Civco Astra Tee Series User manual

Operator's Manual
Transesophageal Probe Reprocessor
Manufactured by:
CIVCOMedical Solutions
102 First Street South
Kalona, IA 52247 USA
319.248.6757 / 800.445.6741
WWW.CIVCO.COM
Copyright © 2020 All Rights Reserved.
ASTRA TEE and Glute-Out are registered trademarks of CIVCO Medical Solutions.
All other trademarks are property of their respective owners.
Printed in the USA.

Table of Contents
SECTION 1: ASTRA TEE SYSTEM 2
A. INSTRUCTION MANUAL 2
B. OVERVIEW OF ASTRA MODELS 2
C. WARNINGS & CAUTIONS 3
D. EMERGENCY SHUT DOWN PROCEDURE 4
E. SYMBOLS 4
F. LABELS ON THE DEVICE 5
G. INTENDED USE 5
H. USER QUALIFICATIONS/SAFETY 5
I. DEVICE OVERVIEW 6
SECTION 2: OPERATING INSTRUCTIONS 8
A. DISINFECTION PROCESS OVERVIEW 8
B. PREPARING THE SYSTEM 8
C. LOADING DISINFECTION CONSUMABLES - FOR ASTRA ULTRA MODELS ONLY 10
D. REPLACING HLD BOTTLE 14
E. ROUTINE OPERATION OF THE SYSTEM 19
F. RETRIEVING CYCLE HISTORY 24
G. DOWNLOADING AND ERASING CYCLE HISTORY 26
SECTION 3: ROUTINE MAINTENANCE 27
A. MAINTENANCE AND INSPECTION 27
B. DAILY CHECK / PRIOR TO OPERATION 27
C. SIX MONTHS MAINTENANCE 28
1. REPLACING WATER FILTER 28
2. WATER INLET LINE DISINFECTION (WILD CYCLE) 30
3. REPLACING AIR FILTER 33
SECTION 4: USER CONFIGURABLE SETTINGS 35
A. SETTING DATE & TIME 35
B. CHANGING HIGH-LEVEL DISINFECTANT TYPE 35
SECTION 5: SERVICE AND WARRANTY 37
A. WARRANTY INFORMATION 37
B. TECHNICAL SUPPORT / SERVICE 37
APPENDIX A: TROUBLESHOOTING GUIDE 38
APPENDIX B: ASTRA® SYSTEM ERROR CODES 39
APPENDIX C: SITE REQUIREMENTS & SPECIFICATIONS 40
APPENDIX D: APPROVED PROBES 41
APPENDIX E: EMC COMPLIANCE INFORMATION 42
APPENDIX F: SOFTWARE LICENSING 43
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SECTION 1: ASTRA TEE SYSTEM
A. INSTRUCTION MANUAL
This Operator’s Manual contains important information for initial setup, maintenance, and safe and effective
operation of this device. Review this manual before use. For device installation instructions, refer to the Installation
Manual. Keep this manual and other instructions in a safe and accessible location. Contact CIVCO Medical Solutions
with any questions or comments.
B. OVERVIEW OF ASTRA MODELS
The ASTRAautomated high-level disinfection probe reprocessor is available in three unique models. The
ASTRAmodels provide various data tracking and storage capabilities. The capabilities of each ASTRA model are
described below. Throughout the ASTRAOperator's Manual, instructions may apply to all three ASTRAmodels or
just one model.
Please contact CIVCOMedical Solutions if you have any questions about your ASTRA or desire information to
change from one model to another.
Instructions that apply only to users with the ASTRAULTRA model will be highlighted in gray and may be skipped by
users of the ASTRAPLUS and ASTRABASEmodels.
ASTRA ULTRA model (new):
lProvides full data tracking, storage, and quality control of disinfection consumables.
lRequires use of high-level disinfectant and test strip bottles approved for use with ASTRA with unique
CIVCObarcode, available only through CIVCO.
HLD Bottle with CIVCO Barcode Test Strip Bottle with CIVCO Barcode
ASTRA PLUS model (new):
lProvides partial data tracking, storage, and quality control of disinfection consumables.
lMay be used with any high-level disinfectant and test strip bottles approved for use with ASTRA.
ASTRA Base model (legacy):
lStandard ASTRA unit.
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ASTRA
ULTRA
ASTRA
PLUS
ASTRA
BASE
Sourcing of HLD and Test Strips CIVCO Any
Vendor
Any
Vendor
Additional HLD and Test Strip Tracking Features
Logs Lot # and Manufacturer's Expiration Date √ √ -
Prevents Use Beyond Manufacturer's Expiration Date √ √ -
Confirms Test Strip Compatible with HLDSolution √ √ -
Provides MRC Test Countdown Timer on screen display during daily cycles √ √ -
Mandates Quality Control for Newly Opened Test Strip Bottles and Logs Results √- -
Logs Date Test Strip Bottles Opened √- -
Prevents Use Beyond Test Strip Open Shelf-Life √- -
C. WARNINGS & CAUTIONS
CAUTION:
lRead the entire manual before using the device.
lThere are no user serviceable parts inside. Shock hazard may be present behind access panel. Panel removal
should be performed only by qualified service personnel.
lDo not use this system until it has been properly installed.
lUse the device only for the intended use as described in this manual.
lDo not operate the device if it is not working properly or if any part of the device has been dropped or
damaged.
lFor use only with CIVCO Medical Solutions approved high-level disinfectants.
lConnect the system to a hospital grade GFCI receptacle only. Confirm GFCI outlet is properly grounded prior to
use. The GFCI outlet must be tested on a regular basis per the GFCI manufacturer’s recommendation.
lDo not attempt to neutralize the high-level disinfectant while inside the disinfection chamber.
lDo not operate the system if fluid leakage is present - contact CIVCO Medical Solutions.
lThis device is not intended to augment or replace proper pre-cleaning prior to disinfection. If you are unclear
as to the proper pre-cleaning method for your probe, please contact the probe manufacturer for their
recommended procedure.
lFailure to check with the probe manufacturer to determine soaking depth can result in a damaged probe.
lA Water Inlet Line Disinfection (WILD) cycle must be conducted after installing a new water filter. Refer to
Section 3.
lThe high-level disinfectant must be replaced if the minimum required concentration (MRC) test fails or the
reuse life is reached in accordance with the HLD manufacturer’s instructions for use (IFU). Failure to do so can
result in improperly disinfected probes.
lDo not use abrasive cleaning materials, solvents, or alcohol to clean the device.
lAvoid using Sani-Cloth® AF3 wipes to clean unit. It contains an ingredient known to damage the unit.
lDo not pour any items directly into disinfection chamber.
lDo not use this device for any purpose other than its intended use.
lIf you notice any unexplained changes in the performance of the device, or it is making unusual sounds,
contact CIVCO Medical Solutions.
lTip Hazard – Do not use the system without supplied wall bracket.
lDetermine that the subject probe is not damaged and in good working condition in accordance with
manufacturer’s recommendations before using in the ASTRA TEE system.
lWARNING: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 12 inches (30 cm) to any part of the ASTRA unit, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
lCaution: Exercise care when handling HLD bottle to avoid unnecessary exposure and contact with skin and
eyes. Refer to HLD MSDS for further detail.
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NOTE:
The emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required), this equipment
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measure, such as relocating or
re-orienting the equipment.
NOTE: The ASTRA system is not designed or intended to store Patient Health
Information (PHI).
CAUTION:
Hot Surface
When cabinet door is opened, use caution when removing and installing High-
Level Disinfectant (HLD) bottles. The HLD warmer plate surface temperature
may reach 161°F (72°C).
D. EMERGENCY SHUT DOWN PROCEDURE
1. Turn off the main power switch located on the right side of the device.
2. Turn off water or disconnect incoming water to device.
CAUTION: Any probes in the device during emergency shut down will not be disinfected.
E. SYMBOLS
Symbol Description Symbol Description
CAUTION WARNING: Electricity
Manufacturer CAUTION: Hot Surface
Consult Instructions for Use NOTE
Catalog Number Serial Number
Lot / Batch Number Quantity
On (Supply) Off (Supply)
Fuse
Figure 1
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F. LABELS ON THE DEVICE
G. INTENDED USE
The ASTRA TEE automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal
ultrasound probes using FDA cleared and CIVCO Medical Solutions approved high-level liquid disinfectants.
H. USER QUALIFICATIONS/SAFETY
The ASTRA TEE Transesophageal Probe Reprocessor is intended for use in non-sterile healthcare settings by
trained, qualified healthcare personnel.
The operator of this equipment must be sufficiently trained in the use of this device and reprocessing of ultrasound
probes. The healthcare facility should ensure regular training of all personnel concerned with the operation and
maintenance of the equipment, including emergency procedures for any toxic, flammable, explosive or pathogenic
material released into the environment. Records of attendance at training must be maintained, and evidence of
understanding demonstrated. Thoroughly review and understand the following items prior to using this device:
CAUTION: Ensure proper use of Personal Protective Equipment to minimize exposure to
chemicals and infectious materials as defined by HLD manufacturer and facility
procedures.
CAUTION:
Operators who exhibit symptoms of an allergic reaction or sensitivity to the
reprocessing chemicals should not operate this equipment. Before handling the
high-level disinfectant solution, carefully read the manufacturer’s instructions
for use and the material safety data sheet (MSDS).
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I. DEVICE OVERVIEW
Figure 2
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Figure 3
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SECTION 2: OPERATING INSTRUCTIONS
A. DISINFECTION PROCESS OVERVIEW
General flow of reprocessing steps of probe(s) using the ASTRA TEE automated reprocessor:
B. PREPARING THE SYSTEM
Prior to use:
lEnsure water supply and drain lines are properly connected.
lEnsure the water connection is turned on and there are no leaks.
lEnsure adequate space is available to allow safe access to controls and proper ventilation of the device. See
APPENDIX C for detailed requirements.
CAUTION:
Use of the supplied power cord is required to maintain proper grounding and
safe operation of the device. Use of power cords not supplied by CIVCO Medical
Solutions may affect the safety and performance of this device.
1. CIVCO Medical Solutions currently approves the following FDA cleared HLD’s for use with the ASTRA TEE:
lMetricide™ OPA
lCidex® OPA
lRevital-Ox® Resert® HLD
lRevital-Ox® Resert® HLD-Chemosterilant
System Interface Nomenclature HLDName Brand Region
HLDType OPA Metricide™ OPA United States
HLD Type OPA Cidex® OPA United States, Canada
HLD Type Resert Revital-Ox® Resert® HLD United States
HLDType CanadaResert Revital-Ox® Resert® HLD-Chemosterilant Canada
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2. Operator must confirm that the subject probe meets the following conditions:
lSubject probe is not damaged and in good working condition.
lSubject probe is approved by probe manufacturer for use with selected HLD.
lSubject probe has been approved by CIVCO Medical Solutions for use within the ASTRA TEE
system. See APPENDIX D.
3. Probe Identification:
Determine which method will be used for probe identification, there are two methods that can be used to
identify probes which are processed using this device:
lUse of existing manufacturer’s probe serial number barcode.
lUse of CIVCO Medical Solutions supplied unique QR codes (recommended).
If the existing probe serial number barcode will be used, no additional identification preparation is required.
For the use of CIVCO Medical Solutions supplied QR codes, the following steps are required:
lLocate the sheet of the Probe QR codes provided with the device. If needed, additional sheets are
available from CIVCO Medical Solutions.
lQR codes are unique. Apply one QR code decal to the connector area of the probe and ensure it does
not interfere with any other identifying labeling. The QR code decals are not designed to be applied to
an area on the probe that will be submersed in the disinfection chamber.
lRecord the probe manufacturer serial number for each QR code and keep for your records.
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C. LOADING DISINFECTION CONSUMABLES - FOR ASTRA ULTRA
MODELS ONLY
Loading Qualified Test Strip Bottle - For ASTRAULTRA models only
Before running a disinfection cycle, a qualified test strip bottle must be loaded to be used in the cycle. ASTRAcan
store information for up to 64 test strip bottles.
Qualified test strip bottle must satisfy the following:
lMatch HLDtype used
lExpiration date has not passed
lPass quality control test
NOTE:
The quality control test must be performed outside of the ASTRAsystem.
Verification results are entered into the ASTRAsystem for traceability and can
be viewed in the ASTRAcycle log.
1. Press the MENU button on the keypad and select Load Qualified Test Strip Bottle. Display will read:
2. Press ENTER and the display will read:
3. Scan Operator ID barcode. The display will read:
4. Scan HLD bottle. The display will read:
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5. Scan test strip bottle. The display will prompt user to enter the test strip bottle open date. The Current Date
will be displayed as default. If the test strip bottle is already open, a date in the past may be entered. Using
arrow keys, set to desired time/date and press ENTERto confirm selections. The display will read:
NOTE: A date in the future cannot be entered.
6. After selecting MENU, the display will prompt the user to enter the HLD solution temperature used to
perform the quality control test. Using the left or right arrows, increase or decrease the temperature,
respectively, in 0.1°F increments. Press ENTER to accept the value.
NOTE: One Celsius increment occurs with every two 0.1°F increments.
The default temperature is 68.0°F/20.0°C
7. After selecting ENTER, the display will prompt the user to enter the Positive Quality Control test results.
Press PASS or FAIL using the corresponding arrows. The display will read:
8. If PASSis selected, the display will prompt the user to enter the Negative Quality Control test results. Press
PASS or FAIL using the corresponding arrows. The display will read:
9. If FAILis selected for either the Positive or Negative Control tests, the process must restart and screen will
display:
10. If PASSis selected for both the Positive and Negative Control tests, the screen will display:
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Confirming Presence of Qualified Test Strip Bottle - For ASTRAULTRA models only
At any point, the user may confirm a qualified test strip bottle has been previously loaded into the ASTRAsystem.
1. Press the MENU button on the keypad and scroll through the menu options using the arrow keys until the
display reads:
2. Press ENTER and the display will read:
3. Scan test strip bottle. If bottle has previously been qualified and loaded, the display will read:
4. If test strip bottle has not previously been qualified, display will read:
NOTE: Refer to Section 2.C "Loading Qualified Test Strip Bottle."
5. If the bottle has previously been qualified and loaded but is now expired, the display will read:
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When to Qualify a New Test Strip Bottle - For ASTRAULTRA models only
1. The ASTRA TEE automatically keeps track of the expiration and open bottle life of each test strip bottle and
prompts the user when a bottle has expired. The display will blink between:
and
2. Pressing MENU at this time acknowledges the bottle expiration and returns the user to the Start Menu to
run a cycle. The display will read:
3. When there is only one remaining test strip bottle, seven days prior to its expiration, the display will alert
you to load a new test strip bottle. The display will blink between:
and
4. Pressing MENU at this time will initiate the loading qualified test strip bottle process. Refer to Section 2.C,
"Loading Qualified Test Strip Bottle". Pressing ENTER at this time acknowledges the upcoming expiration and
begins the process of starting a disinfection cycle.
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5. The ASTRATEE will notify the operator when the last remaining bottle has expired. If no additional qualified
test strip bottles have been loaded in the system, the display will blink between:
and
6. Pressing ENTER at this time will initiate the loading qualified test strip bottle process. Refer to Section 2.C,
"Loading Qualified Test Strip Bottle."
D. REPLACING HLD BOTTLE
When to Replace Bottle:
Under normal operations, the HLD bottle will be required to be changed every 14 or 21 days (depending on HLD
type). The HLD bottle will also require changing should the MRC test fail at any time, at the completion of a WILD
cycle or should the user initiate an HLD bottle replacement via the MENU.
The ASTRA TEE automatically keeps track of the reuse period of the HLD bottle and prompts the user to change the
bottle towards the end of the 14th or 21st day (depending on HLD type) reuse period. The bottle used for
disinfection in the ASTRATEE should remain in the system and not be moved for other purposes. Do not remove
the existing bottle before the end of its reuse period unless a new, unopened bottle is available to replace it.
1. On the last day of the 14 or 21-day (depending on HLD type) reuse period (24 hours before expiration), the
ASTRA TEE reminds the user that the bottle reuse is about to expire. At this time, the screen will blink
between:
and
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You may still use the disinfectant on the 14th or 21st day (depending on HLD type) by pressing the ENTER
button to start a normal disinfection cycle. Pressing MENU will initiate a bottle replacement process – refer
to “How to Replace HLD Bottle” section. It is recommended the disinfectant be changed at the end of the
14th or 21st day (depending on HLD type). If not replaced by the end of the 14th or 21st day (depending on
HLD type), the system will force the user to change the disinfectant and the display will blink between:
and
Pressing ENTER at this time will initiate a bottle replacement process – refer to “How to Replace HLD Bottle”
section.
2. Should the MRC test strip fail and the user has pressed the FAIL arrow on the display, HLD is pumped back to
the bottle and the display will read:
Followed by:
Once the probes are removed from the system, the system will initiate a bottle replacement process – refer
to “How to Replace HLD Bottle” section.
3. User initiates bottle replacement by pressing the MENU button on the keypad during idle mode. Using the
right arrow on the keypad, scroll through the menu options until it displays:
Pressing ENTER at this time will initiate a bottle replacement process – refer to “How to Replace HLD Bottle”
section.
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How to Replace HLD Bottle:
Prior to replacing HLD bottle, the operator must be trained on this procedure. When a HLD bottle replacement has
been selected the following process is to be followed to replace the HLD bottle.
CAUTION:
Ensure proper use of Personal Protective Equipment to minimize exposure to
chemicals and infectious materials as defined by HLD manufacturer and facility
procedures.
1. Barcode scanner will illuminate and display will read:
2. Scan Operator ID barcode and display will read:
3. Open cabinet door.
CAUTION:
Hot Surface
When cabinet door is open, use caution when removing and installing High-
Level Disinfectant (HLD) bottles. The HLD warmer plate surface temperature
may reach 195°F (91°C).
4. Release the two quick-disconnect fittings and remove existing HLD bottle. (See Figure 4). The quick
disconnect fittings are self-sealing but a few drops may be released. Wipe these up using a paper towel.
Place the used HLD bottle in a sink.
CAUTION: Exercise care when handling the HLDbottle to avoid unnecessary exposure and
contact with skin and eyes. Refer to HLDMSDSfor further detail.
5. Removing HLD bottle activates scanner and the display will read:
NOTE: Use only HLD types approved by CIVCO Medical Solutions. System will not allow
use of unapproved HLD types. Display will read “Invalid Barcode”.
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6. Prior to opening the new bottle of HLD or removing the seal, first verify the expiration date on the new
bottle is at least 14 or 21 days away (depending on HLD type). Then, using a permanent marker, write the
date opened on the bottle, scan the bottle and place beside the used HLDbottle.
NOTE:
A fresh HLD bottle stored in a cool location may take an hour or more to come
up to temperature. To speed up the warming process, place the unopened
bottle in a container of warm water. It is suggested to warm the solutions to the
temperatures in the table below to limit the amount of warming time within the
system.
Metricide™ OPA/Cidex® OPA Minimum 86°F or 30°C
Maximum 90°F or 32°C Soak Time: 5 minutes
Revital-Ox® Resert® HLD Minimum 80°F or 27°C Soak Time: 8 minutes
Revital-Ox® Resert® HLD-Chemosterilant Maximum 85°F or 29°C Soak Time: 5 minutes
NOTE:
The ASTRA TEE monitors HLD solution temperature both during the WILDcycle
(Refer to Section 3) and during standard probe disinfection cycles.
Temperatures during these cycles meet or exceed the minimum temperature
requirements as specified by the HLD manufacturers. If the temperature falls
below manufacturer's minimum requirements, the system will produce and
error and will indicate the error on the system display and within the cycle log.
7. Place new bottle in sink next to old bottle and transfer HLD Cap Assembly from the used bottle to the new
bottle.
NOTE: Do NOT discard the HLD Cap Assembly (see Figure 4).
8. Scan the new bottle and display reads:
9. Place the HLD bottle into the lower chamber on warmer plate (see Figure 3). Push the HLD Cap Assembly
quick disconnect fittings firmly into the matching fittings in the cabinet. Make sure that the quick disconnect
fittings snap into place.
NOTE: Press the quick release top tabs to unlock the connectors prior to snapping
the quick connector fittings back into place. Failure to properly connect these
fittings will result in a failed disinfection cycle.
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10. Close cabinet door. An internal system sensor will confirm that the bottle is in place and the display will
read:
and
11. Safely dispose used HLD. CIVCO Medical Solutions manufactures Glute-Out® Neutralizer, which is specifically
designed for use with OPA based disinfectants. Use of these products will allow for safe HLD disposal in a
drain. Always refer to HLD manufacturer instructions for additional information regarding HLD and HLD
container disposal.
NOTE:
To improve the process of adding the Glute-Out to the HLD bottle add a small
amount of water (approx. one tablespoon) to the Glute-Out, close cap and shake
for 5 seconds to create a suspension that can then be easily poured into the HLD
bottle.
CAUTION: Do NOT pour neutralizers directly into the ASTRA TEE system. Refer to the
neutralizer instructions for proper use.
NOTE: Follow state, local, and facility disposal regulations for used HLD and HLD
container.
NOTE:
A fresh HLD bottle stored in a cool location may take an hour or more to come
up to temperature. To speed up the warming process, place the unopened
bottle in a container of warm water and allow to sit until the temperature is
increased to approximately 88°F (for OPA) and 78°F (for Resert).
NOTE: Use only HLD types approved by CIVCO Medical Solutions. System will not allow
use of unapproved HLD types. Display will read: “Invalid Barcode”.
Figure 4
HLDCap Assembly
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E. ROUTINE OPERATION OF THE SYSTEM
Some steps include instructions for ASTRAULTRAand ASTRAPLUS models, but do not apply the
ASTRABASEmodel. Please contact CIVCOMedical Solutions for information on upgrading. Refer to Section 1.B
"Overview of ASTRAmodels."
NOTE:
The ASTRA TEE should be left on at all times to maintain the appropriate HLD
temperature. Failure to do so can result in a delay while HLD is brought up to
the minimum required temperature. The device will confirm the presence of
an HLD bottle and that the appropriate temperature is reached.
CAUTION: Any probe in the system during power up must be treated as not disinfected
and should go through the entire reprocessing cycle including pre-cleaning.
1. When ready, the display will read:
Followed by:
2. Pressing ENTER will activate the non-laser scanner and the display will read:
NOTE: If the HLD bottle is not at the appropriate temperature, the ASTRA TEE will
display the following until the bottle has reached appropriate temperature.
Followed by:
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