Sorrel Medical SORRELWIP Wearable Infusion Pump User Manual

Sorrel Medical Ltd. Wearable Infusion Pump Users Manual

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Page 1 of 38 USER MANUAL WEARABLE INFUSION PUMP For use with Wearable Infusion Pump Software Rev1.2.0 15126-048-0001 Rev.00|Rev.1.2.0/01.2019

Page 2 of 38 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 ........................................................................................................ 6 1.4. Safety and Compliance Information ..................................................................................... 6 1.4.1 Symbols and Labeling .............................................................................................................................6 1.4.2 Compliance and Classification ................................................................................................................9 1.4.3 FCC and IC Information for EMC and Radio Frequency ....................................................................... 10 1.4.4 Biocompatibility ................................................................................................................................... 12 1.4.5 Degree of Protection against Ingress of Water and Dust .................................................................... 12 1.5. Warnings and Safety Precautions ......................................................................................12 1.5.1 General Warnings Precautions ............................................................................................................ 12 1.5.1.1 Waste Disposal ................................................................................................................................ 13 1.5.1.2 Explosion Hazard ............................................................................................................................. 14 1.5.1.3 Electromagnetic Compatibility ........................................................................................................ 14 2. WEARABLE INFUSION PUMP OVERVIEW ...............................................................................16 2.1. Top View .............................................................................................................................16 2.2. Side View ............................................................................................................................16 2.3. Pre-filled Medication Cartridge ..........................................................................................17 2.4. Single Unit Pack ..................................................................................................................17 3. INSTRUCTIONS FOR USE .........................................................................................................18 The patient is an intended operator of the Wearable Infusion Pump. ..........................................18 3.1. Step 1 - Prepare ..................................................................................................................18 3.2. Step 2 - Inject ......................................................................................................................21 3.3. Step 3 - Finish .....................................................................................................................24 4 ALARMS ..................................................................................................................................28 4.1 Alarm Information ..............................................................................................................28

Page 3 of 38 5 MAINTENANCE AND STORAGE ...............................................................................................29 5.1 Battery Classification ..........................................................................................................29 5.2 Transport and Storage ........................................................................................................29 6 TECHNICAL SPECIFICATIONS ...................................................................................................30 6.1 Pump Accuracy ...................................................................................................................30 6.1.1 Start-up and Trumpet Graphs ........................................................................................30 6.2 Pump Specifications ...........................................................................................................32 6.3 Pump Ranges ......................................................................................................................34 6.4 Electromagnetic Compatibility Statement .........................................................................34 6.4.1 Electromagnetic Emission ..............................................................................................34 6.4.2 Electromagnetic Immunity .............................................................................................34 7 COMPLIANCE INFORMATION STATEMENTS ..........................................................................36 7.1 FCC Declaration of Conformity ...........................................................................................36 7.2 EU Declaration of Conformity ............................................................................................37

Page 4 of 38 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)}. The Wearable Infusion Pump is for use at the direction of, or under the supervision of, licensed physicians and/or licensed healthcare professionals who are trained in the use of the pump and in the administration of subcutaneous infusions. The instructions for use presented in this manual should in no way supersede established medical protocol concerning patient care. Copyright, Trademark and Patent Information © 2018, Sorrel Medical Ltd. All rights reserved. Sorrel (with or without logos) is a trademark of Sorrel Medical Ltd. The design, pumping mechanism and other features of the Sorrel Wearable Infusion Pump are protected under one or more US and Foreign Patents. Disclaimer The information in this manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inadvertent inaccuracies. Sorrel Medical Ltd. reserves the right to make changes to any of its products in order to improve reliability, design and performance. The instructions presented in this manual should in no way supersede established medical protocol concerning patient care. The text and drawings herein are for the purposes of illustration and reference only; the specifications on which they are based are subject to change without notice. Warning Sorrel Medical Ltd. will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling. Refer to Warnings and Safety Precautions on page 12 for a complete list of warnings and cautions. Technical Assistance For technical questions, troubleshooting assistance and reporting of unexpected events, please contact your healthcare provider. You may also contact Sorrel Medical Ltd. support via email to the following address: support@sorrelmedical.com

Page 5 of 38 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. Terms and Abbreviations Term/Abbreviation Meaning Continuous Infusion Infusion is continuously administered in one programmable rate EMC Electromagnetic Compatibility EMI Electromagnetic Interference FCC Federal Communications Commission mL Milliliters MRI Magnetic Resonance Imaging RH Relative Humidity RF Radio Frequency ROW Rest of World (i.e. non-US) Volume To Be Infused The amount of fluid programmed or remaining to be infused. The value range is 0.1 to 3 mL

Page 7 of 38 Waste Electrical and 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. Single unit pack label Non-DEHP tubing Single unit pack label & shipping package Latex free Single unit pack label & shipping package Do not re-use Single unit pack label Non-pyrogenic Single unit pack label

Page 8 of 38 Refer to instruction manual/ booklet Single unit pack label 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 pressure range Single unit pack label & shipping package Degree of Protection against Ingress of Water and Dust Single unit pack label Defibrillation proof type CF applied part Single unit pack label Rx Only US federal law restricts this device to prescription only Single unit pack label (US/Canada) Name and address of manufacturer Single unit pack label & shipping package

Page 10 of 38 conditions defined in this standard. Other external factors, such as varying back pressure, temperature, head height, set usage, fluid restrictions, solution viscosity, or combinations of these factors may result in deviations from the performance data presented IEC 60601-1-8 - Medical electrical equipment -- Part 1-8: General requirements for basic safety andessential performance - Collateral standard: General requirements, tests and guidance for alarm systemsin medical electrical equipment and medical electrical systemsIEC 60601-1-11 - Medical electrical equipment -- Part 1-11: General requirements for basic safety andessential performance – Collateral Standard: Requirements for medical electrical equipment andmedical electrical systems used in the home healthcare environmentISO 11608-1 - Needle-based injection systems for medical use — Requirements and test methods — Part1: Needle-based injection systemsFCC: The Federal Communications Commission (FCC) regulates interstate and internationalcommunications by radio, television, wire, satellite and cable. The Wearable Infusion Pump complieswith Part 15 of the FCC Rules.Classification according to IEC 60601-1:oInternally poweredoType CFoContinuous operationoNot suitable for use in the presence of flammable aesthetic mixture with air or with oxygen ornitrous oxideClassification according to IEC 60601-2-24:oType 1 Ambulatory pump1.4.3 FCC and IC Information for EMC and Radio Frequency FCC ID: 2AR6L-SORRELWIP IC: 24632-SORRELWIP CAN ICES-3 (B) /NMB-3 (B) HVIN 04 FVIN 1.2.0 Sorrel Medical Ltd. has not approved any changes or modifications to this device by the user. Any changes or modifications not expressly approved by Sorrel Medical Ltd. could void the user’s authority to operate the equipment.

Page 11 of 38 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: a) Reorient or relocate the receiving antenna.b) Increase the separation between the equipment and receiver.c) Connect the equipment to an outlet on a circuit different from that to which the receiveris connected. d) Consult the dealer or an experienced radio/TV technician.CAN ICES-3 (B) / NMB-3 (B) This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de classe B est conforme à la norme canadienne ICES-003. Interference statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation,Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:(1) This device may not cause interference.(2) This device must accept any interference, including interference that may cause undesired operation of the device.

Page 12 of 38 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. Le fonctionnement est soumis auxdeux conditions suivantes :(1) Cet appareil ne doit pas causer d'interférences.(2) Cet appareil doit accepter toutes les interférences, y compris celles susceptibles deprovoquer un fonctionnement indésirable de l'appareil.1.4.4 Biocompatibility All materials in the pump casing and in the fluid path have been tested for biocompatibility, and are in compliance with applicable international standard ISO 10993-1 for biocompatibility. 1.4.5 Degree of Protection against Ingress of Water and Dust The Sorrel Wearable Infusion Pump meets the IP65 splash/dust requirements according to IEC 60529. 1.5. Warnings and Safety Precautions All warnings and safety precautions should be read carefully before operating the Wearable Infusion Pump. WARNING: No modification of this equipment is allowed. Safety information specific to particular pump functions appear in the relevant sections of this manual. 1.5.1 General Warnings Precautions To ensure safety and proper operation, read the User Manual before operating this device. In addition, adhere to the following safety guidelines:

Page 13 of 38 It is important that you do not try to give yourself the injection unless you have received training fromyour 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 hardsurface. Part of the Wearable Infusion Pump and pre-filled cartridge may be broken even if you cannotsee the break. Use a new Wearable Infusion Pump and pre-filled cartridge.Do not reuse the Wearable Infusion Pump and pre-filled cartridge. The Wearable Infusion Pump andpre-filled cartridge are for single use only.The Wearable Infusion Pump is only to be used with a 3 mL pre-filled cartridge.Do not use the Wearable Infusion Pump if its single pack unit is damaged.Do not use the Wearable Infusion Pump after the expiration date that appears on the single pack.To avoid damage to the pump, keep the Wearable Infusion Pump away from unattended children andpets.1.5.1.1 Waste Disposal Waste Disposal Safety Precautions Keep used pumps and packaging and tubing out of the reach of children.Pumps should be disposed of in a proper manner, considering the nature of residual fluid that maybe contained within, in accordance with disposal practices.Do not dispose of the pump in or near fire.The Wearable Infusion Pump contains a needle.When disposing of the device, use a FDA-cleared sharps disposal container.If you do not have a FDA-cleared sharps disposal container, you may use a household container thatis:omade of a heavy-duty plastic,ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to comeout,oupright and stable during use,oleak-resistant, andoproperly labeled to warn of hazardous waste inside the container.When your sharps disposal container is almost full, you will need to follow your communityguidelines for the right way to dispose of your sharps disposal container. There may be state or locallaws about how you should throw away used needles and syringes. For more information about safe

Page 14 of 38 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 yourcommunity guidelines permit this. Do not recycle your used sharps disposal container.Do not recycle the Wearable Infusion Pump without specific guidance from the device manufacturerImportant: Always keep the sharps disposal container out of the reach of children.1.5.1.2 Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. 1.5.1.3 Electromagnetic Compatibility The Wearable Infusion Pump is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard. To avoid electromagnetic interference that may affect the operation of the pump, do not use the pump near sources of strong electric and magnetic interference (EMI), such as MRI, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. Portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2-way radios, BluetoothTM devices, and microwave ovens in close proximity to this device may affect wireless communications with the Infusion pump and/or the operation of the Infusion pump. This device has been tested for compliance with FCC RF exposure limits in a portable configuration. This device must not be used with any other antenna or transmitter that has not been approved to operate in conjunction with this device. Special precautions need to be exercised regarding EMC. These include: Maintaining a minimum separation distance of 2 1⁄2 ft. (3⁄4 m) between the Infusion pump system andportable/mobile RF communications equipment.Managing the electromagnetic environment to permit the device to perform as intended withoutdisturbing other equipment.Separating the device from all other electronic equipment. If the device must be used near otherelectrical equipment, monitor the equipment to ensure there is no electromagnetic interference.Devices should not be used adjacent to or stacked with other equipment. If the device must be usedadjacent to or stacked with other equipment, monitor the device to verify normal operation.

Page 15 of 38  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.  If you identify or suspect that external RF sources or other equipment are influencing device operation (from known or unknown sources), try to (as applicable) increase the pump’s distance from the EMI source, re-orient the device, or relocate the device, The EMC limits for the Medical Device Directive 93/42/EEC (EN301489-1/-17 IEC/EN 60601-1-2:2014) are designed to provide reasonable protection against harmful interference in a typical home use installation. The equipment generates, and can radiate, radio frequency energy, and if not used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, the user is encouraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving device  Increase the distance separating between the equipment parts  Consult the manufacturer or field service technician for help Electromagnetic Safety Precautions  Do not expose the pump to therapeutic levels of ionizing radiation, as permanent damage to the pump electronic circuitry may occur. Remove the pump from the patient during therapeutic radiation sessions.  Do not expose the pump to magnetic resonance imaging (MRI) equipment and do not use the pump in the vicinity of it, as magnetic fields may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures, and keep it at a safe distance from magnetic energy.

Page 16 of 38 2. WEARABLE INFUSION PUMP OVERVIEW 2.1. Top View 2.2. Side View Pump Side Label Door Cartridge Adhesive Window Adhesive Liner Initiation Button Plastic Shell Pump Top Label

Page 17 of 38 2.3. Pre-filled Medication Cartridge 2.4. Single Unit Pack Cartridge Plunger Cartridge Cap Medication

Page 18 of 38 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 1.5.1.1 Handle the medication according to your healthcare provider's instructions, including but not limited to: refrigeration of the pre-filled cartridge. Review the information written on the paper cover of the single unit pack including the expiration date and the medication information.

Page 19 of 38 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. 3.1.5 Visually inspect the pump to verify integrity prior to use. If there are any cracks in the plastic shell of the pump, indication that the pump is damaged or impaired, or if the needle is visible - do not use the pump, and proceed to consult with your healthcare provider.

Page 20 of 38 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. Correct insertion: Incorrect insertion:

Page 21 of 38 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  Arm: back or side of the upper arm  Thigh: front of the thigh  Lower back  Buttocks 3.1.9.1 Prepare the injection site by swabbing it with an alcohol wipe. Swabbing of the skin and application of the pump to the skin should be done consecutively, within a reasonable timeframe. 3.2. Step 2 - Inject 3.2.1 Remove the adhesive liner from the Wearable Infusion Pump by pulling at the adhesive liner tab. Peel one side of the adhesive liner, and then the other. The adhesive liner, once separated from the Wearable Infusion Pump, can be discarded.  Once the adhesive liner has been removed, a beep will sound and the initiation button will light up momentarily

Page 22 of 38 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. Abdomen placement: Thigh placement: Beep

Page 23 of 38 Arm placement: 3.2.3 Press the initiation button to begin delivery of the medication  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. If still there is no green light, an error has occurred. Do not continue using the pump. Remove the pump from your skin and contact your healthcare provider for further assistance. Beep

Page 24 of 38 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 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. Step 3 - Finish When the injection is finished you should hear a beeping sequence and the green light will stop blinking. At this point no light illuminating the initiation button should be seen. A slight stinging sensation in the injection site is expected.

Page 25 of 38 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.

Page 26 of 38 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. The Sorrel Wearable Infusion Pump smartphone application allows you to download the treatment summary from our Wearable Infusion Pump and provides a summary of your treatment; date, time, flow rate, volume infused, pump serial number, and alarm information if relevant. This information can then be shared from your smartphone.

Page 27 of 38 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. If it continues, contact your healthcare provider for further assistance.

Page 28 of 38 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. 4.1.1 If an alarm occurs, the use of the Wearable Infusion Pump has ended, and the device must be removed from the body. Once removed, consult with your healthcare provider. 4.1.2 Alarm volume is always Max. Maximum alarm volume is 55 dBA Beep

Page 29 of 38 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. To safeguard the pump against prolonged exposure to dust and moisture, the pump must be stored in a clean and dry environment. Specific recommendations for transport and long term storage conditions are listed in the following table. Condition Parameters Transport (transient – up to 24 hours) Long term storage Temperature -40ºC (-40ºF) to +70ºC (+158ºF) 2ºC (36ºF) to 27ºC (81ºF) Relative humidity 20% RH to 85% RH 20% RH to 85% RH Atmospheric pressure 69.6 kPa to 106 kPa (696 hPa to 1060 hPa) 69.6 kPa to 106 kPa (696 hPa to 1060 hPa)

Page 30 of 38 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). Normal conditions to ensure optimal accuracy  Barometric pressure of sea level altitude (101kPa)  Subcutaneous medication with water like fluid characteristics In the Wearable Infusion Pump, as in all infusion systems, external factors may cause fluctuations in rate accuracy. Conditions that can cause flow fluctuations include:  Fluid characteristics that deviate from water-like characteristics, such as density, viscosity and homogeneity  Barometric pressure below 101kPa 6.1.1 Start-up and Trumpet Graphs The following graphs and curves were derived from the pump accuracy testing procedures described in the IEC60601-2-24 standard. The start-up graphs represent startup flow versus operating time for the first half of the 3 mL cartridge (filled with 3 mL water) from the start of the infusion ("Stabilization period"), while the trumpet curve represents the percent flow rate deviation from the programmed rate over time of the second half of the cartridge ("Analysis period"). The horizontal axis represents the observation time intervals, which were adapted to represent the time of the delivery. Over long observation windows, short-term fluctuation has little effect on accuracy, as represented by the flat part of the curve. As the observation window is reduced, short-term fluctuations have a greater effect, as represented by the "mouth" of the trumpet.

Page 31 of 38 Figure 6.1. Delivery Startup Graph ("Stabilization period"), first 1.5 hours of Test Period, 1 mL/h Figure 6.2. Trumpet Graph ("Analysis period"), second (and last) 1.5 hours of Test Period, 1 mL/h 00.20.40.60.811.2010 20 30 40 50 60 70 80 90Flow rate [mL/h] Time [min] -6.000%-5.000%-4.000%-3.000%-2.000%-1.000%0.000%1.000%2.000%0 5 10 15 20 25 30Error [%] Observation Window [min] maxminaverage

Page 32 of 38 Figure 6.3. Delivery Startup Graph ("Stabilization period"), first hour of Test Period, 1.5 mL/h Figure 6.4. Trumpet Graph ("Analysis period"), second (and last) hour of Test Period, 1.5 mL/h 6.2 Pump Specifications The following table lists and describes pump specifications. Parameter Description GENERAL Type of Pump Container, type 1 ambulatory Operating Principle Piston 00.20.40.60.811.21.41.61.8010 20 30 40 50 60Flow rate [mL/h] Time [min] -5.000%-4.000%-3.000%-2.000%-1.000%0.000%1.000%2.000%3.000%0 5 10 15 20 25 30Error [%] Observation Window [min] maxminaverage

Page 33 of 38 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 activation of the occlusion alarm 1 mL/h: 02:27 [min:sec], 1.5 mL/h: 02:05 [min:sec] History log Yes ELECTRICAL SAFETY Electrical Safety Compliant with IEC 60601-1 - Edition 3.1 Electromagnetic compatibility Compliant with IEC 60601-1-2 – Edition 4.0 Recovery time for defibrillation-proof applied parts < 1 sec MECHANICAL AND POWER SPECIFICATIONS Pump Size 23 x 95 x 46 mm HxWxD (0.91 x 3.74 x 1.81 inches) Pump Weight 70 grams Ingress Protection IP65 Power Source Non-rechargeable Li- Manganese battery 3.0 V/1000 mA Battery consumption 6 hours of work at 0.5 mL/h OPERATING ENVIRONMENT Temperature +5°C to 40°C (41°F to 104°F) Relative Humidity 15% to 95% Atmospheric pressure 50 kPa to 106 kPa (500 hPa to 1060 hPa) TRANSPORT ENVIRONMENT Temperature -40°C to + 70°C (-40°F to 158°F) Relative Humidity 20% to 85% Atmospheric pressure 69.6 kPa to 106 kPa (696 hPa to 1060 hPa) STORAGE ENVIRONMENT Temperature 2°C to 27°C (36°F to 81°F) Relative Humidity 20% to 85% Atmospheric pressure 69.6 kPa to 106 kPa (696 hPa to 1060 hPa)

Page 34 of 38 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.  Avoid locations exposed to chemicals or explosive gases. 6.3 Pump Ranges Parameter Range Increments Volume To Be Infused (mL) 0.1-3 0.1 Rate (mL/h) 0.01-60 0.01 Time 00:01-05:59 1 min / 1 hour 6.4 Electromagnetic Compatibility Statement The following sections provide information about testing of and recommendations for electromagnetic compatibility statement. 6.4.1 Electromagnetic Emission The Wearable Infusion Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should ensure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 class B The pump is suitable for use in home healthcare environment. 6.4.2 Electromagnetic Immunity The Wearable Infusion Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should ensure that it is used in the following environment.

Page 35 of 38 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. Test Method Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) per IEC 61000-4-2 ± 8 kV contact; ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air*,** ±8 kV contact; ±15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Radiated RF EM field immunity per IEC 61000-4-3 10 V/m, 80 MHz – 2.7 GHz, 80 % AM at 1 kHz* 10 V/m, 80 MHz – 2.7 GHz, 80 % AM at 1 kHz NA 10 V/m, 26 MHz – 2.5 GHz** 10 V/m, 26 MHz – 2.5 GHz NA Power frequency (50/60 Hz) magnetic field immunity per IEC 61000-4-8 30 A/m* 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. RF wireless communications equipment fields Immunity per IEC 61000-4-3 Frequencies and levels as specified at IEC 60601-1-2, Table 9* Max. 28 V/m NA * The pump was tested according to the EMC requirements of IEC 60601-1-2 (fourth edition) ** The pump was tested according to the EMC requirements of ISO 11608-1 (third edition)

Page 38 of 38 MEDNET GmbH Borkstrasse 10 48163 Munster, Germany Sorrel Medical Ltd. 29 Yad Haruzim St. P.O.Box 8639 Netanya 4250529, Israel 0123 eng Manufactured for: 15126-048-0001 Rev.00|Rev1.2.0/01.2019

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