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1. Introduction and OverviewOverview of the SeaforiaTM Sperm Separation SystemThe System includes a variety of Kits for semen preparation for IVF, IUI & ICI, suitable for different semen volume, and a Heating Device or a Stativ in an incubator, as a heating platform.With the Seaforia™ System the sperm cells separation procedure can be easier, faster and cost effective, yielding high quality end product.

Exploring the SeaforiaTM Sperm Separation Lab KitThe kits are classified according to the semen sample volume:

Instructions for Use

TM

The key benefits of the Lab Kit:• Unique, simple and easy to operate• Minimal incubation period of 15-30 minutes.• Allows a natural procedure for sperm cells separation with minimal handling & working space for operation • Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced• Separation of the progressively motile sperm cells with high percentage of normal morphology• Eliminates round non-sperm cells and non motile sperm cells• Adapted to variable semen sample volume• Can be performed by doctors and healthcare professionals, hence improves the fertility treatments accessibility• Can be conjugated to a following IUI, ICI or IVF• Especially designed polypropylene tips for reduction of vacuum forces directed on the bio sample during deposition and drawing

Seaforia™ Lab Kit - Benefits and Risks

Introduction

The main risks in the SeaforiaTM Lab Kit:As in other sperm preparation procedures, operator’s contamination might occur.Following the instructions when performing the procedure will minimize the contamination risk.

Principle of Operation - Lab KitSeaforia™ Lab Kit enables the migration of the best spermatozoa (progressively motile and normal morphology) from the original semen sample to the sperm medium. The immotile and/or dead sperm cells, round cells and debris remain in the original semen sample. Sperm separation with Seaforia™ Lab Kit can be performed with all approved/cleared sperm preparation medium, as commonly utilized in sperm preparation procedures.Progressively motile and normal morphology sperm cells are the preferable prerequisite for fertilization and embryo development. However, the preparation procedure is not a guarantee for the occurrence of ovum fertilization and for further normal development of the embryo since additional factors contribute to the success of these stages.

Indications for Use - Lab KitSeaforia™ Sperm Separation Lab Kit is a product designed for IVF and male fertility laboratories, doctor’s clinics and fertility centers.The Lab Kit enables semen preparation and enrichment procedures by means of motile sperm cells separation, in a natural way with minimal handling. The Lab Kit provides selection of motile spermatozoa for further use in IVF, ICI* or IUI* procedures.* Sperm separation for IUI and ICI procedures is recommended utilizing semen samples with motile sperm cells concentration ≥5x106 sperm cells/ml.

The Seaforia™ Heating Device is needed for successful procedure.

Lab Kit Duo 1.0ml Lab Kit Duo 1.5mlLab Kit Duo 2.0ml

0.5+0.5ml x6

Lab Kit Duo (A) Separator: (B) Tip

(B)(A)

x6

x60.5+1.0ml 1.0+1.0ml

The SeaforiaTM Sperm Separation Heating DeviceThe Heating Device is a unique heating system designed specifically for SeaforiaTM Separators.The SeaforiaTM Heating Device enables the sperm separation procedure to be performed at the optimal temperature. The Heating Device is simple to operate. It contains:• 3 cavities for separators placement (on its top)• Power switch: Push button - toggle between on and off, marked as• LED indicators: Green LED indicating: "Ready for use"; Red LED indicating: “Warming up”• USB connector to USB port (power sources)

Principle of OperationThe SeaforiaTM Heating Device is desktop mounted, capable of maintaining the temperature required for the sperm separation procedure. It consists of thermally controlled, factory calibrated resistive load heaters. The SeaforiaTM Heating Device requires a pre-heat time of up to 45 minutes before starting the sperm separation procedure.

Lab Kit 0.5mlLab Kit 1.0ml Lab Kit 1.5ml

0.5ml x3x3

Lab Kit (A) Separator: (B) Tip

(B)(A)

x31.0ml 1.5ml

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2. Preparation

Semen Collection – Instruct Your PatientInstruct your patient to collect his ejaculated semen sample into a sterile, clean, wide-mouthed container. The sperm cells separation procedure using the SeaforiaTM Lab Kit should start within 1 hour of ejaculation.

IMPORTANT INFORMATION• Carefully follow the instructions below. Perform procedure in accordance with the correct sequence of loading semen and medium. Partial compliance might affect the procedure results.• Since semen is a body fluid sample protective measures for working with body fluids must be applied. Disposing the kit components after use should be in accordance with local regulations. The Heating Device is not autoclavable or re-sterilization safe.• Using the Heating Device: * Do not remove or tilt the Heating Device or separators while the procedure is performed. * The Heating Device is capable of either working with common host computer USB ports, or with an AC power adaptor 5 VDC, 1000mA, compliant with relevant safety standards. * When using a PC USB port, it is critical to connect the cable DIRECTLY to the computer, and NOT through a USB hub/splitter. * If an electricity problem occurs during the procedure, verify that the Heating Device is on. * Do NOT use the Heating Device, or any other component of the system, if there is any doubt regarding its physical integrity. * The Heating Device is not lightning protected. * In case of a damaged power switch, contact the distributor and replace the device. Do not use an AC power adaptor if it is broken or damaged in any way. * Do not rinse, soak, immerse, wet or wash the Heating Device.• A separator should not be used if it accidently falls while containing semen.• The SeaforiaTM Lab Kit is forbidden for re-use.

NOTE:• Start performing the following steps approximately 45 minutes prior to actually conducting the sperm separation process.

1. Allow sperm medium to reach room temperature. * In case Seaforia™ Stativ is used for procedure please skip steps 2-7, consult with Stativ IFU and continue to step 8.

2. Place the Heating Device on a working platform/desk in a clear area. Make sure that the device is leveled and stable.

3. Connect the Heating Device to one of the following power sources: • AC-USB power adaptor 5 VDC, 1000mA • Desktop PC USB port

4. Switch on the Heating Device using the rear power switch (the LED indicators should flash momentarily).

5. Verify that the Red light (LED on the right side of the Heating Device) is on, indicating that the Heating Device is warming up.

Getting Started…

NOTE:In case the Red light is not working:* Verify that the power connection is working: • USB power adaptor – well connected and working. • PC USB port – the PC is “On”. Alternatively use a different USB port. • If the Green light is on, the Heating Device is at working temperature.* Check the LEDs - if neither LEDs are on, the Heating Device is turned off or not connected to a power source; toggle the power button of the Heating Device. If none of the LEDs turns on, unplug the Heating Device and contact your distributor.

6. The Green light (the LED on the left side of the Heating Device) should switch on within 45 minutes.

7. When the Green LED is switched on, the Heating Device is ready for use.* When Green LED is “ON”, Red LED can appear On, blinking or OFF

Preparation

2 3

4 5

6 745

The following disposables are needed for performing the procedure:2ml standard sterile rubber-less syringe x11ml standard sterile rubber-less syringe x21-2ml sterile vial Sterile plastic Pasteur pipetteSperm medium: 0.8ml of an approved/cleared sperm medium as commonly utilized in sperm separation procedures is needed.

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3. The Procedure

NOTE: • Allow semen sample to liquefy between 30-45 minutes after ejaculation prior to beginning the procedure• It is critical that the spermatozoa are separated from the seminal plasma within 1 hour of ejaculation• Use protective measures for working with body fluids

8. Take a Pasteur pipette for semen sample homogenizing. Squeeze the pipette outside the semen container. Insert its edge into the sample. Pump gently while drawing the semen sample into the pipette. Repeat the process 10 times carefully. Avoid pumping air bubbles into the semen sample and pipette!* If the semen sample is still viscous, repeat the process gently for additional 20 times. Check again for viscosity and repeat the process if necessary. Avoid creating bubbles or foam.

10. Open the Seaforia™ Lab Kit.Connect the Lotus Bio™ Tip to the syringe.

9. Use a syringe to measure the correct volume of semen sample, read the volume as measured at the syringe’s piston.

11. Place the Seaforia™ separator in a cavity on the Heating Device/Stativ. Confirm that the separator is aligned properly.

12. Insert the syringe containing the semen into the central opening of the separator marked [ ]. Gently and slowly deposit the semen into the separator using the syringe. Loading the semen should take at least 20 seconds.

In case 0.1ml semen volume is missing from the separator’s volume, complete the missing volume with 0.1ml medium directly to the separator through the medium (M) opening. Adding medium to complete the required volume should be after the deposition of the semen sample into the separator. * Completion of semen volume by medium should not be performed for more than 0.1ml volume.

Loading the Semen Sample

Loading the Medium

14. Insert the syringe to the [M] peripheral opening of the separator and slowly deposit the medium into the separator. Loading the medium should take at least 20 seconds.15. Incubate the separator: a. For IVF 15-30 minutes b. For IUI 30 minutes During this time the motile sperm cells will swim towards the sperm medium.

13. Connect second tip to a new syringe. Draw 0.8ml medium into the syringe.

Drawing Out the Medium Containing Sperm CellsConnect the third tip to the new 1ml syringe.16. Insert the syringe into the peripheral opening [M] until it reaches the bottom of the separator’s compartment. Do not force the syringe further. Gently draw the end product medium with harvested sperm cells (very slowly to improve results). Make sure to draw all medium volume until bubbles appear, and transfer gently to a vial.

In order to measure the correct volume, read the volume as measured at the syringe’s piston.

8Homogenization

720

Draw mediumslowly

16

Different volume separators are intended for sperm separation of 0.5ml/1ml/1.5ml semen sample accordingly.

Draw sample

Read volume

Marked openings

Draw medium Read volume

Load medium Wait 15-30 min

10Place separator11

11Load sample12

13

14 15

Procedure

Open the Lab Kit

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NOTE: In case the entire syringe is filled with medium and without bubbles, perform the procedure again with this end product utilizing a new separator.

* In case the semen volume in the syringe is more than the separator’s volume, deposit access semen volume back to the container.

Connect the tip

IVF IUI

In case the procedure planning requires utilizing more than one separator, repeat the following steps (11-16) for additional separators.

According to the semen volume, decide which separator/s are needed for the procedure.

Procedure Planning

NOTE: In case 0.1ml semen volume is missing from the separator’s volume, complete the missing volume with up to 0.1ml medium directly to the separator through the medium (M) opening.

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Disposing, Disinfecting, Packing and Storing the SeaforiaTM System

17. Dispose all components used for this procedure.

4. AppendixTechnical Specifications of SeaforiaTM Sperm Separation System:

SeaforiaTM Sperm Separation Heating Device:

Power source: USB Adaptor / USB Outlet Required adaptor input: 110 - 240 VAC (EU standard plug)Rating frequency: 50 - 60 HzOutput: 5.0 VDC ± 5%, 1000mADimensions: 102mm x 102mm x 90mmStorage environment: - 4.0oC - 40.0oCWorking environment: 20.0oC - 37.0oC, RH 90% non-condensing Indoor laboratory / office / clinicHeating: Ready for use: 45 min after power switched onIndication: Green LED indicating: “Ready for use” Red LED indicating: “Warming up”

Standards Compliance• IEC 60601-1 (1988) + A 1 (1991); A2 (1995) / EN 60601-1:1990+A1:1993+A2:1995+A13:1996 Medical electrical equipment - General requirements for safety – Safety requirements for medical electrical systems• IEC 60601-1-2 (2007) Medical electrical equipment –1. General requirements for safety , 2. Collateral Standard Electromagnetic compatibility • ANSI/AAMI/ISO 14971 Medical devices - Application of risk management to medical devices (2007)• AAMI HE74:2001 Human factors design process for medical devices• BS EN 980:1997 Graphical symbols for use in the labeling of medical devices

Symbols to convey information essential for proper use

SeaforiaTM Sperm Separation Lab KitEU Authorized Representative: MEDNET GmbH, Borkstrasse 10, 48163 Münster, Germany.Manufactured by: Lotus Bio Inc.www.lotusbio.com

oria.bensaber@bluewin.chLiV SWISS NATURA, Switzerland.

,+41 76 241 16 11, Seaforia Authorized Distributor - Oria Bensaber

CAT10138 Rev 7.1 29/03/2019 Copyright © 2009 Lotus Bio

Inc.. TM

SeaforiaTM Sperm Separation Lab Kit:

Maintenance: Single use, low bio-burden

Glossary

ProcedureA

ppendix

0.10.2

0.30.4

0.50.6

0.70.8

0.91.0

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Cleaning and disinfecting the Heating Device should be in accordance with local regulations for working with body fluids.Use protective measures and thoroughly clean and disinfect the device.

Store in a cool dry place, away from direct sunlight.

CE MARK