Avoset Infusion Pump User Guide
- June 12, 2024
- Avoset
Table of Contents
Avoset Infusion Pump
Safety Quick Guide
15132-048-1014 | Rev2.0Ver02 / 02.2023
Eitan Medical LTD
29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529 ISRAEL +972-73-238-8888
Toll-free number +1.877.541.9944
support@eitanmedical.com
Technical Assistance
For technical questions and troubleshooting assistance please contact your
local agent/distributor, or contact us via email:
support@eitanmedical.com.
Serious Incident Reporting
Any serious incident that has occurred in relation to the device should be
reported to complaints@eitanmedical.com
and to the local competent authority.
Bluetooth License
Avoset is qualified under Bluetooth SIG and has licensee right to use the
Bluetooth trademarks.
Purpose
This Quick Guide provides important guidelines to help you use your Avoset
Infusion Pump safely and effectively. Further technical information on Avoset
infusion pump and accessories is available in the Avoset Infusion Pump User
Manual, contact your service provider for support. The safety information is
grouped in functional categories and prioritized as follows:
| Category | Description |
|---|---|
| Warnings | Precautions and instructions which, if not followed, may result |
in personal injury.
Cautions| Instructions which, if not followed, may result in damage to
the equipment or to the quality of treatment.
Safety Guidelines
Getting Help
Child Safety
Warning: Keep used plastic containers and packaging out of the reach of children and pets. The administration set, infusion container and packaging contains small parts and may contain residual medication.
Avoid Deviation from Accuracy
Caution:
Avoid Exposure to Harmful Use Conditions
Caution:
Storage
Caution: Remove batteries for long storage: Do not keep the batteries inside the pump when storing the pump for a long period of time (over 6 months).
Pump Guidelines
When to Not Use the Pump
Warning:
Do Not Do the Following with the Pump
Warning:
Administration Set Guidelines
When to Not to Use an Administration Set
Warning:
Do Not Do the Following with an Administration
Set
Warning:
Caution: Do not pull or stretch the administration set tubing when the pump is in use.
Purpose
This Quick Guide provides important guidelines to help you use your Avoset
Infusion Pump safely and effectively. Further technical information on Avoset
infusion pump and accessories is available in the Avoset Infusion Pump User
Manual, contact your service provider for support. The safety information is
grouped in functional categories and prioritized as follows:
Warnings indicate precautions and instructions which, if not followed, may result in personal injury.
Cautions indicate instructions which, if not followed, may result in damage to the equipment or to the quality of treatment.
Safety Guidelines
Getting Help
If you have questions or concerns about your treatment, contact your physician or other healthcare professional who prescribed the treatment.
If you have questions or concerns about the equipment, contact:
- US toll-free: 1-833-771-2995
- see the website (eitanmedical.com) for other numbers that may be available
Child Safety
Warning
Keep used plastic containers and packaging out of the reach of children and
pets.
The administration set, infusion container and packaging contains small parts
and may contain residual medication.
Avoid Deviation from Accuracy
The Avoset infusion pump accuracy is of ± 5%
Caution
- Humidity: Do not use the pump in an environment with humidity above 90% or below 15%. You can find this information on a weather channel, website, or app.
- Altitude: Do not use the pump at very high altitudes (above 6096 meters / 20000 ft) or very low altitudes (below -381 meters / -1210 ft).
- Temperature: Do not use the pump in temperatures above 40°C / 104F or below 5°C /41F
- Placement: Do not place the pump more than 1 meter (3 ft) above or below the patient’s IV insertion point (see figure).
- Temperature Changes: Do not use the pump immediately after it was exposed to sudden extreme temperature changes (such as being brought into an air-conditioned room after being left in a hot car). Allow the pump to adjust to the new temperature before use for two hours.
- Plunger: Do not push or pull the syringe plunger after the administration set is attached to the pump.
Avoid Exposure to Harmful Use Conditions
Caution
Do not expose the pump to:
- direct sunlight and excessive heat (if you are outdoors, keep the pump shaded)
- steam and boiling water
- lint and dust
- submersion in water or other liquids
- MRI (magnetic resonance imaging) equipment. Remove the pump from the patient during MRI procedures, and keep it at a safe distance.
- therapeutic levels of ionizing radiation such as X-Ray, CT (Computed Topography), CAT (Computed Axial Tomography) scans, or radiation therapy
- portable RF (radio frequency)-enabled equipment (such as wifi routers or Bluetooth speakers) closer than 30 cm (12 in) from the pump
- flammable gas (including anesthetic mixtures or nitrous oxide)
Storage
Caution
Remove batteries for long storage: Do not keep the batteries inside the pump
when storing the pump for a long period of time (over 6 months).
Pump Guidelines
When to Not Use the Pump
Not
Do not use the pump or accessories (accessories including Avoset Cradle and
Cassette Lock) in these situations:
Warning
- Damage or Dropping: Do not use the pump or accessories if they were dropped or appear to be damaged until they have been inspected by a qualified technician.
- Interface Performance: Do not use the pump if its interface (including screen messages, audible signals, or physical key functions) does not perform as described in the provided manuals (for example, if there is no sound during an alarm, or if the screen light does not turn on when pressing a key).
- Training: Do not Operate the pump if you were not trained how to operate it.
Caution
Do not use the pump or accessories if any of the following occur:
- The screen does not light up.
- Any area of the screen is not visible, or there are stripes or black and white areas covering parts of the screen.
- When turning on the pump the green and red LED do not light momentarily.
- The Pump technical information does not show on the screen briefly when turning on the pump.
Do Not Do the Following with the Pump
Do not do the following things with the pump or accessories:
Warning
- Do not attempt to modify or disassemble the pump, accessories, administration sets, or the pump mechanism or housing.
- Do not use the pump, medication, or accessories provided by your service provider for anything other than the intended purpose. Misuse may lead to injury.
Administration Set Guidelines
When to Not to Use an Administration Set
Do not use an administration set in these situations:
Warning
- Usage Time: Do not use any administration set for longer than 96 hours. If your infusion is expected to exceed 96-hour, make sure to replace the disposable component on time.
- Damaged or Expired: Do not use an administration set if the set, its package, or its components are damaged or expired.
Do Not Do the Following with an Administration Set
Do not do the following things:
Warning
- Do not place the administration set on the floor, or anywhere it can accidentally be damaged, or pose a risk of strangulation or entanglement.
- Single-use only: Do not clean or sterilize Avoset administration sets for re-use. The sets are intended for single use.
- Do not release or attach an administration set from the pump or to the pump without first clamping the line.
Caution
Do not pull or stretch the administration set tubing when the pump is in
use.
Battery Guidelines
Installing and Replacing Batteries
Caution
- Inspect First: Do not insert batteries before visually inspecting the battery compartment for liquid or debris. Make sure it is dry and clear of debris (if necessary, clean the pump).
- Replace All Batteries at Once: Do not mix new batteries with old ones. Do not use different types of batteries together (for example, rechargeable with alkaline), as it may affect the pump’s performance.
- Do Not Open: Do not open the battery compartment unless you are changing batteries.
- Do Not Remove: Do not remove batteries while infusion is in progress.
- No Lithium Batteries: Do not use lithium batteries.
- Remove for Long Storage: Do not keep batteries inside the pump when storing the pump for a long period of time (over 6 months).
Setting up a Treatment Safely
Make sure you are aware of the following requirements when setting up a
treatment.
Warning
- Always keep a new set of AA batteries available as backup to prevent treatment interruption in case of power loss.
- Always insert a fresh set of batteries when starting a new infusion.
- If the treatment is for life-sustaining medication, always keep a second pump available as a backup. Pay attention to the treatment so that in the event of pump failure, you can switch to the backup pump, minimizing the interruption of medication delivery.
Disposal Guidelines
Warning
Do not dispose of the battery in or near fire.
Caution
- Dispose of the battery, pump, or any other electronic components according to your local laws. Contact your service provider if you are unsure.
- Dispose of used administration sets according to your local laws regarding medical waste. Used administration sets may contain residual medication..
- Dispose of all cleaning/disinfectant materials according to your local laws for infectious waste disposal.
Cleaning and Disinfecting
Between use on different patients, the pump and all of its components need to be first cleaned thoroughly and then disinfected thoroughly, per hospital/medical provider protocol for multiple patient use. If you wish to clean your pump, first contact your service provider to for proper training on the cleaning procedure.
Acceptable cleaning agents are:
- pump: 70% IPA (isopropyl alcohol)
- accessories: 70% IPA (isopropyl alcohol)
- see the website (eitanmedical.com), as this list may be updated with additional cleaning agents
Warning
Do not clean or disinfect unless:
- The pump is disconnected from the patient.
- The pump is disconnected from all sets and accessories.
- The pump is turned OFF.
Caution
Do not clean or disinfect the pump unless you are trained.
While cleaning or disinfecting:
- Do not clean, disinfect, or sterilize any part of the pump by autoclaving, or with ethylene oxide gas. Doing so may damage the pump and void the warranty. Disinfect only the external parts of the pump.
- Do not allow fluid (including cleaning agents) to enter the pump (including speaker holes, cassette socket, or battery compartment).
- Do not steam autoclave, ethylene oxide sterilize, or immerse any part of the pump in fluid.
- Do not use spray or aerosol cleaners.
- Dispose of all cleaning/disinfectant materials per regulations for infectious waste disposal.
Cleaning the Pump
-
Turn the pump OFF and disconnect it from the patient.
-
Remove the administration set and batteries.
-
Close the battery compartment.
-
Apply the 70% isopropyl alcohol to a cloth, then wring the cloth out to remove excess liquid.
-
Wipe all exterior areas in back-and-forth motions, vertically and horizontally. Perform 3 cycles of the exterior wipe-down, verifying complete coverage of the areas to be cleaned.
Note
Verify that the cloth does not dry out during the cleaning process. If required, wet the wipe again in the same manner. -
Wipe the pump’s cassette slot in vertical or horizontal movements, where possible. Wipe less-accessible areas in bi-directional rotations. Perform 6 cycles of the cassette slot wipe-down, verifying complete coverage of the areas to be cleaned.
-
Let the pump dry for 5 minutes.
-
Wipe the pump with a clean dry cloth. Inspect the cloth for any residue.
Caution
Do not use any cleaning agents when cleaning the battery contacts.
Disinfecting the Pump
- After cleaning thoroughly, inspect the pump carefully for any residue. If there is any visible soil, repeat the cleaning steps above.
- Repeat steps 4–8, above.
Cleaning the Accessories
-
Remove accessories from any connections (for example, remove the cradle from the IV stand and remove the pump from the cradle).
-
Apply 70% isopropyl alcohol to a cloth. Wring the cloth out to remove excess liquid.
-
Wipe all exterior areas in back-and-forth motions, vertically and horizontally. Perform 3 cycles of the exterior wipe-down, verifying complete coverage of the areas to be cleaned.
Note
Verify that the cloth does not dry out during the cleaning process. If required, wet the wipe again in the same manner. -
Let the accessory dry for 5 minutes.
-
Wipe it with a clean dry cloth and inspect the cloth for any residue. (If necessary, repeat cleaning until there is no visible residue on the cloth.)
Disinfecting the Accessories
- After cleaning thoroughly, inspect the accessories carefully for any residue. If there is any visible soil, repeat the cleaning steps above.
- Repeat steps 2–5, above.
Symbols and Labelling
The following table describes the labels and symbols that appear on the pump,
accessories, and packaging.
15132-048-1014 | Rev2.0Ver02 / 02.2023
Eitan Medical LTD
29 Yad Haruzim St.
P.O. Box 8639
Netanya 4250529
ISRAEL
+972-73-238-8888
support@eitanmedical.com
MedNet EC-REP IIb GmbH
Borkstrasse 10
48163 Münster GERMANY
Copyright and Trademarks
Copyright © 2023 Eitan Medical LTD. All rights reserved. The design, pumping
mechanism, and other features of the Avoset Infusion Pump are protected under
one or more US and Foreign Patents.
15132-048-1014 | Rev2.0Ver02 / 02.2023
Eitan Medical LTD
29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529 ISRAEL
+972-73-238-8888
Toll-free number +1.877.541.9944
support@eitanmedical.com
Technical Assistance
For technical questions and troubleshooting assistance please contact your
local agent/distributor, or contact us via email:
support@eitanmedical.com.
Serious Incident Reporting
Any serious incident that has occurred in relation to the device should be
reported to complaints@eitanmedical.com
and to the local competent authority.
Bluetooth License
Avoset is qualified under Bluetooth SIG and has licensee right to use the
Bluetooth trademarks.