In the
Transfer menu, point to Capture Text and click on Stop.
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Operation
This chapter describes the operation of Solo, the various test modes, and
optional functions.
4. OPERATION
4.1 Power-On
Turn on Solo by switching the rear panel power switch to ON. The LCD will display a
power-up screen and Solo will perform a built-in self-test to ensure all internal
components are functioning properly. If all components pass the initial self-test, the
LCD will display the RUN TEST/OPTIONS prompt shown in Figure 9. If required,
adjust the LCD contrast control on the right panel using a trimpot adjustment tool. The
contrast adjustment is positioned between and behind the USB and RS-232 ports
(Figure 1).
RUN TEST:
OPTIONS:
<Enter>
<Options>
Figure 9
If an abnormal condition is detected during the built-in self-test, a fault message will
appear on the LCD accompanied by an alarm. Refer to Chapter 6 if an alarm condition
arises.
The RUN TEST/OPTIONS prompt is the point from which all operations begin. At
this prompt, pressing the
key on the keypad will proceed to test execution, while
pressing the
key will access the functions provided in the Options Menu.
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4.2 User Interface
Solo has a menu-driven user interface implemented with a 20-character x 2-line liquid
crystal display (LCD), and a 12-button membrane-type keypad (Figure 10). The keypad
can be used to control device operation or to enter alphanumeric data. Alternatively,
data entry is also possible using the accessory barcode reader (Datrend P/N 7050-050)
or barcode CCD scanner (Datrend P/N 7050-051).
Figure 10
4.2.1.
Keypad Operation
With the exception of the
key on the keypad, all keys have both a primary
and secondary function. The primary function of each key is written directly on
the button itself, and the secondary function is written above the button. The
primary functions are associated with instrument operation, while the secondary
functions are associated with alphanumeric data entry.
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Primary Keypad Functions:
Scrolls backward.
Scrolls backward, or increments numeric data.
Scrolls forward.
Scrolls forward, or decrements numeric data.
Selects the test mode.
Starts the selected test.
Saves test results to non-volatile memory.
Initiates an Occlusion Pressure Test.
Stops the test currently in progress.
Displays the Options Menu.
Cancels input or aborts the current operation.
Accepts the current input or selection.
Secondary Keypad Functions:
Above each key on the keypad appears a numeric digit and three alphabetic
characters for data entry purposes. When data entry is required, repeatedly
pressing a single key sequentially displays the characters associated with that key at
the current cursor position (i.e., 1, A, B, C, 1, A, B...). Pressing a key other than
the one initially pressed will enter the displayed character, move the cursor one
space to the right, and display the digit associated with the new key. Alternatively,
the displayed character is automatically entered after a 2-second inactivity timeout.
Pressing the BACKSP key clears the character displayed at the current cursor
position and moves the cursor to the left one space, providing a backspace or
correction function.
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4.2.2.
Barcode Reader Operation
An accessory Barcode Reader (Datrend P/N 7050-050) and Barcode CCD
Scanner (Datrend P/N 7600-051 or 7600-052) are available to rapidly enter
alphanumeric data from a barcode label to identify an infusion device under test
(Section 4.4.1), or to enter an ID for Solo, uniquely identifying the tester itself
within your equipment control system.
Barcode reading devices are connected to the RS-232 Port as described in Section
3.3, and are powered directly from Solo. If a barcode reader is attached and data
entry is requested from the user, the barcode reader will generate a tone indicating
it has been powered on. Scanned data appears on the LCD and is accepted by
pressing the
key, or cleared by pressing the
or BACKSP key on the
keypad.
If Solo is operating on battery power, you will have 30 seconds to scan a barcode
after the reader has been powered on. The 30-second timeout is provided to
prevent excessive battery drain as the power consumed by the reader is
significant.
IMPORTANT:
NEVER CONNECT A BARCODE READER ACCESSORY TO Solo
IF THE POWER IS ON! BARCODE READER ACCESSORIES ARE
POWERED FROM Solo AND MAY BE DAMAGED IF “HOTPLUGGED” INTO THE Solo RS-232 PORT. ALWAYS TURN OFF
Solo BEFORE CONNECTING A BARCODE READER
ACCESSORY.
Operation/Chapter 4 # Page 26
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4.3 Test Modes
Solo provides three test modes to measure volumetric accuracy and the occlusion
pressure limit of an infusion device. The next sections describe each test mode in detail.
4.3.1. Rate+Volume Test
The Rate+Volume Test measures average flow rates from 1 to 1200 ml/hr and
effused volume up to 9999 ml. The infusion device under test connects to the
input tubing set of Solo as shown in Figure 2 of Section 3. Fluid effused from
the infusion device enters the fluid input channel, passes through the flow sensor
of the instrument and exits via the fluid output channel. While the Rate+Volume
Test is in progress, the LCD will display the average flow rate, total effused
volume, and the elapsed time since the test was started.
When a Rate+Volume Test is stopped, a test result summary is generated and
displayed on the LCD. The test result summary includes the following test
information which may be saved (Section 4.4.6) or discarded.
<
<
<
<
Pump ID (control number)
Average Flow Rate (ml/hr)
Total Effused Volume (ml)
Total Elapsed Time (HH:MM:SS)
The Pump ID uniquely identifies the device under test, and is input by the user
prior to test execution.
Note:
The fluid volume entering Solo will not equal that exiting as there is a
water reservoir inside the unit which will hold an indeterminate portion
of the effused fluid.
4.3.2. Occlusion Pressure Test
The Occlusion Pressure Test measures maximum pressure generated by an
infusion device when its output is occluded. The infusion device under test
connects to the input tubing set of Solo as shown in Figure 2 of Section 3. Fluid
effused from the infusion device enters the fluid input channel, and is blocked by
an internal valve. A pressure sensor measures the rising pressure developed
against the occlusion, and this instantaneous pressure is displayed on the Solo
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INFUTEST SOLO OPERATING MANUAL
LCD while the test is in progress. The instantaneous pressure is displayed in units
of mmHg and one other user-defined unit (psi, kPa or bar). Refer to Section 4.5.8
for details regarding pressure unit selection.
When an Occlusion Pressure Test is stopped, a test result summary is generated
and displayed on the LCD. The test result summary contains the following
information which may be saved (Section 4.4.6) or discarded.
<
<
<
<
Pump ID (control number)
Maximum measured pressure (mmHg)
Maximum measured pressure (psi, kPa or bar)
Time at which maximum pressure was generated (MM:SS)
It is also possible to start an Occlusion Pressure Test “on the fly” while a
Rate+Volume Test is already in progress. Pressing the
key while a flow
test is in progress will automatically terminate the Rate+Volume Test and
immediately start an Occlusion Pressure Test. When the Occlusion Pressure Test
is terminated by the user, a test result summary is generated and displayed on the
LCD. The test summary is a combination of the Rate+Volume Test summary
and the Occlusion Pressure Test summary.
Solo’s pressure sensor can withstand up to 50 PSI of applied pressure. If
this pressure limit is exceeded, the Occlusion Pressure Test will terminate
automatically to prevent damage to the pressure sensor.
4.3.3. Auto Test
The Auto Test automatically performs a timed Rate+Volume Test followed by an
optional Occlusion Pressure Test. The duration of each test is preset by the user
via the “Auto Test Setup” function in the Options Menu. Refer to Section 4.5.9
to configure the Auto Test.
The Auto Test uses an Infusion Timer and Occlusion Timer to set the duration of
the Rate+Volume Test and Occlusion Pressure Test respectively. The Infusion
Timer may be set to any value in the range 10 - 9999 seconds, whereas the
Occlusion Timer value must be chosen from preset values: OFF, 1 minute, 2
minutes, 3 minutes, 5 minutes, 10 minutes, or 20 minutes.
When an Auto Test is stopped, a test result summary is generated and displayed
on the LCD. The test result summary includes the following test information
which may be saved (Section 4.4.6) or discarded. The occlusion pressure data is
omitted if only a flow test is conducted.
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<
<
<
<
<
<
<
Pump ID (control number)
Average Flow Rate (ml/hr)
Total Effused Volume (ml)
Total Elapsed Time (HH:MM:SS)
Maximum measured pressure (mmHg)
Maximum measured pressure (psi, kPa or bar)
Time at which maximum pressure was generated (MM:SS)
4.4 Test Execution
The steps below outline how a typical test is conducted on Solo.
Test Execution Overview
Step 1:
Set up a test
a) Select a test mode
b) Enter a pump ID associated with the device under test
c) Flush Solo
Step 2: Run the test
Step 3: Monitor the test in progress
Step 4: Stop the test
Step 5: View the test result summary
Step 6: Save the summary as a Test Record (optional)
To execute a test, connect the infusion device to Solo and prime as described in Section
3.2. The following sections detail each of the steps listed above.
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4.4.1. Setting Up and Running a Test
a.
Press
while viewing the RUN TEST/OPTIONS prompt.
b.
You will be prompted to select a test mode. Select a test mode by scrolling
through the three different options using the
key, and press
to select the displayed test mode.
c.
You will be prompted to enter a Pump ID:
ENTER PUMP ID:
_
****
Figure 11
The Pump ID should uniquely identify the device under test, such as an
equipment control number or serial number. The maximum number of
characters that may be input is limited to 16, and the first character in the
ID must not be a blank space. Enter a Pump ID using the keypad or
accessory barcode reader and press
. Refer to Section 4.2 for keypad
and barcode reader operation.
Alternatively, the Pump ID entry may be skipped by pressing
with
no characters entered. Note however, a Pump ID must be entered before
test results may be saved to non-volatile memory in Solo.
d.
Solo now displays a reminder to flush the system. Always flush the fluid
channel before starting any test. Use the technique described in Section 3.2
for priming the fluid channel. Injecting approximately 5 cc of water should
be sufficient to purge any air bubbles present.
e.
Once the system is flushed, press
and start the infusion pump as
directed on the LCD. The selected test is now in progress.
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4.4.2. Starting a Pressure Test from a Running Flow Test
While a Rate+Volume Test is in progress, an Occlusion Pressure Test may be
initiated by pressing the
key. This will terminate the flow test in progress
and immediately start a pressure test. The LCD will change to display the
instantaneous pressure, and when the pressure test is complete, a test summary
with both the flow and pressure results will be displayed.
4.4.3. Monitoring a Test in Progress
When a Rate+Volume Test is started by the user, Solo will wait until fluid flow is
detected, and then proceed to take measurements. While Solo is detecting initial
flow, the display will flash indicating that a test has been started, but an initial
measurement has not yet been made.
Once the initial measurement is completed, the LCD will display the average flow
rate (RATE) on the upper line of the LCD and either the total volume effused
(VOL.) or the elapsed time since the test was started (TIME) in hours, minutes
and seconds on the lower line of the LCD as shown in Figure 12 and Figure 13.
The LCD will update periodically as new measurement data is obtained
(approximately after every 0.15 ml of fluid delivery).
RATE: 100.4 ml/hr
VOL.: 29.45 ml
Figure 12
RATE: 100.4 ml/hr
TIME: 00:17:36
Figure 13
Toggle the lower line of the LCD between volume and time by pressing any of
the four arrow keys on the keypad (
).
Operation/Chapter 4 # Page 31
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Similarly, while an Occlusion Pressure Test is in progress, the LCD will display
the instantaneous pressure (OCCL PR.) in user-defined units (psi, kPa, or bar) on
the upper line of the LCD and either the instantaneous pressure in mmHg or the
elapsed time since the test was started (TIME) in minutes and seconds on the
lower line of the LCD as shown in Figure 14 and Figure 15.
OCCL PR.:
TIME:
2.4 psi
01:38
Figure 14
OCCL PR.:
2.4 psi
125 mmHg
Figure 15
Toggle the lower line of the LCD between pressure and time by pressing any of
the four arrow keys on the keypad:
,
,
,
.
4.4.4. Stopping a Test
To stop a test in progress, simply press the
test result summary will appear on the LCD.
key. The test terminates, and a
4.4.5. Viewing a Test Summary
After a test has been terminated, a test summary appears on the LCD containing
all or some of the following test results depending on the type of test conducted
(i.e., flow only, pressure only or flow+pressure).
<
<
<
<
<
<
<
Pump ID (control number)
Average Flow Rate (ml/hr)
Total Volume Effused (ml)
Flow Test Duration (HH:MM:SS)
Peak Occlusion Pressure (mmHg)
Peak Occlusion Pressure (PSI, kPa, or bar)
Time of Peak occlusion pressure (MM:SS)
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The LCD will display the test results two lines at a time. Use the arrow keys
(
) to scroll forward and (
) to scroll backward
through the test results.
To save the test summary in the non-volatile memory of Solo, proceed to section
4.4.6. To clear the test summary and return to the RUN TEST/ OPTIONS
prompt, press
,
or
.
Once the Solo display returns to the RUN TEST/OPTIONS prompt,
unsaved test results are not recoverable.
4.4.6. Saving Test Results
Solo can store up to 123 test result summaries in its non-volatile memory. Each
test summary is stored as a Test Record and includes a Pump ID, flow and/or
pressure data along with a date and time stamp.
To save the test results to memory, press the
key while viewing the test
summary (Section 4.4.5). Solo will save all results shown in the test result
summary along with the current date and time to a record in memory.
Note that in order to save a record, a Pump ID must be entered. If, at the start of
the test, a Pump ID was not entered, a prompt will appear after pressing the
key. At this point, enter a Pump ID via the keypad or accessory barcode
reader and press
.
After each save operation, Solo will display the amount of memory remaining, as
shown in Figure 16.
RECORD # 3 SAVED!
RECORDS AVAIL.: 120
Figure 16
If the memory is full when
is pressed, Solo will display an error message
and the Test Record will not be saved.
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4.5 Option Menu Functions
The Options Menu provides the following functions.
1. VIEW RECORDS
View saved records; Delete single records; Output
single records to a PC or printer.
2. OUTPUT RECORDS
Output all or selected Test Records to a PC or printer.
3. ERASE MEMORY
Erase all Test Records stored in non-volatile memory.
4. PACK MEMORY
Compress the non-volatile Test Record memory to
eliminate any gaps caused by deleting records.
5. SET CLOCK
Set the real-time clock to the current date and time.
6. AUTO TEST SETUP
Configure the Auto Test.
7. PRESSURE UNITS
Select occlusion pressure units: psi, kPa or bar.
8. EDIT SOLO ID
Edit the ID (control number) of the Solo.
9. BATTERY STATUS
Check the internal battery voltage level.
10. EXIT
Exit the Options Menu and return to the RUN
TEST/OPTIONS prompt.
To access the Options Menu, press the
key while viewing the RUN TEST/
OPTIONS prompt . The display appears showing the first menu item as shown in
Figure 17.
*** OPTIONS MENU ***
1. VIEW RECORDS
Figure 17
To navigate through the Options Menu, use the arrow keys to scroll forward (
) and backward (
). To select a particular menu item, press
with the desired menu item displayed. To return to the RUN TEST/OPTIONS
prompt, press
. The following sections describe the functions provided in the
Options Menu.
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4.5.1. Viewing Test Records
a.
Press
when viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
The LCD will display item 1. VIEW RECORDS as shown in Figure 17.
Press
to select this function.
c.
The LCD will show the most recent Test Record along with its Pump ID
(Figure 18):
TEST RECORD # 24
ID: ECN 12345A
Figure 18
Use the up and down arrow keys (
) to scroll through the
different Test Records available for viewing, and use the right and left arrow
keys (
) to scroll through the test data contained in a
particular Test Record.
d.
To exit the View Records function and return to the Options Menu,
press
or
.
4.5.2. Delete a Single Test Record
A single Test Record stored in Solo’s memory may be deleted via the View
Records function. Follow the procedure outlined below to permanently delete a
Test Record from memory.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
The LCD will display item 1. VIEW RECORDS. Press
function.
Operation/Chapter 4 # Page 35
to select this
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c.
Select the record to delete using the up and down arrow keys (
) and press
.
d.
A prompt appears to either output or delete the selected record. Press the
down arrow key to move the selection arrow (>) to point to DELETE
RECORD and press
.
OUTPUT RECORD
> DELETE RECORD
Figure 19
e.
Another prompt appears to confirm deletion:
DELETE RECORD? > NO
YES
Figure 20
The up and down arrow keys (
) will toggle the selection
arrow (>) between NO and YES. Press the down arrow key to move the
selection arrow to point to YES and press
. The record will now be
permanently deleted from memory, and the display returns to the main
Options Menu.
4.5.3. Transferring a Single Test Record to a PC/Printer
A single Test Record may be output from Solo using the View Records function.
Records may be output via RS-232 to a PC or serial printer, or via USB to a PC
running the DTP Solo accessory software application. To install DTP Solo on
your PC, refer to Section 3.4. To transfer Test Records to a PC via RS-232 using
HyperTerminal, refer to Section 3.5
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a.
Connect the PC or printer to Solo with the appropriate interface cable and
adapter (Section 3.3). If sending Test Records to a PC over USB, run the
DTP Solo application.
b.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
c.
The LCD will display 1. VIEW RECORDS. Press
function.
d.
Select the record to output using the up and down arrow keys
(
) and press
.
e.
A prompt will appear to either output or delete the selected record. With
the selection arrow (>) pointing to OUTPUT RECORD (Figure 21),
press
.
to select this
> OUTPUT RECORD
DELETE RECORD
Figure 21
f.
Another prompt will appear to either output the selected Test Record via
USB or RS-232 (Figure 22):
OUTPUT TO
> USB
RS232
Figure 22
Using the up and down arrow keys (
) , toggle the selection
arrow (>) between USB and RS-232 to select the desired output port and
press
.
Note:
An attempt to send data out via the RS-232 port when a bar code reader is
connected to the RS-232 port will result in a Port Off-line Error as
described in Section 6.6. For information on other error messages, refer to
Chapter 6.
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4.5.4. Transferring Multiple Test Records to a PC/Printer
The Output Records function allows the user to output multiple Test Records
from Solo via RS-232 to a PC or serial printer, or via USB to a PC running the
DTP Solo accessory software application. To install DTP Solo on your PC, refer
to Section 3.4. To transfer Test Records to a PC via RS-232 using
HyperTerminal, refer to Section 3.5.
a.
Connect the PC or printer to Solo with the appropriate interface cable and
adapter (Section 3.3). If sending Test Records to a PC over USB, run the
DTP Solo application.
b.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
c.
Use the arrow keys to scroll to item 2. OUTPUT RECORDS and
press
.
d.
A prompt will appear to either output the selected Test Record via USB or
RS-232 (Figure 23):
OUTPUT TO
> USB
RS232
Figure 23
Use the up and down arrow keys (
) , to toggle the selection
arrow (>) between USB and RS-232 to select the desired output port and
press
.
e.
If USB is chosen, all Test Records will be output to the DTP Solo
application within a few seconds. If any error messages arise, refer to
Chapter 6.
f.
If RS-232 is chosen, another prompt will appear to either output select
records, or all records (Figure 24):
Operation/Chapter 4 # Page 38
INFUTEST SOLO OPERATING MANUAL
> SELECT RECORDS
ALL RECORDS
Figure 24
Use the up and down arrow keys (
) to toggle the selection
arrow (>) between SELECT RECORDS and ALL RECORDS and press
.
g.
If ALL RECORDS was chosen, data transfer begins immediately. If
SELECT RECORDS was chosen, another prompt appears to select which
records to output (Figure 25):
OUTPUT LAST 2
RECORDS
Figure 25
Use the up and down arrow keys (
) to increment and
decrement the number of records to output and press
. Data
transfer will begin immediately. If any error messages arise, refer to
Chapter 6.
h.
If Test Records were output via the RS-232 Port, a prompt will appear to
clear all memory contents (Figure 26):
CLEAR MEMORY?
> NO
YES
Figure 26
Use the up and down arrow keys (
) to move the selection
arrow (>) between YES and NO. Select YES to permanently erase all Test
Records in memory or press NO to return to the main Options Menu
without clearing the memory , and press
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4.5.5. Erasing Memory Contents
Follow the instructions below to erase all Test Records stored in the non-volatile
memory. Note: Executing this function will permanently delete all Test
Records.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 3. ERASE MEMORY and press
.
c.
A prompt appears asking for confirmation to clear the memory. Use the up
and down arrow keys to toggle the selection arrow (>)between YES and NO.
To abort the Erase Memory operation, move selection arrow to NO and
press
. To continue with the Erase Memory function, move the
selection arrow to YES and press
.
d.
Another prompt appears again asking for confirmation to clear the memory
since this operation is permanent (Figure 27):
ARE YOU SURE?
> NO
YES
Figure 27
Select either YES or NO using the up and down arrow keys (
)
and press
. The Erase Memory function then executes, and a
completion message is displayed on the LCD when all the memory has been
cleared. The display will return to the main Options Menu automatically.
4.5.6. Packing Memory
Test Records are stored in Solo’s non-volatile memory. When a single Test
Record is deleted following the procedure described in Section 4.5.2, a gap is left
in memory where the record was previously stored. The Pack Memory function
eliminates all such gaps in memory to free space for additional Test Records. The
following instructions will execute the Pack Memory function:
Operation/Chapter 4 # Page 40
INFUTEST SOLO OPERATING MANUAL
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 4. PACK MEMORY and press
c.
The Pack Memory function executes, and will display a completion message
on the LCD when all the memory has been packed. The display will then
return to the main Options Menu.
.
4.5.7. Setting the Real-Time (RT) Clock
Solo has a battery-backed real-time clock that maintains the current date (month,
day, year) and time in 24-hour format (hours, minutes). Follow the instructions
below to change the real-time clock setting.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 5. SET RT CLOCK and press
.
The current date and time setting appears on the LCD as shown in Figure
28.
DATE:>2004< JAN
TIME: 09 : 00
01
Figure 28
c.
Use the right and left arrow keys (
) to move the selection
arrows (> <) to the date/time field you wish to modify. Then use the up
and down arrow keys (
) to increment or decrement the
selected date/time field.
d.
Press
to accept the new clock setting, or press
or
return to the main Options Menu without modifying the clock.
Operation/Chapter 4 # Page 41
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4.5.8. Selecting Pressure Units
In the Occlusion Pressure Test, pressure is measured in units of mmHg and
another user defined unit; psi, kPa, or bar. To select the user defined unit of
measure, follow the instructions below. The default selection is psi.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 6. PRESSURE UNITS and
press
.
c.
Use the arrow keys (
) to scroll through the
three different pressure units (psi, kPa, bar). Press
to select the
currently displayed pressure units, or press
to return to the main
Options Menu without any changing the pressure unit selection.
4.5.9. Configuring the Auto Test
In Auto Test mode, Solo will run a Rate+Volume Test followed by an optional
Occlusion Pressure Test. The duration of these two tests are configured by
setting the Infusion Timer and Occlusion Timer. To set the Infusion Timer
and/or Occlusion Timer, follow the instructions below.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 7. AUTO TEST SETUP, and
press
.
c.
The current Infusion Timer setting will appear on the lower line of the
LCD. To keep the current infusion timer setting, press
or
,
and the display advances to the Occlusion Timer setting.
To change the Infusion Timer setting, enter a new timer value using the
numeric data keys (secondary functions) on the keypad and press
.
Note the Infusion Timer can hold a value in the range 10 - 9999 seconds. If
a value less than 10 seconds is entered, the timer will be set to a default
value of 10 seconds.
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d.
The display advances to show the current Occlusion Timer setting on the
lower line of the LCD. To keep the current Occlusion Timer value, press
or
, and the display returns to the Options Menu.
To change the occlusion timer setting, use the up and down arrow keys
(
) to increase or decrease the timer value respectively. Note
that the occlusion timer settings are predefined, and must be selected from
one of the following discrete timer values: OFF; 1 minute, 2 minutes, 3
minutes, 5 minutes, 10 minutes, 20 minutes. Press
to select the
currently displayed occlusion timer setting, or press
to return to the
main Options Menu without changing the Occlusion Timer setting.
4.5.10. Editing the Solo ID
In a particular facility, there may be more than one Solo, or a need to identify Solo
by its control number. To uniquely identify each instrument, an ID field is
provided. The field is a 20-character alphanumeric identifier stored in Solo’s nonvolatile memory. The default ID is “------”. To edit the ID, follow the
instructions outlined below.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
main Options Menu.
b.
Use the arrow keys to scroll to item 8. EDIT SOLO ID and press
The current ID setting will appear on the lower line of the LCD:
.
Solo ID:
-----Figure 29
To edit the current ID, press
. Press
the Options Menu without changing the ID.
c.
or
to return to
Enter a new ID either via the alphanumeric data keys (secondary functions)
on the keypad or via the accessory barcode reader and press
. Refer
to Section 4.2 for barcode reader operation if Solo is identified using a
barcode label. The new ID is saved, and the display will return to the main
Options Menu.
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4.5.11. Checking the Battery Status
Follow the instructions below to check the voltage of the internal NiMH battery.
If the battery capacity is near “empty”, recharge the battery following the
procedure outlined in Section 4.6.
a.
Press
while viewing the RUN TEST/OPTIONS prompt to enter the
Options Menu.
b.
Use the arrow keys to scroll to item 9. BATTERY STATUS, and
press
. A bar graph will appear on the LCD (Figure 30) showing the
battery potential. The E on the bar graph corresponds to “Empty” and the
F corresponds to “Full”.
BATTERY STATUS:
E #########
F
Figure 30
c.
To exit the Battery Status function, press
to the main Options Menu.
,
or
to return
4.6 Recharging the Battery
Solo is powered by an internal NiMH battery with sufficient capacity to provide
approximately 30 hours of continuous operation. When the battery approaches
complete discharge, the display will flash with a Low Battery warning message (Section
6.1).
To recharge the battery, connect the AC adapter supplied with Solo to the jack on Solo’s
rear panel, then plug the adapter into a grounded wall outlet. Use only the adapter
supplied with Solo to recharge the battery. It will require approximately 14 hours to fully
recharge the battery. However, with the AC adapter plugged into the unit, normal
operation will resume, and Solo may be operated while the battery charges in the
background.
Note: If the battery is severely discharged, it may be necessary to charge the battery for a
short period of time before Solo will power-up.
Operation/Chapter 4 # Page 44
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5. REMOTE CONTROL
This chapter describes Solo’s serial communications features and
specifies commands used to request information from Solo, or to remotely
control its operation.
5.1 General Description
The RS-232 Port provides an interface for controlling Solo remotely using an external
device such as a personal computer or automated test system. Solo will recognize a
predefined set of commands issued to its RS-232 Port allowing the external device to
start a test, stop a test, or retrieve test results automatically.
Remote commands allow the creation of simple programs on a personal computer that
will automatically perform and document a pump test according to a desired protocol.
The command set is also compatible with automated test instrumentation, such as
Datrend’s ES601Plus or medTester 5000C from Fluke. Refer to the operator’s manual
for your automated test instrument, especially with regard to port settings, cable wiring,
data transmission format and data packet length. The serial protocol of Solo is 9600
Baud, 8 Data Bits, No Parity, 1 Stop Bit (9600, N, 8, 1 - see Section 1.5)
The following sections present Solo’s remote control command set. When using these
commands, it is assumed the user has primed and flushed Solo prior to enabling the
controlling device, and the controlling device is connected to Solo using the appropriate
interface cable as described in Section 3.3. If using a program on a personal computer to
command Solo, allow a delay of at least 100 milliseconds between consecutive remote
commands to provide enough time for Solo to process and respond to each received
command.
An example Visual Basic® program illustrating the use of the remote control command
set is included on the DTP Solo CD-ROM provided with Solo. Alternatively, you may
download the example program from the Datrend website at www.datrend.com.
Remote Control/Chapter 5 # Page 45
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5.2 Command Set
There are 6 commands in Solo’s remote control command set. Each command consists
of two upper case ASCII characters followed by a carriage return character (<CR> or
\r). Solo will respond to remote commands received at the RS-232 Port except when a
function in the Options Menu is executing (i.e., View Records, Output Records, etc.) or
when data entry is being requested from the user.
If Solo receives a valid RS-232 command, it will execute the command, and return either
an asterisk character followed by a carriage return (*<CR>) or a packet of data back to
the control device depending on the type of command issued. If a command is
syntactically incorrect, or not recognized by Solo, a question mark character followed by
a carriage return (?<CR>) is transmitted back to the controlling device.
5.2.1. Run Flow Test
Syntax:
RF<CR>
Description:
The Run Flow Test command initiates a Rate+Volume Test.
Returns:
(1)
?<CR> Syntax error; Invalid command.
(2)
*<CR> Acknowledged, Rate+Volume Test is started.
5.2.2. Run Pressure Test
Description:
The Run Pressure Test command starts an Occlusion Pressure
Test. This command may also be used while a Rate+Volume
Test is in progress to immediately terminate the flow test and
start the pressure test. This remote command is equivalent to
manually pressing the
key on the keypad while a flow test
is in progress.
Syntax:
RP<CR>
Returns:
(1)
?<CR> Syntax Error; Invalid Command.
(2)
*<CR> Acknowledged, Occlusion Pressure Test is
started.
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5.2.3. Stop Test
Description:
The Stop Test command will terminate the test currently in
progress and display the test summary on the LCD. This remote
command is equivalent to stopping a test manually by pressing
the
key.
Syntax:
ST<CR>
Returns:
(1)
?<CR> Syntax error; Invalid Command.
(2)
*<CR> Acknowledged, test in progress successfully
terminated.
5.2.4. Get Flow Result
Description:
The Get Flow Result command retrieves the flow measurement
result summary. This command is only recognized while a test
summary containing flow data is displayed on the LCD. Since
the test result summary appears on the LCD immediately after a
test has been terminated, the Get Flow Result command is
generally issued after the Stop Test command.
Syntax:
GF<CR>
Returns:
(1)
?<CR> Syntax error; Invalid Command.
(2)
A character string with the format:
hh:mm:ss VVVVV ml AAAAA ml/h <CR>
where hh:mm:ss is the elapsed time of the test in
hours, minutes and seconds, VVVVV is the total volume
effused, and AAAAA is the average flow.
Remote Control/Chapter 5 # Page 47
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5.2.5. Get Pressure Result
Description:
The Get Pressure Result command retrieves the pressure
measurement result summary. This command is only recognized
while a test summary containing pressure data is displayed on the
LCD as described in Section 4.4.5. Since the test result summary
appears on the LCD immediately after a test has been terminated,
the Get Pressure Test command is generally issued after the Stop
Test command.
Syntax:
GP<CR>
Returns:
(1)
?<CR> Syntax error; Invalid Command; No pressure
results available.
(2)
A character string with the format:
MAX PPPP uuu pppp mmHg at mm:ss <CR>
where PPPP is the peak pressure in user defined units,
uuu are the user defined units (psi, kPa or bar), pppp
is the peak pressure in mmHg and mm:ss is elapsed time
at which the peak pressure was detected in minutes and
seconds.
5.2.6. Data Download
Description:
The Data Download command retrieves all saved Test Records
stored in Solo’s non-volatile memory.
Syntax:
DD<CR>
Returns:
(1)
?<CR> Syntax error; Invalid command; No Test
Records in memory.
(2)
An output report containing all Test Records stored in
memory in the format shown below. Records are output
starting with the most recent.
Remote Control/Chapter 5 # Page 48
INFUTEST SOLO OPERATING MANUAL
Datrend Systems Inc.
Infutest Solo S/N IS04120123
Solo ID: -----Version 1.00
RECORD #:
24
PUMP I.D.: ECN12345A
TEST DATE: 15 Jan 2004
TEST TIME: 10:21
AVG. RATE: 106.4 ml/hr
INF. VOL.: 24.58 ml
INF. TIME: 00:14:33
PEAK OCCL PR: 14.3 psi
739 mmHg
PEAK OCCL PR AT: 02:14
RECORD #:
PUMP I.D.:
TEST DATE:
TEST TIME:
AVG. RATE:
INF. VOL.:
INF. TIME:
.
.
.
23
CN00045-9
12 Jan 2004
08:55
198.7 ml/hr
39.78 ml
00:12:01
RECORD #:
1
PUMP I.D.: ABBOTT PLUM
TEST DATE: 05 Jan 2004
TEST TIME: 15:53
AVG. RATE: 391.0 ml/hr
INF. VOL.: 11.15 ml
INF. TIME: 00:03:25
PEAK OCCL PR: 11.8 psi
604 mmHg
PEAK OCCL PR AT: 01:57
Technician: ________________________
Date: ______________________________
END OF DATA
Figure 31
Remote Control/Chapter 5 # Page 49
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Error and Warning Messages
This chapter describes errors and warnings that may be displayed by
Solo, and methods of recovery from such error conditions.
6. ERROR & WARNING MESSAGES
There are several error and warning messages that may occur. Some error conditions
may be corrected, while others are irreversible. This section details the different error
and warning messages, and how to deal with them.
6.1 Low Battery
The Low Battery warning (Figure 32) message appears when the internal battery voltage
drops below a minimum safe operating level. To clear this warning message, recharge
the internal battery following the procedure outlined in Section 4.6.
*** LOW BATTERY! ***
* PLUG IN CHARGER! *
Figure 32
Note: This message will not display if a pump test is in progress.
Error and Warning Messages/Chapter 6 # Page 51
INFUTEST SOLO OPERATING MANUAL
6.2 Dead Battery
The Dead Battery error message (Figure 33) appears if the internal NiMH battery in
Solo fully discharges during use. After this error message is displayed on the LCD, the
unit will power itself off. To recover from the Dead Battery error, turn the power switch
to the OFF position and connect the AC adapter to the unit. Recharge the battery as
described in Section 4.6.
*** DEAD BATTERY ***
* PLUG IN CHARGER! *
Figure 33
Note: If the battery is severely discharged, Solo may not power up. If this
happens, it will be necessary to charge the battery for a short period of time
before normal operation is restored.
6.3 Flow Sensor Unprimed
The Flow Sensor Unprimed warning message (Figure 34) appears if Solo is not primed
with water when the unit is powered up. The warning message is cleared upon a key
press and normal operation will resume. To avoid this warning message, remember to
keep the flow sensor primed between uses (see Section 3.2).
WARNING! FLOW SENSOR
UNPRIMED! HIT A KEY.
Figure 34
Error and Warning Messages/Chapter 6 # Page 52
INFUTEST SOLO OPERATING MANUAL
6.4 Calibration Fault
The Calibration Fault error message (Figure 35) appears if calibration parameters stored
in Solo’s non-volatile memory have been corrupted. To clear this error message, try
restarting Solo by powering off, waiting for 15 seconds, and powering on. If the
problem persists, contact Datrend Customer Service at 1-800-667-6557 (604-291-7747
outside of North America) or via email at customerservice@datrend.com.
CALIBRATION FAULT!
CONSULT MANUAL...
Figure 35
6.5 Pressure Zero Fault
The Pressure Zero Fault error message (Figure 36) appears if there is excessive pressure
at Solo’s input when the unit is powered on. To clear this fault message, remove any
pressure applied to the input and restart Solo.
PRESSURE ZERO FAULT!
CONSULT MANUAL...
Figure 36
If Solo is left in a partially primed state (e.g. the glass and tubing are filled with sections
of air and small columns of water) simply connecting then disconnecting a collection
vessel to the O/P may result in enough pressure being applied then stored in the system
to cause a fault when the unit is powered on and the self test is performed.
There are two methods for clearing the fault and removing the pressure.
One method is to release the pressure by opening the I/P shut-off valve. This can be
accomplished by connecting the appropriate coupling to the I/P shut off valve thus
releasing the pressure. The applied coupling may not be connected to an Infusion pump
or any other device, it must be open to atmosphere.
Error and Warning Messages/Chapter 6 # Page 53
INFUTEST SOLO OPERATING MANUAL
The second method is to prime the unit and then remove any connections to the I/P
and O/P couplings.
In either case, re-power the unit.
If the problem persists, contact Datrend Customer Service at 1-800-667-6557
(604-291-7747 outside of North America) or via email at customerservice@datrend.com.
6.6 Port Off-line
The Port Off-line error message (Figure 37 or Figure 38) will appear if the RS-232 or
USB cable is not properly connected between Solo and the peripheral device. Clear this
error message by checking all cabling for proper wiring connections (see Section 3.3).
****** ERROR! ******
RS232 PORT OFF-LINE!
****** ERROR! ******
USB PORT OFF-LINE!
Figure 37
Figure 38
6.7 Download Application Not Running
The Download Application Not Running error message (Figure 39) appears if an
attempt is made to output Test Records from Solo to a PC via USB without DTP Solo
running on the PC. Make sure Solo is properly connected to the PC using a standard
USB cable, and that the DTP Solo application is running on the PC.
If DTP Solo is running, and this error message still appears, try restarting the program,
or unplug and re-plug the USB cable into the PC. Remember, the DTP Solo application
will not recognize the attached device if Solo is executing an Options Menu function (i.e.
View Records, Output Records, etc.) or requesting a Pump ID from the user.
DOWNLOAD APPLICATION
NOT RUNNING ON PC!!!
Figure 39
Error and Warning Messages/Chapter 6 # Page 54
INFUTEST SOLO OPERATING MANUAL
6.8 Memory Full
The Memory Full error message (Figure 40) appears if an attempt to save test results is
made and the non-volatile memory is full. Solo is capable of storing up to 123 Test
Records. Press
to return to the test result summary. To free memory space for
future save operations, execute the Delete Record function (see Section 4.5.2) and / or
the Pack Memory function (see Section 4.5.6), or the Erase Memory function (see
Section 4.5.5).
ERROR: MEMORY FULL!
PRESS ENTER...
Figure 40
6.9 Injection Failure
The Injection Failure error message (Figure 41) appears during a flow test if there is an
air bubble residing in the fluid pathway, or if there is fault with the internal injector
valve. Try re-priming and flushing Solo as described in Section 3.2, and then attempt to
start a Rate+Volume Test. If the Injection Failure error message persists, contact
Datrend Customer Service at 1-800-667-6557 (604-291-7747 outside of North America)
or via email at customerservice@datrend.com.
INJECTION FAILURE
SYSTEM NOT PRIMED!
Figure 41
Error and Warning Messages/Chapter 6 # Page 55
INFUTEST SOLO OPERATING MANUAL
6.10
Over-Pressure Alarm
The Over-Pressure Alarm (Figure 42) is a result of excessive pressure ( > 50 PSI)
applied to the Solo input. If the input pressure exceeds the maximum allowable pressure
of 50 PSI, the pressure test in progress will automatically stop and the Over-Pressure
Alarm is displayed. Pressing the
key will clear this error message to display the
test result summary.
OVER-PRESSURE ALARM!
PRESS ENTER...
Figure 42
Error and Warning Messages/Chapter 6 # Page 56
INFUTEST SOLO OPERATING MANUAL
APPENDIX A.
BACK PRESSURE TESTING
The user may apply a back pressure to the infusion device under test to oppose the flow
from the device. Back pressure of up to 300 mmHg may be applied during the
Rate+Volume Test at the output of Solo.
This appendix describes the apparatus and provides instructions for testing an infusion
device with a pneumatically-applied back pressure. The test apparatus and method
discussed are similar to those recommended by the Association for the Advancement
of Medical Instrumentation (AAMI) in their proposed standard for infusion devices.
Connect the apparatus shown in Figure 43 to the output of Solo as illustrated. The flask
should have a large internal volume (1 to 2 litres) so that the fluid level within the flask
does not change substantially during the test. The components and all seals should be
capable of withstanding the maximum pressure applied to the system.
Figure 43: Apparatus for Applying Back Pressure
Appendix A # Page 57
INFUTEST SOLO OPERATING MANUAL
Alternatively, a syringe bulb may be used to pressurize the flask instead of the
compressed air source and regulator valve shown in Figure 43. This approach, although
simple, has the disadvantage in that the back pressure is unregulated. If air leaks are
present within the system, or if the water level within the flask changes substantially, the
back pressure will be affected and the test results may be invalid.
To perform a Rate+Volume Test with an applied back pressure:
a. Power up Solo with NO PRESSURE applied to the output. During its
power-on self-test, Solo will auto-zero the internal pressure sensor.
b. If a back pressure is detected at the time of power-up, Solo will produce an
alarm. Refer to Section 6 if an alarm condition arises.
c. While viewing the RUN TEST/OPTIONS prompt, the fluid system of
Figure A-1 may be primed with water as described in Section 3.2 and the
flask pressurized up to a maximum of 300 mmHg before starting the test.
Under no circumstances should a vacuum be applied to the output as
this may damage the internal pressure sensor.
d. Water may be pumped out of the flask into Solo’s output during
pressurization of the apparatus. If this happens, reprime Solo once the
apparatus has been pressurized so that the tubing connecting the output to
the flask is completely filled with water.
e. Prepare the device under test, then set up and start a Rate+Volume Test
(Section 4.4). Note that the back pressure is not displayed by Solo or saved
as part of a Test Record.
f. The back pressure should not be allowed to change for the duration of the
test. IV tubing is compliant, and an increase in back pressure may cause a
drop in measured flow and volume simply because the IV tubing is being
stretched by the increased pressure in the system. Variations in device
performance may therefore be more an effect of the tubing than of the
device itself.
Appendix A # Page 58
INFUTEST SOLO OPERATING MANUAL
APPENDIX B. OPERATIONAL OVERVIEW
B.1 General Description
Figure 44 shows a block diagram of Solo. During a flow test, test fluid enters the unit
via its fluid input, passes through the fluid channel, drains into a collection tank and
eventually exits via the fluid output. As fluid passes through the internal fluid channel, a
flow sensor and injector valve (INJ) co-ordinate to measure flow rate and effused
volume. During an Occlusion Pressure Test, fluid is blocked from passing through the
internal fluid channel using an occluder valve (OCV). Occlusion pressure is then
measured with a pressure sensor connected at the fluid input via a tee.
Figure 44: Infutest Solo block diagram
Analog signals from both the flow and pressure sensors are converted to digital, and
further processed by an 8-bit microcontroller. The microcontroller operates the LCD,
keypad, piezo-buzzer and RS-232 interface, controls test execution, and interfaces to the
USB port through a USB controller.
Appendix B # Page 59
INFUTEST SOLO OPERATING MANUAL
Calibration data for the flow and pressure sensors are stored in the EEPROM memory
of Figure 44. Calibration of Solo is completely software based - there are no manual
adjustments or controls inside the unit.
B.2 Flow Measurement System
Figure 45 diagrams Solo’s flow sensor consisting of an occluder valve, injector valve, 21gauge needle, glass tube, and collection reservoir. The sensor’s glass tube is elevated
above the fluid inlet and outlet ports. With the system primed, the nominal 6" column
of water leading from the output of the glass tube into the collection reservoir develops
a pneumatic pressure on the air contained inside the enclosed reservoir. This pressure is
transmitted to the input of the injector valve though tubing. When the normally-closed
injector valve opens, it introduces an air bubble approximately 1 cm in length into the
test fluid through the needle located at the sensor input. During bubble injection, the
occluder valve blocks incoming fluid flow.
Figure 45
Fluid entering the flow sensor pushes the injected bubble through the glass capillary
tube. The tube has an end-to-end volume of approximately 1.2 ml. An array of 8 optical
sensors located along the glass tube continuously tracks the bubble position for flow
measurement. Every time the bubble crosses the 8th optical sensor, a new bubble is
injected into the glass tube.
Appendix B # Page 60
INFUTEST SOLO OPERATING MANUAL
Volume of the glass capillary tube between adjacent optical sensors is calibrated at the
factory to within +/- 0.0000052 ml using a precision microsyringe dispensing system.
These volume calibrations along with other flow sensor and pressure sensor calibrations
are programmed into the Solo’s EEPROM memory.
Flow measurement is based on a transit time principle. As described, volume of the
glass tube between optical sensors is known precisely. Flow is derived by measuring the
time required for the bubble to cross these calibrated volumes. Volume is derived by
summing the calibrated volumes incrementally as the bubble crosses them.
Note that the collection tank in the pneumatic feedback system is mostly filled with air.
Therefore, fluid draining from the Fluid Output is poorly correlated with fluid entering
the input.
B.3 Pressure Measurement System
During the Occlusion Pressure Test, the occluder valve shown in Figure 45 energizes
and blocks fluid flow downstream of the pressure transducer. The pressure transducer
senses the pressure developed by the infusion device under test, and resulting pressure
measurements are displayed on the LCD.
Appendix B # Page 61
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Appendix B # Page 62
INFUTEST SOLO OPERATING MANUAL
APPENDIX C. CALIBRATION
C.1 Annual Calibration
Calibration of Solo by a Datrend Authorized Service facility is recommended on an
annual basis, and is required to extend the product warranty. The basic one (1) year
warranty can be extended to a maximum of five (5) years provided that annual
calibration is performed by a Datrend Authorized Service Center on an annual basis.
Refer to the Calibration Decal applied to the rear panel of the unit to determine
calibration status of your Solo.
Solo may only be CALIBRATED with specialized equipment and software found at
Datrend authorized service facilities. This equipment allows proper adjustment of the
internal electronics of the instrument.
Independent service centers may be able to perform a performance VERIFICATION;
however, they will NOT be able to perform repairs or adjustments to your Solo.
When calibration is due, contact Datrend Customer Service at 1-800-667-6557
(604-291-7747 outside of North America) about the authorized service facility nearest
your location and to obtain an RMA number.
Datrend Systems Inc.
#130 - 4020 Viking Way
Richmond, BC • CANADA. • V6V 2L4
Tel 604.291.7747 or 800.667.6557 • Fax 604.294.2355
e-mail customerservice@datrend.com
www.datrend.com
Appendix C # Page 63
INFUTEST SOLO OPERATING MANUAL
C.2 Calibration Verification
C.2.1 Pressure Accuracy Verification - Field Test
Solo’s pressure measurement system may be verified in the field by running an
Occlusion Pressure Test with an external pressure gauge connected via a tee to
the input. Validity of the pressure calibration verification will be dependant on
the accuracy and traceability of the external gauge used.
C.2.2 Flow Accuracy Verification - Field Test
The flow measurement system CANNOT be verified in the field using
infusion devices intended for medical applications. Such device lack the
stability and repeatability required for checking calibration.
The flow measurement system CANNOT be verified in the field using
measuring devices connected to the Output.
The flow measuring system may be verified using a precision syringe pump of
laboratory grade which has itself been calibrated using a gravimetric test protocol
and apparatus similar to that defined in IEC 601-2-24 Part 2, or equivalently,
ANSI Standard ID-26. We recommend Harvard Apparatus model 22 or model
44 with a precision-ground glass syringe or glass microsyringe having the
minimum volume necessary for the verification, depending on the verification
rates of interest (Harvard Apparatus USA, Holliston MASS, (800)-272-2775;
ENGLAND Edenbridge, Kent, 44-1732-864001; www.harvardapparatus.com).
For verification rates in the range 50 to 200 ml/hr, B-D Yale #2313 (precision
20 cc) is recommended.
If the test pump is a Harvard model 22 equipped with B-D Yale #2313, the test
pump should be tested gravimetrically at 50 ml/hr and 200 ml/hr prior to each
verification run on Solo. The pump should be allowed to dispense 1 ml at the
selected rate before any test measurement is started. Use an analytical balance to
measure the mass of distilled water effused from the test pump over 10 minutes
at 50 ml/hr and over 4 minutes at 200 ml/hr. Calculate the average rate in
ml/hr by dividing the mass by the specific gravity (0.9973 gm/ml at 24EC), and
then by the test time. Compare this result to Solo’s Average Flow from a
Rate+Volume Test of 10 minute (50 ml/hr) or 4 minute (200 ml/hr) duration.
Three runs, consisting of a gravimetric measurement followed by the Solo
Rate+Volume Test, should be conducted to obtain repeatability of both the
standard (gravimetric) and Solo.
Appendix C # Page 64