Allergen Mixing Assistant User Manual
Contents
1. the system health and function e PULSING BLUE Standby Mode e BLUE Nominal Function Temperature Below 8 C e YELLOW Normal Function Temperature Above 8 C e RED Normal Function Temperature Above 8 C for more than 45 Minutes e PULSING YELLOW Empty Condensate Bottle Reminder e PULSING PURPLE Defrost Mode e FLASHING RED System Error Contact Support Accessories Vial Adapters Vial adapters may be needed if your clinic uses any small top extract concentrate vials such as those found on some 10 mL vials Snap the provided vial adapters onto the small top vial to convert it to a standard size vial before loading into the AMA Syringe Keys Syringe Keys are hand held tools designed to help the user to obtain rapid accurate and precise volumetric draws from vials containing allergenic extracts While the Syringe Keys are not required to use the AMA we strongly recommend incorporating them in to your mixing routine for accurate repeatable dosing Please see Using Syringe Keys on Page 7 for more information Unpacking amp Setup To remove the vial storage head from the box set the box on its side Slide the vial storage head out of the box using the handles and place it on the floor To remove the refrigeration base grasp underneath the top of the black bearing plate and lift straight up out of the box and place it on the countertop or cart in your mixing area The foam around the top of th2. ALLERGEN MIXING ASSISTANT User Manual SUaGABSE i a Be l 9495 SW Locust Street Suite E Portland OR 97223 503 379 0110 Fax 503 715 1378 www xtractsolutions com SM026R2 Welcome to Xtract Solutions Thank you for purchasing the Allergen Mixing Assistant AMA from Xtract Solutions Please review the instructions in this user manual before unpacking and set up Should you have any questions or require support at any point please call our customer support group at 503 379 0110 ext 2003 or email us at support xtractsolutions com Table of Contents Main Components and Features Accessories Unpacking Your AMA Water Bottle and Work Surface Powering Up Stocking Your AMA Mixing a Patient Vial Using the Syringe Keys Powering Down Your AMA Cleaning Your AMA o o o N A a a a A A W Emptying the Water Bottle Product Disclaimer The Allergen Mixing Assistant AMA and Syringe Keys are tools to assist mixing personnel with extract vial preparation Proper use of these products is fully compatible with allergen immunotherapy extract preparation guidelines established by the Joint Council of Allergy Asthma and Immunology Xtract Solutions does not make any recommendations related to source or type of extract immunotherapy prescriptions dosing schedules dilution sets labeling expiration dates or any other standard operating procedures followed by mixing personnel in your clinic We encourage y
3. Guide For your 10 mL vials snap the Vial Adapters onto the cap and then snap the whole as sembly into the Vial Guides Rotate the vials to ensure that the label is facing outwards caution ZA Be sure to double check that all the labels on the inside and outside of the refrigerator doors match Once you have completely stocked your AMA with vials close all the doors and allow several hours for the vials to cool down to 2 8 C Mixing a Patient Vial 1 Place the patient s formula in a visible location 6 Repeat Step 5 for each extract vial in the formula 2 Place the patient s vial and mixing syringes on the counter or work surface 3 Group the prescribed drugs by opening the doors of the extract vials listed in the patient s formula 7 Draw up the dose required for first prescribed ex tract Use of the Syringe Keys is recommended 4 Wipe down all surfaces inside the vial storage door 8 Remove the syringe and dispense the dose into the using 70 isopropyl alcohol and proper aseptic tech patient vial nique per pharmaceutical preparation guidelines 5 Uncap a mixing syringe and slide it into the cylindri cal channel on the Vial Guide until it pierces the rubber septum of the extract vial 9 Close the door of the dispensed extract to verify that it has been added 10 Repeat Steps 7 9 until all drugs have been added to the patient vial 11 Mixing is now complete Label and make dilution s
4. an accessory to the 1 0 mL Terumo SurSaver and Optimix syringes DO NOT USE SYRINGE KEYS WITH ANY OTHER BRAND OR TYPE OF SYRINGE 7 Powering Down caution ZO Always use the following procedures to power down your AMA Do not push the Master Switch or unplug the AMA while it is running Damage to the refrigeration system may result 1 Only power down the unit to move or clean Press the front panel button once 3 The display will read SHUTDOWN REQUEST CLICK TO CONFIRM 4 Press the front panel button once again to initiate shut down The display will read SHUTDOWN OK POWERING DOWN A chime plays when shutdown 5 The unit now in Stand By Mode To fully power down your AMA push the Master Switch in the back of the device 7 You can now unplug the unit to move or clean N Cleaning caution ZA Please do not attempt to clean the interior of the vial storage head while the AMA is powered on This may result in electrocution or damage to the device 1 Remove the rotating storage head on top of the AMA and place it on the counter and then remove the lid 2 Use an anti bacterial all purpose cleaner and a cloth or paper towels to wipe down all the surfaces on the inside of the rotating storage head 3 Let the inside dry before placing the head back on the refrigeration unit Emptying the Water Bottle 1 Press the gray button to remove the connector and bottle from the nozzle on the AMA 2 U
5. e refrig eration base Is packed tightly into the box We recommend another person holds the box down while you pull the base out of the box Remove the packaging materials from the cooling element on top of the refrigeration base and set aside Re move the foam protecting the cooling element by pulling down on the colored tape After removing the packaging materials please inspect the equipment for concealed shipping damage Please retain the packag ing in the event you need to transport or store the AMA Once all packaging materials have been removed lift the vial storage head using the handles and place it carefully on top of the refrigeration base Rotate the head several times to ensure it spins freely If the head does not spin freely please check to make sure all the ball bearings six are snapped into place Please remember to complete and return your product acceptance form via fax to 503 715 1378 Water Bottle and Work Surface If not already attached connect the condensate water bottle to the nozzle on the back of your AMA by pushing in until you hear a click To install the work surface line up the thumb screws on the end of the prongs with the holes on the side of the refrigeration base Pull the thumb screws out slightly and Powering Up 1 Remove the power cord from the box and plug the lead into the back of the unit and the plug into a grounded 3 prong wall outlet or extension cord 2 Turn on the master sw
6. et as per your current clinic practices Using the Syringe Keys For Use with Prescription Only NOTE The Syringe Keys are not required to be used with 6 Repeat this step for each extract vial in the formula the AMA However we strongly recommend using them 7 Draw the extract into the syringe barrel and then to minimize dosing errors place the appropriate Syringe Key between the thumb rest on the end of the plunger and the finger 1 Please select the Syringe Key or Keys that corre flange Brace the Vial Guide with your other hand as spond to the doses you plan to draw needed You can use the edge on the end of the Key 2 Place the Key or Keys patient s vial and syringes on to draw out the plunger Step 2 the counter or work surface 8 Press the thumb rest back until the Key limits further 3 Disinfect keys with 70 isopropyl alcohol prior to travel of the plunger Step 3 use 9 You will now have the correct dose 4 Flip down the doors of the extract vials listed inthe 10 Remove the syringe and dispense the dose into the patient s formula patient s vial 5 Uncap a mixing syringe and slide it into the cylindri 11 Repeat these steps until the patient s formula is cal channel on the Vial Guide until it pierces the rub complete Label the vial per your clinic s guidelines ber septum of the extract vial Step 1 and place in the refrigerator Syringe Keys are Class II medical devices cleared by the FDA to only be used as
7. itch on the back of your AMA Verify that top two green power status indicators are illuminated 3 After a brief self test the display window on the front of your AMA will now read XTRACT SOLUTIONS AMA CX Unit is now in Standby Mode 4 Press the front panel button to turn on the refrigera tion unit and the display window will read PRE COOLING and percentage to completion NOTE Depending on shipping and environmental conditions it may take up to 2 hours for the internal temperature to stabilize within 2 8 C It is recom mended that you wait until the AMA s internal tem perature has reached 2 8 C before loading the device 3 with extract vials 3 If the temperature has not fallen below 8 C af ter 2 hours please contact Customer Support 5 Once the unit has competed the Pre Cooling routine it will begin to display the internal temperature Once the temperature drops below 8 C it is safe to stock the unit with extracts Stocking Your AMA Once the AMA has reached the 2 8 C temperature range flip down all the refrigerator doors on your AMA Wipe down the entire surface of the Vial Guide with 70 isopropyl alcohol and allow to dry prior to loading the extract vials We recommend using cotton swabs or wipes instead of cotton balls Select the extract vials that correspond to the labels on the outside and inside of the doors flip them over so the tops are facing down and snap the vial crimp into the notch on the Vial
8. nscrew the cap and pour the water into the sink 3 Reattach the connector and push hard onto the noz zle into you hear a click NOTE Double check to make sure the button on the connector is not depressed If the bottle is not connect ed properly water will pool inside the storage head and not drain properly Problems and Troubleshooting If any of the following problems occur please contact Customer Support at 503 379 0110 ext 2003 or at support xtractsolutions com immediately e I have plugged in my AMA and flipped on the Master Switch in the back and the green lights have not come on e The green lights have come on but the display on the front of my AMA is blank e Display reads SENSORS MISSING or other error e Display reads TEMP CRITICAL RESETTING First try the solutions listed here before calling Customer Support Water is not draining properly inside the bottle storage head Your AMA may not be level on top of your counter or cart Take the storage head off tip the refrigeration base to the side and raise the feet on the left side by screwing them out 1 2 turns Also check to make sure the con densate water bottle is fully attached to the nozzle in the The storage head is not rotating properly Inspect the alignment to make sure it is not off center Also check to see if all the ball bearings are in the retain er The temperature is out of the 2 8 C range If the AMA has been in use with the ref
9. ou to continue to follow your clinic s guidelines unless otherwise directed by the physician or governing bodies Important Safety Instructions Your safety and the safety of others is very important Please always read and obey all safety messages To reduce the risk of electric shock or injury when using your AMA follow these basic precautions Plug the power cord into a grounded 3 prong outlet either in the wall or in an extension cord Disconnect power before cleaning or maintenance Use two or more people to move and install the AMA Failure to do so can result in back or other injury Install the AMA on a sturdy surface countertop or medical cart that can support at least 80 Ibs The Syringe Keys included with your AMA are Class II medical devices cleared by the FDA to only be used as an accessory to the 1 0 mL Terumo SurSaver and Optimix syringes Do not use Syringe Keys with any other brand or type of syringe Main Components and Features Refrigeration Base Optional Work Surface oN i gt Sre e r cmt as f 4 ae a e b d f i tre rt en s Vial Storage Head Condensate Extract Water Bottle Category Extract Symbology Specific Aadi m 010E Extract EDUGA Exterior Label Temperature Display Interface 1 Panel Button Press this button to turn the refrigeration system on off 2 Status Indicator Ring The status indicator ring glows various colors to indicate
10. rigerator doors down temperature may go above 8 C Please close all the refrigerator doors if you have not done so already and the temperature should return to 2 8 C Also check to ensure the lid is on tightly and the bottle storage head is aligned and rotating correctly When the doors are flipped down the vials are leaking This could be an effect of coring caused by repeatedly piercing the rubber septum in the same location Due to variations between extract manufacturers some brands of extracts are more prone to coring than others The Vial Guides in which the vials are stored are designed with a slight offset so as to not pierce the septum dead center Please rotate the vials within the Vial Guide periodically to ensure that you are piercing different parts of the sep tum s surface We also recommend using a new syringe every time you enter the vial Repeated use of the same syringe dulls the needle and could lead to excessive cor ing
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