Material included in the package: Material not included in

Material included in the package: • 1vialof20mlSpermStore

Material not included in the package:• Spermfreezingstraws

• Sterilepipettes

• Freezingtankwithliquidnitrogen

• LAF-bench(ISOClass5)

Product code:• 4SCP-20

Composition:• GM501SpermStore is a ready-to-

useHEPESbufferedcryopreserva-tion medium which also containsphysiologicsalts,glycine,dextrosemonohydrate, lactate,glycerol,su-crose and human serum albumin(3.95g/Liter)toprotectspermfromdamageduetothefreezingproce-dure.

Intended use/Intended users:• GM501 SpermStore is a medium

forfreezinghumanspermincludingepididymalortesticularsperm.

• TheintendedusersareIVFprofes-sionals (labtechnicians,embryolo-gistsormedicaldoctors).

GM501 SpermStore and Spermpreparation:• GM501SpermStorecanbeusedin

combinationwithGM501Gradient.

Instructions for use:• Ensureallmediaarewellmixedbe-

foreuse.

pH7.20-7.90(Releasecriteria:7.20-7.60)

Sterilitysterile-SAL10-3(SterilityAssuranceLevel)

Endotoxins(EU/ml)<0.25

Spermsurvivaltest(%)≥80survivalafter4hours

exposureofuntreatedsementothetestmedium

Before freezing:• Incaseofverylowspermconcentrationsitisadvisable

toconcentrate thespermbefore freezing.Thismay in-crease spermquality after thawing andwill reduce thenumberofstrawstobefrozen.

• GM501SpermStoreneedstobewarmedtoroomtempe-raturebeforeusetoavoidcold-shock.

Freezing:1. Allow the semen to liquefy at room temperature for 30

minutes.

2. Mix 1ml of spermwith 0.7ml ofGM501SpermStore.Addthemediumindropswhilegentlyswirling.

3. Leave themixture for 10minutes at room temperatureforequilibration.

4. Aspirate the sample/medium mixture into the freezingstraws, leaving approximately 1.5 cmof air at the endofthestraws.

5. Sealthestraws.

6. Dryoffindividuallywithalint-freewipe.

7. Shaketomovetheair-bubbletothecentreofthestraw.

8. Freezevertically for15minutes, justabove the leveloftheliquidnitrogen.

9. Storeinliquidnitrogen.

Thawing:1. Removeasmanystrawsasrequiredfromthe liquidni-

trogen.

2. Placethesamplesintapwaterfor5minutes.

3. Cutofftheendofthestraw,placetheopenendinsidea container (e.g. a test tube) and tap the straw lightlyagainstthesideofthecontainertoallowcompleteeva-cuationofthemixture.

4. Dilutethethawedsperminasuitableinseminationmedium(atleast3mlper0.5mlsemen)andmixthoroughly.

5. Centrifugefor15minutesat300-350xg.

6. Resuspendpelletinasuitableinseminationmedium.

After thawing:• Ifnecessary,usespermpreparationtechniquesafterthaw-

ingthesementoeliminatedeadspermcellsanddebris.

Product specifications and quality control:• All rawmaterialsareofhighestavailablepurity (European

Pharmacopoeiaand/orUSPstandard)ifapplicable.

• A certificate of analysis is available for each batch uponrequestfromourwebsitewithrespectivelotnumber.

• TheMSDS for themedia are available upon request andcanalsobedownloadedfromourwebsite.

• GM501SpermStoreismanufacturedandtestedaccordingtothefollowingspecifications:

GM501 SpermStore GYNEMEDEN

Consultinstructionsforuse

Temperaturelimitation

Lotnumber

Useby

Cataloguenumber

Donotuseifpackageisdamaged

Sterilizedusingasepticprocessingtechniques(filtration)

Keepawayfromsunlight

For technical support:

GYNEMEDMedizinprodukteGmbH&Co.KG, LübeckerStraße9,23738Lensahn-Germany Phone:+49(0)4363903290-Fax:+49(0)4363903291-9 E-mail:info@gynemed.de-http: //www.gynemed.de

Gebrauchsanweisung:GM501_SpermStore:Gebrauchsanweisung_GM501_SpermStore_EN_Rev06_00.inddStand:2017-03-23

Precautions and warnings:• Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalpro-

ductspreparedfromhumanbloodorplasmaincludeselectionofdonors,scree-ningof individualdonationsandplasmapools forspecificmarkersof infectionandtheinclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Despite this,whenmedicinalproductsprepared fromhumanbloodorplasmaareadministered, thepossibilityof transmitting infectiveagentscannottotallybeexcluded.Thisalsoappliestounknownoremergingvirusesandotherpathogens.Therearenoreportsofprovenvirustransmissionswithalbumin,ma-nufacturedtoEuropeanPharmacopoeiaspecificationsbyestablishedprocesses.

• Therefore, handle all specimens as if capable of transmittingHIV or hepatitis.Alwayswearprotectiveclothingwhenhandlingspecimens.

• Productdoesnotcontainanyantibiotics.Alwaysworkunderstricthygieniccon-ditions(e.g.LAF-benchISOClass5)toavoidpossiblecontamination.

• Onlyfortheintendeduse.

Pre-use checks:• Donotusetheproductifbottle,sealofthecontainerorpackageisopenedor

defectwhentheproductisdelivered.

• Donotusetheproductifitbecomesdiscoloured,cloudyorshowsanyevidenceofmicrobialcontamination.

Storage instructions and stability:• Theshelflifeis18monthfromtimeofmanufacture.

• Storebetween2-8°C.

• Donotfreezebeforeuse.

• Keepawayfromsunlight.

• Afteropeningthecontainerdonotusetheproductlongerthan7days.

• Donotuseafterexpirydate.

• Stableaftertransport(max.5days)atelevatedtemperature(≤37°C)

0344

GYNEMEDGM501 SpermStore EN