Sorrel Medical SORRELWIP Wearable Infusion Pump User Manual

Sorrel Medical Ltd. Wearable Infusion Pump Users Manual

Users Manual

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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
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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
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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
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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
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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
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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. It may also be used to alert against unsafe practices.
Notes provide additional information to help obtain optimal equipment performance.
1.4. Safety and Compliance Information
The following section presents important labeling, safety and compliance information:
1.4.1 Symbols and Labeling
The following table describes the symbols that appear on the Wearable Infusion Pump's labels, and identifies
their locations on the labels:
Symbol
Location
Single unit pack label (ROW)
& shipping package (ROW)
Single unit pack label & shipping
package
Single unit pack label
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Single unit pack label
Single unit pack label & shipping
package
Single unit pack label & shipping
package
Single unit pack label
Single unit pack label
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Single unit pack label
Single unit pack label & shipping
package
Shipping package
Single unit pack label & shipping
package
Single unit pack label & shipping
package
Single unit pack label & shipping
package
Single unit pack label
Single unit pack label
Rx Only
Single unit pack label (US/Canada)
Single unit pack label & shipping
package
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Single unit pack label & shipping
package
Single unit pack label & pump side
label & shipping package
Single unit pack label & shipping
package
Single unit pack label (ROW)
Single unit pack label & pump top
label & shipping package
Single unit pack label & pump side
label
Single unit pack label (ROW)
1.4.2 Compliance and Classification
This manual has been written in conjunction with the requirements of the following International Standards:
IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-24 - Medical Electrical Equipment - Part 2-24: Particular Requirements for Safety of Infusion
Pumps and Controllers. Data presented in the Technical Specification section reflect specific test
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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 and
essential performance - Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 60601-1-11 - Medical electrical equipment -- Part 1-11: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
ISO 11608-1 - Needle-based injection systems for medical use — Requirements and test methods — Part
1: Needle-based injection systems
FCC: The Federal Communications Commission (FCC) regulates interstate and international
communications by radio, television, wire, satellite and cable. The Wearable Infusion Pump complies
with Part 15 of the FCC Rules.
Classification according to IEC 60601-1:
oInternally powered
oType CF
oContinuous operation
oNot suitable for use in the presence of flammable aesthetic mixture with air or with oxygen or
nitrous oxide
Classification according to IEC 60601-2-24:
oType 1 Ambulatory pump
1.4.3 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.
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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 receiver
is 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.
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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 aux
deux conditions suivantes :
(1) Cet appareil ne doit pas causer d'interférences.
(2) Cet appareil doit accepter toutes les interférences, y compris celles susceptibles de
provoquer 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:
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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.
Do not reuse the Wearable Infusion Pump and pre-filled cartridge. The Wearable Infusion Pump and
pre-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 and
pets.
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 may
be 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 that
is:
omade of a heavy-duty plastic,
ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come
out,
oupright and stable during use,
oleak-resistant, and
oproperly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community
guidelines for the right way to dispose of your sharps disposal container. There may be state or local
laws about how you should throw away used needles and syringes. For more information about safe
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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.
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 and
portable/mobile RF communications equipment.
Managing the electromagnetic environment to permit the device to perform as intended without
disturbing other equipment.
Separating the device from all other electronic equipment. If the device must be used near other
electrical 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 used
adjacent to or stacked with other equipment, monitor the device to verify normal operation.
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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.
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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
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2.3. Pre-filled Medication Cartridge
2.4. Single Unit Pack
Cartridge Plunger
Cartridge Cap
Medication
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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.
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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.
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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:
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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
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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
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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
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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.
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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.
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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.
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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.
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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
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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)
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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.
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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
0
0.2
0.4
0.6
0.8
1
1.2
010 20 30 40 50 60 70 80 90
Flow 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 30
Error [%]
Observation Window [min]
max
min
average
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
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
010 20 30 40 50 60
Flow 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 30
Error [%]
Observation Window [min]
max
min
average
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 36 of 38
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.
Address: 12154 Darnestown Road, #236, Gaithersburg, MD 20878, USA
Telephone: 301-251-9570
Internet E-Mail: rhonashanker07@verizon.net
Standards applied:
● FCC Part 15B - For Unintentional radiators; ( test report number: XXX)
● FCC Part 15C - For Intentional radiators; ( test report number: XXX)
Test reports/ certificates issued by: TBD
Telecom Certification Body by: TBD
As manufacturer/ manufacturer's authorized representative within the USA, we declare under our sole of
responsibility that the equipment follows the provisions of FCC Equipment Authorization Procedures under
CERTIFICATION (47 CFR Section 2.907) and / or SUPPLIER’S DECLARATION OF CONFORMITY (47 CFR Section
2.906) as stated above.
Thus, is placed on the product
Date of issue: December 28, 2018
Place of issue: Israel
(Signature & Name of authorized person) (Company Stamp)
Page 37 of 38
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. Stephanie Vorwerk
Company: MedNet GmbH
Address: Borkstrasse 10, Munster 48163, Germany
Essential requirements according to directives:
● 2014/30/EU EMCD
● 2014/35/EU LVD
● 1999/5/EC R&TTE or 2014/53 RED
● 2011/65/EU RoHS
Standards applied:
● EN 301489-17, EN 301489-3
● EN 300 328 V2.1.1 , EN 300 330 V2.1.1
● EN 62479
Other normative references: CEPT Radio Resolution 4561
Radio Equipment Class: Class 2
Test reports/ certificates issued by: Global United Technology Services Co., Ltd. (GTS) China.
As manufacturer/ manufacturer's authorized representative within the EEA, we declare under our sole of
responsibility that the equipment follows the provisions of the Directive(s) as stated above.
Thus, is placed on the product
Date of issue: December 28, 2018
Place of issue: Israel
(Signature & Name of authorized person) (Company Stamp)
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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