User Manual
Contents
1. CE THEY MAY STICK IN THE TIPAND ORBECOME DAMAGED I Close the inner chamber by rotating the lid clock wise and remove any cell culture medium remaining in the overflow well area above the lid witha pipette 3 Outer rigid shell installation a Open the pre warmed package 2 of 2 containing the outer rigid shell top and bottom parts CAUTION Do not touch the inner surfaces of the outer rigid shell top part during installation b Carefully introduce the inner chamber into the outer rigid bottom part Verify that the small tip at the lower extremity of the inner chamber is positioned in the small cylinder feature located inside the bottom of the outer rigid shell Put pressure on the top of the lid to engage the two containers FIGURE 5 CLOSING THE OUTER RIGID SHELL c Close the outer rigid shell by pushing the top part down on the large o ring with three tabs of the bottom part engaged in the corresponding holes of the top part Turn the top part clockwise to lock the outer rigid shell closed see figure 5 CAUTION Verify that the outer rigid shell is correctly locked before placement of the INVOcell in the vaginal cavity d If necessary place the loaded fully assembled INVOcell see figure 6 in the 37 C incubator until ready for placement in the patient FIGURE 6 FULLY ASSEMBLED INVOcell ae N 4 Intra vaginal placement Rinse the loaded fully assembled INVOcell with water or saline sol2. FG 002 REV 07 INVO Bioscience 100 Cummings Center Suite 421E Beverly MA 01915 USA 1 978 878 9505 Website www invobioscience com Federal law USA restricts this device to sale only by or on the order of a physician
3. INVO PROCEDURE EMBRYO DEVELOPMENT IS FIRST EVALUATED AT THE END OF THE INCUBATION PERIOD WHICH IS 48 72 HOURS POST FERTILIZATION THEREFORE ANY ABNORMALITIES THAT WOULD HAVE BEEN DETECTED AT AN EARLIER STAGE PRO NUCLEI STAGE MAY NO LONGER BE APPARENT WHEN THE EMBRYOS ARE EVALUATED FOR TRANSFER AS A RESULT THERE MAY BE INCREASED RISK THAT AN ABNORMAL E G TRIPLOID EMBRYO COULD BE TRANSFERRED TO THE UTERUS WARNING THE INVOcell IS A SINGLE USE DEVICE REUSE MAY RESULT IN CONTAMINATION WARNING DO NOT RESTERILIZE RESTERILIZATION MAY RESULT IN FAILURE OF THE INVOcell WARNING UTILIZE A CULTURE MEDIUM THAT WILLSUPPORTCONTINUEDE MBRYONIC DEVELOPMENT FOR UPTO3 DAYS WARNING DO NOT INCUBATE BEYOND 3 DAYS WARNING DO NOT USE IF PRODUCT OR PACKAGE APPEARS DAMAGED INSTRUCTIONS FOR USE 1 Pre warm the following in a 37 C incubator for at least 1 hour prior to use e Unopened package 1 of 2 containing the inner chamber e Unopened package 2 of 2 containing outer rigid shell for the inner chamber e INVO Bioscience INVO holding block e Newunopened bottle of cell culture medium 2 Placement of gametes sperm and oocyte a Open the pre warmed package 1 of 2 containing the inner chamber b Place the closed inner chamber in the pre warmed holding block andkeep the outer rigid shell in its package at 37 C Note The inner chamber is pouched in the closed condition see Figure 3a Figure 3a Top view of lid i
4. INVOcell DEVICE INSTRUCTIONS FOR USE Ce INVO Bioscience DEVICE DESCRIPTION The INVO Bioscience INVOcell device is a three part assembly see Figures 1 and 2 enclosed in two separate packages One package contains the inner chamber The other package contains the top and bottom parts of the outer rigid shell The inner chamber holds gametes in cell culture medium and is placed in the vaginal cavity for incubation to allow embryo development prior to the embryo s placement into the uterus The outer rigid shell protects the inner chamber from contamination while in the vaginal cavity FIGURE 1 INNER CHAMBER Contents of Package One Rotating lid Docking position for embryo transfer catheter Inner chamber for medium gametes embryos FIGURE 2 OUTER RIGID SHELL FOR CELL CULTURE CONTAINER Contents of Package Two Top part of outer rigid shell Bottom part of outer Large o ring for rigid shell sealing of the 2 parts INTENDED USE The INVO Bioscience INVOcell is intended for use in preparing storing manipulating or transferring human gametes or embryos for the Intra Vaginal Culture also called INVO procedure MATERIALS The inner chamber is made of polystyrene polypropylene and non latex rubber thermoplastic elastomer TPE with a silicone o ring The outer rigid shell is made of polystyrene with a large silicone o ring Micro chamber INDICATIONS FOR USE The INVO Bioscience INVOcel
5. l is sterile non pyrogenic embryo toxicity tested single use plastic labware intended to prepare store manipulate or transfer human gametes or embryos for the INVO procedure CONTRAINDICATIONS The INVO Bioscience INVOcell should not be used in patients with the following conditions e Demonstrated hypersensitivity to the materials used in the INVO Bioscience INVOcell e Demonstrated vaginal infection recent pelvic surgery or history of toxic shock syndrome e Severe case of vaginismus e Conditions other than those appropriate for treatment using the INVO procedure STERILIZATION The INVO Bioscience INVOcell is provided sterile according to manufacturing procedures that have been validated to meet a sterility assurance level SAL of 10 Do not re sterilize NON PYROGENIC The INVO Bioscience INVOcell is endotoxin tested by LAL yielding no more than 0 5EU ml or 20 EU Vvessel NON EMBRYOTOXIC The INVO Bioscience INVOcell has been tested for embryotoxicity yielding at least 75 of both test and control 2 cell mouse embryos at hatched and or blastocyst stage STORAGE Store at room temperature below 25 C 77 F away from moisture and direct heat Do not use after the expiration date WARNING DO NOT BEGIN CLINICAL USE OF THE INVO BIOSCIENCE INVOCELL LABWARE WITHOUT ESTABLISHING COMPETENCY BY READING AND PRACTICING THESE INSTRUCTIONS FOR USE Micro beads 90um diameter should be used to practice embryo aspirati
6. lock and the cell culture chamber in the incubator for 20 minutes b Place the closed inner chamber horizontally in the microscope viewing port side hole of the holding block with the aligned indicator slots uppermost c Locate the embryo s settled in the bottom of the micro chamber with the microscope see figure 8 The number of embryos resulting from incubation should be compared to the number of oocytes placed inthe inner chamber and differences noted FIGURE 8 MAGNIFIED VIEW OF MICROCHAMBER AS OBSERVED DURING LOADING OF THE EMBRYO TRANSFER CATHETER Docking Air bubble in position catheter lumen d Gently open the lid of the inner chamber by turning it counter clockwise e Introduce the catheter through the opening in the lid into the docking position adjacent to the micro chamber see figure 8 pull gently on the syringe plunger to aspirate the embryo s Note Generally a small air bubble 5 ul is used to separate thecolumn of medium in the catheter from the loaded volume containing embryo s f Withdraw the catheter slowly from the inner chamber and proceed with embryo transfer INVO Bioscience is a Trademark of INVO Bioscience Inc These products are covered by one or more of U S Patents 4 902 286 5 135 865 and 6 050 935 andU S patents pending Corresponding patents in other countries granted or pending Copyright INVO Bioscience Inc 2007 All rights reserved Printed in USA P N
7. n closed position Indicator slots aligned closed position Note In the closed position the indicator slot in the lid is aligned with an identical slot located on the rim of the inner chamber see Figure 3a Figure 3b Top view of lid in open position Lid opening c Turn the lid counter clock wise to open see figure 3 Rinse the inner chamber with pre warmed culture medium using an adjustable volume pipette to add and remove medium through the circular opening in the lid see Figure 4 d the volume of the inner chamber is 1 08 ml Using a sterile glass pipette or a pipette with a long thin plastic tip fillthe inner chamber with pre warmed culture medium FIGURE 4 FILLING THE INNER CHAMBER Pipette filled with culture medium Inner chamber in holding block Close the inner chamber and aspirate the culture medium in excess in the overflow well Turn the inner chamber upside down to verify the absence of major air bubbles If necessary eliminate any trapped air bubbles filling the micro chamber Reopen the chamber Using an adjustable volume pipette with a 0 200 ml tip transfer 30 000 motile sperm into the inner chamber The added volume is generally under 50 ul Using a glass pipette or an adjustable volume pipette witha 250 1000 ul tip transfer oocytes into the inner chamber The added volume should not exceed 50 ul WARNING DO NOT USE A 0 200 uL TIP TO ADD OOCYTES SIN
8. on from the cell culture container If you have questions regarding use of the INVO Bioscience INVOcell or the INVO procedure contact INVO Bioscience customer assistance by e mail INVO Bioscience at clauderanoux invobio com REQUIRED ACCESSORIES The following equipment and supplies or equivalent are required to facilitate use of the INVO cell e Laminar flow workstation e 37 C incubator e Stereo microscope e Bench centrifuge e Adjustable volume pipettes covering 5 1000u1 and sterile pipette tips e Complete P 1 medium with SSS Irvine Scientific cat 9926 or other medium approved to support embryo development for 3 days e Embryo transfer catheter Wallace Cooper Surgical cat ME1816 Cook cat K J SPPE681700 Frydman Fertility Technology Resources cat 13070S0 and I ml syringe WARNING DO NOT USE OTHER EMBRYO CATHETER MODELS WITHOUT CHECKING THAT THEY FIT IN THE DOCKING POSITION APPROPRIATELY AND DO NOT TOUCH THE BOTTOM OF THE MICROCHAMBER e Powder free gloves e INVO Bioscience INVO holding block for the inner chamber sold separately The specially designed holding block accessory acts as a passive thermal mass while physically stabilizing the inner chamber temperature during various stepsofthe process including microscopic visualization of embryos This block is provided not sterile and should be cleaned to the standard of the microscope base and microscope per the laboratory procedure WARNING IN THE
9. t the patient not to remove the INVOcell from the vaginal cavity and to avoid manipulation of the INVO cell CAUTION Provide the patient with instructions for replacement of the INVOcell in the event it moves from its original position 7 Removal of the INVO Bioscience INVOcell a After incubation pull with your finger on the rigid external ring of the retention device the INVOcell will automatically follow and remove them from the vagina longitudinally b Rinse the INVOcell with pre warmed saline solution and wipe with gauze to remove excess vaginal secretions c Holding the vessel upright open the outer rigid shell by turning the top part counter clockwise Remove the inner chamber Then discard the outer rigid shell CAUTION If obvious contamination of culture medium is observed the embryos should be discarded d Place the inner chamber vertically in the upright position in the pre warmed holding block Place the holding block in the incubator 8 Embryo Sedimentation Leave the inner chamber in the incubator for fifteen minutes During this period the embryo s will settle into the micro chamber located at the bottom of the inner chamber 9 Embryo transfer catheter location loading of the embryo a Setup the catheter for loading the embryos CAUTION Observe and record the starting time of step 9b If loading the embryo transfer catheter takes more than 10 minutes re warm the holding b
10. ution pre warmed to 37 C and insert it longitudinally in the vagina Push deep into the vaginal channel and then rotate 90 degrees in the horizontal plane to position in the posterior formix behind the cervix see figure 7 FIGURE 7 PLACEMENT OF THE VESSEL IN THE FORNIX 5 Adiaphragm with holes in the membrane is a retention device and should ell also be placed in the vagina to maintain the INVOcell device in the vaginal cavity Note It is easier to position the INVOcel and the retention device at the same time in vaginal cavity by placing the INVOcellin the membrane of retention device CAUTION Use of the retention device may result in discomfort CAUTION In the event the patient is intolerant of the retention device the INVOcell device may be placed without the retention device In this case the patient should be informed ofthe need to take special precaution to prevent expulsion during activities such as urination and bowel movement see patient instructions 6 Period of Vaginal Incubation Incubate the INVOcell in the patient s vagina for 2 or 3 days WARNING DO NOT INCUBATE BEYOND 3 DAYS CAUTION Advise the patient to avoid the following activities during INVO with the INVO Bioscience INVOcell swimming bathing in a tub a shower is permissible sauna sexual activity strenuous activity of any type CAUTION Instruct the patient to contact the physician if any discomfort is felt CAUTION Instruc
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