5126-048-0001 Rev.00|Rev.1.2.0/01.2019 USER MANUAL WEARABLE INFUSION PUMP For use with Wearable Infusion Pump Software Rev1.2.
Table of Contents 1. INTRODUCTION ........................................................................................................................5 1.1. Product Intended Use and Indications for Use ....................................................................5 1.2. Terms and Abbreviations .....................................................................................................5 1.3. Document Conventions ......................................................................
5 MAINTENANCE AND STORAGE ...............................................................................................29 5.1 Battery Classification ..........................................................................................................29 5.2 Transport and Storage ........................................................................................................29 6 TECHNICAL SPECIFICATIONS......................................................................................
Important Notice The Wearable Infusion Pump User Manual is delivered subject to the conditions and restrictions listed in this section. Clinicians and users should read the entire User Manual prior to operating the Wearable Infusion Pump in order to fully understand the functionality and operating procedures of the pump. Prescription Notice Federal United States law restricts this device for sale by or on the order of a physician only {21 CFR 801.109(b) (1)}.
1. INTRODUCTION 1.1. Product Intended Use and Indications for Use The Wearable Infusion Pump is intended for use in subcutaneous infusion of prescribed liquid medication of up to 6 hours. The pump is medication agnostic (no specific medication) and designed for pediatric and adults subcutaneous treatment. 1.2.
1.3. Document Conventions The following messages in this manual prompt reader to pay special attention to specific points: Warnings alert the user about situations to be avoided, the result of which could lead to death or serious injury. They may also describe potential serious adverse reactions and safety hazards. Cautions caution the user of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or damage to the equipment or other property.
Waste Electrical and Single unit pack label Electronic Equipment (WEEE) Disposal This symbol indicates that used batteries and electronic equipment must not be disposed of as unsorted municipal waste, and must be collected separately. Contact an authorized representative for information concerning the decommissioning of your equipment.
Refer to instruction Single unit pack label manual/ booklet Keep away from sunlight Single unit pack label & shipping package Keep dry Shipping package Storage temperature range Single unit pack label & shipping package Storage humidity range Single unit pack label & shipping package Storage atmospheric Single unit pack label & shipping pressure range package Degree of Protection Single unit pack label against Ingress of Water and Dust Defibrillation proof type CF Single unit pack label a
Sterilized using ethylene Single unit pack label & shipping oxide package Serial number Single unit pack label & pump side label & shipping package Catalogue Number Single unit pack label & shipping package Authorized representative Single unit pack label (ROW) in the European Community Sorrel Medical company Single unit pack label & pump top logo label & shipping package Use by date: YYYY-MM-DD Single unit pack label & pump side label Instructions for use Single unit pack label (ROW) rega
conditions defined in this standard.
Sorrel Medical Ltd. n’approuve aucune modification apportée à l’appareil par l’utilisateur, quelle qu’en soit la nature. Tout changement ou modification peuvent annuler le droit d’utilisation de l’appareil par l’utilisateur. Class B digital device warnings The FCC Wants You to Know This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules.
Wireless notice This device complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS‐102 of the ISED radio frequency (RF) Exposure rules. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Cet appareil contient des émetteurs / récepteurs exemptés de licence conformes aux RSS (RSS) d'Innovation, Sciences et Développement économique Canada.
It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider. Do not shake the Wearable Infusion Pump. Do not use the Wearable Infusion Pump and pre-filled cartridge if either has been dropped onto a hard surface. Part of the Wearable Infusion Pump and pre-filled cartridge may be broken even if you cannot see the break. Use a new Wearable Infusion Pump and pre-filled cartridge.
sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal . Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness.
2. WEARABLE INFUSION PUMP OVERVIEW 2.1. Top View Initiation Button Pump Top Label Window Plastic Shell Adhesive Adhesive Liner Cartridge Door 2.2.
2.3. Pre-filled Medication Cartridge Cartridge Cap Medication Cartridge Plunger 2.4.
3. INSTRUCTIONS FOR USE The patient is an intended operator of the Wearable Infusion Pump. 3.1. Step 1 - Prepare 3.1.1 Gather all materials in a clean, well-lit area: Wearable Infusion Pump single unit kit Pre-filled medication cartridge Adhesive bandage Alcohol wipe Cotton ball or gauze pad Sharps disposal container* *In case you do not have a sharps disposal container – please refer to section 1.5.1.
3.1.2 Visually inspect the cartridge to verify cartridge integrity. If there are any cracks or leaks coming from the cartridge- do not use the cartridge, and proceed to consult with your healthcare provider. 3.1.3 Peel the paper cover from the single unit pack and proceed to remove the plastic cover. 3.1.4 Now that the Wearable Infusion Pump is visible, remove the pump from the single unit pack. It is recommended to keep the single unit pack for later; it can be used for easy disposal of the pump. 3.1.
3.1.6 Open the pump door. 3.1.7 Load the cartridge into the pump, with the cartridge cap head first, and push inside until secure in place.
3.1.8 Close the pump door; you should hear a click when the door closes successfully. 3.1.9 Choose an injection site that is appropriate for subcutaneous injections; a relatively smooth skin surface, without hair, open wounds or scars: Abdomen: at or under the level of the belly button, about two inches away from the navel 3.1.9.1 Arm: back or side of the upper arm Thigh: front of the thigh Lower back Buttocks Prepare the injection site by swabbing it with an alcohol wipe.
Beep 3.2.2 Prepare your injection area for application of the pump; ensure there are no folds of the skin, and place the pump on your skin firmly.
Arm placement: 3.2.3 Press the initiation button to begin delivery of the medication Beep The pump shall beep with initiation of delivery and the green light shall begin blinking, and will continue blinking throughout the delivery. If at this point you do not see a green blinking light illuminating the initiation button, try pressing the initiation button once more. Make sure the cartridge has been inserted into the pump, and that the pump is adhered to the skin.
3.2.4 During delivery: Do not open the pump door during delivery Take notice if alarms sound during delivery (refer to section 4) Take notice if there is leakage from the pump during delivery A slight stinging sensation in the injection site is expected. If there is leakage from the pump during delivery, an error has occurred. Do not continue using the pump. Remove the pump from your skin and contact your healthcare provider for further assistance. 3.3.
3.3.1 Remove the pump from the skin by pulling at the adhesive. There should not be a needle visible when the pump is removed from the body. If this is not the case - take extra care when handling and disposing of the pump. 3.3.2 Look through the pump window to verify that the medication was delivered, by viewing that the cartridge is empty.
3.3.3 Optional: Return the used pump into its original single unit pack for easy handling and disposal of the used pump. 3.3.4 Optional: For downloading the treatment summary from your Wearable Infusion Pump prior to disposal, open the Sorrel Wearable Infusion Pump smartphone application and follow the instructions.
3.3.5 Dispose of the pump into a designated sharps disposal container. This device is for single use only. Do not try to reuse it. 3.3.6 Check your injection site. If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed. Some irritation or redness of the skin may be present briefly after the injection has ended. This should disappear shortly.
4 ALARMS 4.1 Alarm Information The Wearable Infusion Pump has only one type of alarm (high-priority), which may occur due to several reasons. In case of alarm, there will be consecutive beeping in two cycles, and then a 5 minute break before the next cycle. In addition, the initiation button will turn from green to red. Removing the device from the body will stop the alarm beeping sounds. Alarm information can be seen in the treatment summary, via the smartphone application. Beep 4.1.
5 MAINTENANCE AND STORAGE This device is for single use only! Do not try to reuse, clean or disinfect it. 5.1 Battery Classification The UL 1642 Standard for Lithium batteries classifies the Lithium-Manganese battery used in the Wearable Infusion Pump as primary battery (non-rechargeable). 5.2 Transport and Storage The pump should always be transported in its single pack. During handling and transport, protect the pump and the single pack from water, excessive humidity, and heat sources.
6 TECHNICAL SPECIFICATIONS 6.1 Pump Accuracy The dose accuracy of the Wearable Infusion per ISO 11608-1 under normal conditions is ±10% for dose of 0.1mL and ±5% for doses of up to 3mL. The rated accuracy of the Wearable Infusion per IEC 60601-2-24 under normal conditions is ±5%. Testing was performed under normal conditions at room temperature (25oC, 72 oF).
1.2 Flow rate [mL/h] 1 0.8 0.6 0.4 0.2 0 0 10 20 30 40 50 Time [min] 60 70 80 90 Figure 6.1. Delivery Startup Graph ("Stabilization period"), first 1.5 hours of Test Period, 1 mL/h 2.000% 1.000% Error [%] 0.000% -1.000% 0 5 10 15 20 25 30 max -2.000% min -3.000% average -4.000% -5.000% -6.000% Observation Window [min] Figure 6.2. Trumpet Graph ("Analysis period"), second (and last) 1.
1.8 Flow rate [mL/h] 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 0 10 20 30 Time [min] 40 50 60 Figure 6.3. Delivery Startup Graph ("Stabilization period"), first hour of Test Period, 1.5 mL/h 3.000% 2.000% Error [%] 1.000% 0.000% -1.000% 0 5 10 15 20 25 30 max min -2.000% average -3.000% -4.000% -5.000% Observation Window [min] Figure 6.4. Trumpet Graph ("Analysis period"), second (and last) hour of Test Period, 1.5 mL/h 6.
Patient population Adult and pediatric Delivery Mode Continuous Delivery route Subcutaneous System delivery accuracy (Nominal) ±5% Sensors Air sensor, cartridge sensor, temperature sensor Occlusion alarm threshold 4 bar Maximum time for 1 mL/h: 02:27 [min:sec], 1.5 mL/h: 02:05 [min:sec] activation of the occlusion alarm History log Yes ELECTRICAL SAFETY Electrical Safety Compliant with IEC 60601-1 - Edition 3.1 Electromagnetic compatibility Compliant with IEC 60601-1-2 – Edition 4.
The following list provides guidelines about environmental conditions and situations to be avoided when working with or storing the Wearable Infusion Pump: Avoid locations where there is inadequate ventilation. Avoid locations where sudden impact or vibration may occur. Avoid damp locations or locations where moisture level may increase considerably. Avoid locations with large temperature fluctuations. Avoid locations near an electrical heating apparatus.
Use of this equipment adjacent to or stacked with other equipment (see below table) should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
7 COMPLIANCE INFORMATION STATEMENTS 7.1 FCC Declaration of Conformity We Sorrel Medical Ltd. declare: Type of equipment: Infusion Pump Brand name or trademark: Wearable Infusion Pump Product Identification number: SORREL V04 | FCC ID: 2AR6L-SORRELWIP Applicable Compliance Statements: (e.g. for part 15 devices see §15.19(a)(3)) Country of origin: Israel Manufacturer: Sorrel Medical Ltd. Responsible Party name (IN USA): Z & B Enterprises, Inc.
7.2 EU Declaration of Conformity We Sorrel Medical Ltd. declare under our sole responsibility: Type of equipment: Infusion Pump Brand name or trademark: Wearable Infusion Pump Product Identification number: V04 Traceability Identification: 15126-000-0001 Country of origin: Israel Manufacturer: Sorrel Medical Ltd. The authorized representative located within the Community is: Mrs. Dr.
15126-048-0001 Rev.00|Rev1.2.0/01.2019 Manufactured for: MEDNET GmbH Borkstrasse 10 48163 Munster, Germany Sorrel Medical Ltd. 29 Yad Haruzim St. P.O.
