Infusion Pump

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 [email protected]

Technical Assistance

For technical questions and troubleshooting assistance please
contact your local agent/distributor, or contact us via email:
[email protected].

Serious Incident Reporting

Any serious incident that has occurred in relation to the device
should be reported to [email protected] 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:

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.

Avoset Infusion Pump
Safety Quick Guide
15132-048-1014 | Rev2.0Ver02 / 02.2023

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 [email protected]

Technical Assistance
Serious Incident Reporting
Bluetooth License

For technical questions and troubleshooting assistance please contact your local agent/distributor, or contact us via email: [email protected].
Any serious incident that has occurred in relation to the device should be reported to [email protected] and to the local competent authority.
Avoset is qualified under Bluetooth SIG and has licensee right to use the Bluetooth trademarks.

Table of Contents
Purpose ……………………………………………………………………………………………..1
Safety Guidelines ………………………………………………………………………………………….2 Getting Help ……………………………………………………………………………………….2 Child Safety…………………………………………………………………………………………2 Avoid Deviation from Accuracy……………………………………………………………..3 Avoid Exposure to Harmful Use Conditions …………………………………………….4 Storage ………………………………………………………………………………………………5 Pump Guidelines …………………………………………………………………………………5 Administration Set Guidelines……………………………………………………………….7 Battery Guidelines……………………………………………………………………………….9 Setting up a Treatment Safely ……………………………………………………………..10 Disposal Guidelines ……………………………………………………………………………11
Cleaning and Disinfecting …………………………………………………………………………….12 Cleaning the Pump …………………………………………………………………………….14 Disinfecting the Pump ………………………………………………………………………..15 Cleaning the Accessories …………………………………………………………………….15 Disinfecting the Accessories………………………………………………………………..16
Symbols and Labelling …………………………………………………………………………………17

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.

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

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)

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

Continue on next page…
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.

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Avoset Infusion Pump Safety Quick Guide

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.
Continue on next page…

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Avoset Infusion Pump Safety Quick Guide

Caution
Do not pull or stretch the administration set tubing when the pump is in use.

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Avoset Infusion Pump Safety Quick Guide

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).

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

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.

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Avoset Infusion Pump Safety Quick Guide

Caution
Do not clean or disinfect the pump unless you are trained.
Caution
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.

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Avoset Infusion Pump Safety Quick Guide

Cleaning the Pump 1. Turn the pump OFF and disconnect it from the patient. 2. Remove the administration set and batteries. 3. Close the battery compartment. 4. Apply the 70% isopropyl alcohol to a cloth, then wring the cloth out to remove excess liquid. 5. 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.
6. 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.
7. Let the pump dry for 5 minutes.
Continue on next page…

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Avoset Infusion Pump Safety Quick Guide

8. 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 1. After cleaning thoroughly, inspect the pump carefully for any residue. If there is any visible soil, repeat the
cleaning steps above.
2. Repeat steps 4­8, above.
Cleaning the Accessories 1. Remove accessories from any connections (for example, remove the cradle from the IV stand and remove the
pump from the cradle).
2. Apply 70% isopropyl alcohol to a cloth. Wring the cloth out to remove excess liquid. 3. 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. Continue on the next page…

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Avoset Infusion Pump Safety Quick Guide

Note
Verify that the cloth does not dry out during the cleaning process. If required, wet the wipe again in the same manner.
4. Let the accessory dry for 5 minutes. 5. 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 1. After cleaning thoroughly, inspect the accessories carefully for any residue. If there is any visible soil, repeat the
cleaning steps above.
2. Repeat steps 2­5, above.

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Avoset Infusion Pump Safety Quick Guide

Symbols and Labelling

The following table describes the labels and symbols that appear on the pump, accessories, and packaging.

Symbol Symbol Title

Location

Description

Storage Temperature Range packaging

Safe temperature range for storing packaged device.

Storage Humidity Range

packaging

Atmospheric Pressure Range packaging

Safe humidity range for storing packaged device. Safe atmospheric pressure range for packaged device.

Keep Dry
This Side Up Fragile
Do not use if package is damaged CE

packaging packaging packaging packaging pump back

Product is not waterproof. Keep product dry.
Do not store on side or upside down.
Fragile; handle with care.
Indicates a medical device that should not be used if the package has been damaged or opened. The product meets Medical Device Regulation concerning medical devices for European Conformity.

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Avoset Infusion Pump Safety Quick Guide

Symbol

Symbol Title
EC Rep Direct Current Serial Number
Catalog Number

Location
pump back pump back pump back
pump back

Consult Instructions for Use

Cradle label and Cassette Lock label

Safety (Read Instructions)

pump back

Description
Authorized representativeof European Conformity. The device uses electrical direct current. Serial number for the specific device (unique to each). Indicates the manufacturer’s catalog number so that the medical device can be identified. Indicates the need for the user to consult the instructions for use.
Consulting the accompanying documents is mandatory.

Date of Manufacture

pump back

Date that the device was produced.

Manufacturer

pump back

Defibrillation-proof

pump back

IP 34
GTIN

Ingress Protection

pump back

Global Trade Item Number pump back

Indicates the name and address of the device manufacturer.
Indicates the device is defibrillation-proof and the degree of protection against electric shock. Equipment type CF applied part. Indicates the device is protected from water spray from any direction. Identifying number for these devices.

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Avoset Infusion Pump Safety Quick Guide

Symbol

Symbol Title
Electrical and electronic waste

Location
pump back

Description
Dispose of according to local ordinances.

MR Unsafe FCC Logo

Medical Device Batch Code

Rx Only

Prescription Battery Orientation

Caution

pump back pump back

Keep away from magnetic resonance imaging (MRI) equipment. The device presents a projectile hazard.
FCC symbol.

pump back
pump back
pump back inside pump battery compartment documentation

The device is a medical device.
Indicates the manufacturer’s batch code so that the batch or lot can be identified.
US Federal law restricts this device to prescription only. Shows orientation to insert AA batteries.
Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

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eng

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 [email protected]
MedNet EC-REP IIb GmbH Borkstrasse 10 48163 Münster GERMANY

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Avoset Infusion Pump Safety Quick Guide

References

• Eitan Medical - Drug Delivery and Infusion Solutions
• Eitan Medical - Drug Delivery and Infusion Solutions