How to use Covid-19, Flu A/B and RSV Rapid Antigen Test | TGA App.
TouchBio | Premium Rapid Antigen Tests & Hygiene and DisinfectantsHow to use Covid-19, Flu A/B and RSV Rapid Antigen Test | TGA App.
Instruction Manual for touch BIO models including: VMD71 RSV FLU A-B and Covid-19 Rapid Antigen Combo Test, VMD71, RSV FLU A-B and Covid-19 Rapid Antigen Combo Test, Covid-19 Rapid Antigen Combo Test, Rapid Antigen Combo Test, Antigen Combo Test, Combo Test
8 mag 2023 — Insert the sampled swab into the extraction buffer tube, and dip the tip into the tube. Rotate the swab tip 10 times along the inner wall of the buffer tube ...
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DocumentDocumentTEST PROCEDURE TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) REF: VMD71 An Antigen Rapid Test for the detection of SARS-CoV-2, Flu A/B and RSV in nasal swab. For Self-Testing use. Read the instructions carefully before taking the test. IMPORTANT Australia Sponsor & Distributor Touch Biotechnology Pty Ltd STEP-1 Wash your hands Wash or clean your hands and make sure they are dry before starting the test. After washing your hands, open the box, and check the components before use. STEP-2 Read Instructions for use Read instructions for use carefully before using the test. Customer Support Number: 1300 166 282 STEP-3 Place the buffer tube into the holder Hours: 9am-7pm (AEST), or 9am-8pm (AEDT), 7 days per week Website: www.touchaustralia.com.au Email: touch@touchaustralia.com.au Carefully place extraction tube into tube holder or tube stand. Address: 119 Willoughby Road, Crows Nest, NSW 2065 Open the lid. Watch "How to Use Video" Scan the QR code for information on how to use the test. DO NOT DRINK the extraction buffer liquid. If you accidentally drink it IMPORTANT immediately consult your healthcare professionals. DO NOT SPILL any of the extraction buffer liquid. If you spill it, sterilize the area, and repeat the test by using new sampling swab and extraction solution tube. RSV SARS-CoV-2 FLU A/B C C C A T T B 15 x3 x3 x3 S S S Test Cassette (Device) White Cap Lid Sterilized Swab Buffer Liquid Extraction Buffer Tube Instructions for Use Component required but not provided. Tube Stand Biohazard Only 20 tests/kit package contains the tube stand. The other test kits Specimen Bag have a holder for the tube. STEP-4 Take the sterilized swab Pull open the swab packaging at the marked point and remove the swab. Soft Head of Swab DO NOT TOUCH soft head of swab. DO NOT OPEN the swab until you are going to IMPORTANT use it immediately. STEP-5 Sample Collection Tilt your head back slightly LEFT NOSTRIL Gently insert the swab about 2cm into the left nostril. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Do the same for the right nostril Gently insert the swab about 2cm. At least with the entire soft swab. Gently rotate the swab at least 5 times against the nasal wall. Remove the swab from the second nostril. 2 cm Rotate 5 times RIGHT NOSTRIL 2 cm Rotate 5 times IF YOU FEEL DISCOMFORT, STOP IMMEDIATELY. IMPORTANT If the swab stick breaks during the sample collection, please use a new swab. Do not insert the swab deeper if you feel strong resistance or pain. STEP-6 Insert the swab Rotate 10 times Squeeze it 5 times Insert the sampled swab into the extraction buffer tube, and dip the tip into the tube. Rotate the swab tip 10 times along the inner wall of the buffer tube. And squeeze the tip of the swab 5 times along the inner wall of the tube to keep as much liquid in the bottle as possible. . STEP-7 Take out the swab Remove the swab from the tube by squeezing the sides of the tube to release the liquid from the swab. IMPORTANT If squeezing of tube is not done correctly, sample swab absorbs much more liquid form the extraction buffer and that will yield wrong results. Discard the swab in the biohazard specimen bag. STEP-8 Close and Mix the tube Squeeze it STEP-10 Unscrew the white cap Unscrew the white cap of the tube. White Cap This allows drop-wise dispensing of the liquid. Turn up STEP-12 Wait for result Set timer and wait for 15 15 minutes. Wait for 15 minutes STEP-11 Test Operation Add 3 drops of the extraction buffer tube to the FLU A/B sample well marked "S" on the test cassette. Read the result at 15-20 minutes. Read at 15-20 Minutes DO NOT READ the result beforehand or after 20 minutes, even If a line has already appeared at the region "C" IMPORTANT Screw on and tighten the lid on the extraction tube. And then shake the extraction tube vigorously to mix the specimen and the sample extraction buffer. Ensure the lid is screwed on properly. Do not spill any of the sample extraction liquid. IMPORTANT STEP-9 Take out the cassette Open the foil pouch and take out the test cassette. Place it on a flat and clean surface. FLU A/B Sample Well. S x3 B A C STEP-13 Read your results 15 x3 S C T x3 S C T To read your test results, please go to the interpretation of the results Do the same for the SARS-CoV-2 sample well marked "S, add 3 drops. section provided below. S S S SARS-CoV-2 Sample Well. Do the same for the RSV sample well marked "S, add 3 drops. x3 x3 x3 15 B T T A C C C STEP-14 Disposal Please dispose all parts of the test kits and place them in the biohazard bag that can be disposed in the household waste or rubbish bin. If there are local regulations, please follow them. STEP-15 Wash your hands RSV SARS-CoV-2 FLU A/B RSV SARS-CoV-2 FLU A/B RSV SARS-CoV-2 FLU A/B RSV SARS-CoV-2 FLU A/B C C C A T T B 15 x3 x3 x3 S S S Result window Sample well Perform the test within 15 minutes 15 after the foil pouch is opened. min. IMPORTANT RSV Sample Well. S S S x3 x3 x3 15 B T T A C C C Wash your hands thoroughly after test completion. Ensure to add at least 3 drops of the liquid from the specimen tube into the each sample well. IMPORTANT If adding less than 3 drops, that will yield wrong result. Watch "how to use" video: touchaustralia.com.au/pages/ifu-covid-flu-rsv INTERPRETATION OF THE RESULTS POSITIVE RESULTS EACH TEST WINDOW (FLU A/B, SARS-CoV-2 AND RSV ) MUST BE READ INDEPENDENTLY FROM EACH OTHER. NEGATIVE RESULTS INVALID RESULTS FLU A/B FLU A/B FLU A/B SARS-COV-2 RSV C C C C C A A A T T B B B FLU A FLU B FLU A+ B SARS-COV-2 RSV Positive Positive Positive Positive Positive THE SHADE OF LINES MAY VARY, BUT EVEN IF A FAINT/WEAK LINE APPEARS, IT SHOULD BE CONSIDERED POSITIVE. If you have a POSITIVE result, follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance for SARS-CoV-2 and individuals with a positive result or who are unwell must consult a medical practitioner for follow-up clinical care for Influenza and RSV. FLU A/B C A B SARS-COV-2 C T RSV C T FLU A/B Negative SARS-COV-2 Negative RSV Negative ONLY RED LINES APPEAR IN THE CONTROL REGIONS (C), AND NO LINE IN THE REGION (A), (B), AND (T). The negative result indicates that there are no Flu A/B, RSV and SARS-CoV-2 particles in the sample or the number of viral particles is below the detectable range. Even if you get a negative result, you still need to follow all public health advice on limiting the spread Covid-19, Flu A/B and RSV. If symptoms persist, repeat testing and consult a medical practitioner for follow-up clinical care. FLU A/B INVALID C C C C A A A A B B B B SARS-CoV-2 INVALID RSV INVALID C C T T C C T T NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR FLU A/B. The test is invalid even if there is a line on the region (A), (B) or (A) and (B). NO RED LINE APPEARS IN NO RED LINE APPEARS IN THE CONTROL REGION (C) THE CONTROL REGION (C) FOR SARS-COV-2. FOR RSV. The test is invalid even if there The test is invalid evenif there is a line on the region (T). is a line on the region (T). WHEN NO RED LINE APPEARS IN THE CONTROL REGION (C) FOR ALL THREE TESTS, THE TEST IS INVALID FOR ALL THREE FLU A/B, SARS-COV-2 AND RSV. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line (C) failure. Review the test procedure and repeat the test using a new test device. If invalid result continues after repeating, please contact Touch Biotechnology on the provided contact number or email for assistance. NEED HELP with the TEST? Before You Start Do not open the foil pouch and swab packaging until you have read the instructions, and are ready to take the test. Use immediately upon opening. Will this test hurt? No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a doctor. When should I perform the test after opening the foil pouch? You should perform the test within 15 minutes after opening the foil pouch. Don't know how long I should keep the swab out without using? Do not open the swab packaging until you are going to use it immediately. What do you need to consider when storing the test kit? You can store the test kit at 2°C - 30°C temperature. Do not freeze and do not store the test kit in direct sunlight. All components must be bought to room temperature before testing. Do not use after expiry date. Sample Collection Do I need to insert the swab into my both nostrils to take sample? Yes, you must take the samples from your both nostrils. Test Operation How many drops should I add in both sample wells? You should add 3 drops using the buffer tube into all three samples wells noted as "S" on the cassette Don't know how long I should wait to read my results? Make sure you wait for 15 minutes, and then read your results at 15-20 minutes Read Results How do I know if the test was run properly? A coloured line will appear in the control region (C) of the test cassette if the test has been properly performed. If this line is not visible, then the test has been incorrectly performed and you must run a new test or call customer support. There is a faint/weak line appearing at A, B or T, should this be still considered as positive? Yes, even if there is a faint line at the region A, B or T or all, results must be considered as positive. The red line appeared in the control (C) region only on some of the strip/s and did not appear on one or two strips. Does that mean the test is invalid for all 3 viruses? No, it means test must be considered invalid only for those virus where red line is absent on control (C) region. Results are valid for any test where control region (C) is present. Don't know how deep I should insert the swab into my nostrils? Gently insert the swab about 2cm (soft head of the swab) into your nostrils.Do not insert the swab deeper if you feel strong resistance or pain. Visit www.touchaustralia.com.au/pages/ifu-covid-flu-rsv to watch "how to use" video. If you have any specific questions, feedback or suggestion,please contact us on the provided contact number or email address. TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) REF: VMD71 An Antigen Rapid Test for the detection of SARS-Cov-2, Flu A/B and RSV in nasal swab. For Self-Testing use. In-vitro diagnostic test for self-testing Instructions for use INTENDED USE TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is an in vitro immunochromatographic assay for the qualitative detection of antigens in nasal swab specimens collected from patients against the respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This test is intended for use as an aid in the differential diagnosis of SARS-CoV-2 and influenza A/B or Respiratory syncytial virus (RSV) viral infections in humans in conjunction with clinical and epidemiological risk factors. The test does not require any special training for sample collection, processing, or test operation. TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is intended to be used by laypersons as a self-test. The test can be performed by individuals older than 18 years old and users between 4-18 years old required guidance by adults. This kit is not suitable for children under 4 years old. PRINCIPLE OF THE TEST TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is an immunochromatographic membrane assay and contains 3 independent tests, the SARS-CoV-2 antigen test, FLU A/B antigen test and RSV antigen test. In the test procedure, a specimen is collected by nasal swab and placed onto sample well of test cassette as 3 drops then allow the solution in the sample well to migrate through the pads containing highly sensitive detector antibodies conjugated to gold dye for detection of nucleocapsid antigens. MATERIALS AND COMPONENTS Materials required and provided with the test kits COMPONENT 1 TEST KIT 2 TESTS KIT 5 TESTS KIT 20 TESTS KIT Test Device 1 Test cassette 2 Test cassettes 5 Test cassettes 20 Test cassettes (1 Test/pouch x 1 pouch) (1 Test/pouch x 2 pouches) (1 Test/pouch x 5 pouches) (1 Test/pouch x 20 pouches) Extraction Buffer Tube 1 single-use bottle, each with 500 µL extraction buffer 2 single-use bottles, each with 500 µL extraction buffers 5 single-use bottles, each with 500 µL extraction buffers 20 single -use bottles, each with 500 µL extraction buffers 1 sterile, single use Sterilised Swab specimen sampling swab 2 sterile, single use specimen sampling swabs Biohazard Specimen Bag 1 biohazard specimen bag 2 biohazard specimen bags Instructions For Use Tube Stand 1 instructions for use 1 instructions for use - - 5 sterile, single use specimen sampling swabs 20 sterile, single use specimen sampling swabs 5 biohazard specimen bags 20 biohazard specimen bags 1 instructions for use 4 instructions for use - 1 Tube Stand Materials required but not provided with the test kit -Timer STORAGE AND STABILITY 1. Store the test kit at 2°C - 30°C. DO NOT FREEZE and DO NOT STORE the test kit in direct sunlight. All components must be brought to room temperature before testing. 2.The test cassette must be used within 15 minutes after removal from the foil pouch. 3. DO NOT USE after the expiry date. The expiry date is stated on the label/packaging. LIMITATIONS 1. Each test can only be used once 2. Test results must be read at 15 minutes and no later than 20 minutes. 3. A negative result does not rule out infection with another type of respiratory virus (other than SARS-Cov-2, Influenza A/B and RSV). 4. A negative result does not mean a person is not infectious or does not have COVID-19, Influenza A/B or RSV. If symptoms persist the person should seek medical attention and further testing if required. 5. Positive test results do not rule out bacterial infection or coinfection with other viruses 6. A false negative test may result if the level of antigen in the sample is below the detection limit of the test or if the sample was collected incorrectly. 7. If the result is positive for SARS-CoV-2, please contact the relevant state or territory health authority for guidance on confirmation testing. 8.If positive for Influenza A/B or RSV are feeling unwell, consult a medical practitioner for follow-up clinical care.. 9. The test is less reliable in the later phase of infection and in asymptomatic individuals. 10. Children aged 4-18 years old should have the samples collected and tested by an adult. Do not use on Children under 4 years of age. 11. False negative results are more likely to occur if the test is performed after 7 days of symptom onset for SARS-CoV-2 and after 4 days of symptom onset for Influenza A/B and RSV. 12. Even if the result is negative, you still need to observe all protective and hygienic measures, 13. Repeat Testing is recommended (between 24-48 hours after your first test if there is ongoing suspicion of infection, being high risk settling or where there is an occupational risk or other requirement. 14. Influenza and RSV self-testing is for use as an aid for diagnosis only and individuals with a positive result or who are unwell are advised to consult a medical practitioner for follow-up clinical care. QUALITY CONTROL A colored line in the control area (C) is considered an internal process control. It confirms complete penetration of the membrane with the sample, reactivity of the reagents, and correct test performance. PERFORMANCE CHARACTERISTICS Clinical Study Performance The clinical performance of the kit was determined by comparison with an RT-PCR assay. Individual kits used in the clinical performances included combination antigen rapid test for COVID-19+FLU A/B and antigen rapid test for RSV. Samples were taken within first 4 days of symptoms onset for Influenza A+B, RSV and samples taken within 7 days of symptoms onset for SARS-CoV-2. The performance of the kit was assessed with 261 positive SARS-CoV-2 case, 223 positive cases of RSV 160 positive Influenza A case, and 120 positive influenza B case by nasal swabs. TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Results for Influenza A: The sensitivity is 98.39% and the specificity is 100.0%. The accuracy of the test kit is calculated as 99.21%. RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Positive Negative Total RT-PCR comparison method Positive Negative Total 183 0 183 3 195 198 186 195 381 Results for Influenza B: The sensitivity is 98.86% and the specificity is 100.0%. The accuracy of the test kit is calculated as 99.46%. RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Positive Negative Total RT-PCR comparison method Positive Negative Total 174 0 174 2 195 197 176 195 371 RSV: TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Positive Negative Total Sensitivity Specificity Accuracy Positive 220 3 223 98.65% 99.57% 99.12% RT-PCR comparison method Negative Total 1 221 230 233 231 454 95% CI 96.12% to 99.72% 95% CI 97.61% to 99.99% 95% CI 97.76% to 99.76% Usability Study Performance A total of 778 layusers took part in the TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) study. Results are summarized below. Results for SARS-CoV-2: The sensitivity is 98.28% and the specificity is 99.49%. The accuracy of the test kit is calculated as 99.04%. RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Positive Negative Total RT-PCR comparison method Positive Negative Total 114 1 115 2 194 196 116 195 311 Results for RSV: The sensitivity is 97.14% and the specificity is 99.49%. The accuracy of the test kit is calculated as 98.67%.. RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test Positive Negative Total RT-PCR comparison method Positive Negative Total 102 1 103 3 194 197 105 195 300 Analytical Performance 1.Limit of Detection (LOD) The minimum detection limit of the TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) is 100 TCID50/mL for SARS-CoV-2 infections. For Influenza A, the detection limit is minimum 1.0x102 TCID50 /mL (A/Victoria/3/75) and maximum 5.0x104 TCID50/mL (A/ HK/403946/09) and for Influenza B, the detection limit is minimum 6.0x10² TCID50/mL(B/1704) and maximum 4.0x104 TCID50/mL (B-Yamagata). For RSV, the detection limits is 240 TCID50/mL. 2.Variants 2.1.SARS-CoV-2 B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.617.2 (Delta), B.1.1.529 (Omicron). 2.2 Influenza A variants H1N1, H3N2, H1N1pdm09, A/Taiwan/42/06, A/HongKong/8/68, A/Victoria/3/75, A/14160, A/HK/403946/09, A/44045, A/924, A/Beijing/302/54, A/swine/ Guangdong/2/01, S-OIV A/HK/415742/09, S-OIV A/California/4/09. In silico analysis: 6.The sample buffer and test cassette must be brought to room temperature For Human Coronavirus HKU1, homology exists between the SARS-COV-2 (18°C~30°C) before use, otherwise the results may be false. nucleocapsid protein and Human Coronavirus HKU1. Blast results showed 7.Discard and do not use any damaged or dropped Test Card or material. 36.6% homologous across 82% of the sequence. 8.Users should test specimens as soon as possible after collection This is relatively low but cross-reactivity cannot be fully ruled out. if the sample does not store in sample extraction solution. Blast results showed no homology or sequence similarity between RSV 9.Do not spill any of the sample extraction solution. If you spill it, sterilize 2.3.Influenza B variants sequenece and HKU1, Mycobacterium tuberculosis & Pneumocystis the area and if the amount of the sample extraction solution mixture is not B-Victoria, B-Yamagata, B/1715, B/1704, B/179, B/668, B/Taiwan/2/62, jirovecii. enough to perform the test, repeat the test bey using new sampling swab B/ Malaysia/2506/2004. and extraction solution tube. 2.4.Respiratory syncytial virus (RSV) Variants RSV A and RSV B. 3.2.Interference Substances The test results are not interfered by the substance in the following concentration. Whole Blood, Mucin, Benzocaine, Menthol, Zanamivir 10.Do not drink the extraction solution in the tube with or without swab. Immediately consult your healthcare professional if you drink it. 11.If the sample volume is insufficient, the assay will not perform Mupirocin, Tobramycin, Fluticasone, Beclomethasone, Dexamethasone, successfully. 3.Analytical Specificity Flunisolide, Triamcinolone, Mometasone, Sodium Chloride with preservative, 12.The Reagent Solution contains a salt solution (saline). If the solution 3.1.Cross Reactivity Phenylephrine, Afrin (Oxymetazoline), Ibuprofen, Tetracycline, contacts the skin or eye, flush with copious amounts of water. The cross-reactivity of the kit was evaluated. The results showed no Chloramphenicol, Erythromycin, Arbidol, Ribavirin, Histamine 13.Inadequate or inappropriate storage and transport of all components cross-reactivity with the following samplesthe following samples. dihydrochloride, Throat spray (Menthol), Mupirocine, Ice throat candy and sample collectionmay yield false test results. Adenovirus Type 3, Adenovirus Type 5, Adenovirus Type 7, (Menthol), Tamiflu (Oseltamivir), Naphazoline hydrochloride nasal drops, 14.To obtain accurate results, do not use visually bloody or overly viscous Human Parainfluenza Type 1,Human Parainfluenza Type 2, Human Fisherman's Friend, Cromoglycate, Sinex (Phenylephrine Hydrochloride), specimens. Parainfluenza Type 3, Human Parainfluenza Type 4, Human coronavirus Fluticasone propionate spray, Chloraseptic (Menthol/ Benzocaine), 15.To obtain accurate results, an opened and exposed Test Card should not OC43, Human coronavirus NL63, Human coronavirus 229E, Respiratory NasoGEL (NeilMed), CVS Nasal Spray (Cromolyn), Saline Nasal Spray, be used in a heavily ventilated and moisture area. syncytial virus Type A, Respiratory syncytial virus Type B, Rhinovirus Zicam Cold Remedy, Homeopathic (Alkalol), Sodium Cromolyn Eye 16.Wash hands thoroughly after handling. Type 1,Rhinovirus Type 14, Rhinovirus B70, Enterovirus CA16, Enterovirus Drops, Alkalol Nasal Wash, Throat Lozenge, Sore throat phenol throat 17.Do not touch the sample well or the membrane of the test cassette. 70, Avian influenza virus H7N9, Avian influenza virus H5N1, Human spray. 18.Keep out of reach of children para-flu virus Type 1, Human para-flu virus Type 2, Human para-flu virus Type 3, Human para-flu virus Type 4, Cytomegalovirus, Measles virus, PRECAUTIONS Boca virus, Mumps virus, Epstein Barr Virus, Herpes simplex virus (HSV-1), Varicella-zoster virus, Human metapneumovirus, MERS coronavirus, 1.For self-testing in-vitro diagnostic use only. SARS-coronavirus, Human coronavirus (HKU1), Bordetella pertussis, 2.Do not use the kit contents beyond the expiration date printed on Bordetella parapertussia, Staphylococcus epidermidis, Staphylococcus the outside of the box. aureus, Staphylococcus pneumoniae, Streptococcus pyogenes, 3.Do not reuse the used Test Card, Reagent Tube or Swab. Streptococcus pneumoniae, Streptococcus salivarus, Escherichia coli, Candida albicans, Mycobacterium tuberculosis, Paramyxovirus parotitis, Pneumocystis jirovecii, Moraxella catarrhalis, Pseudomonas aeruginosa, Pneumocystis, Legionella pneumophila, Corynebacterium pneumophila, Lactobacillus pneumophila, Klebsiella pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Neisseria pneumophila, Neisseria meningitides, Haemophilus influenza. 4.The aluminum pouch includes a test cassette and a silica gel. Silica gel is required for protect test cassette against environmental conditions. Do not use the test kit if the aluminum pouch does not include silica gel. Do not swallow the silica gel. When swallowed, immediately consult your healthcare professional. 5.All users must read the instructions for use carefully before carrying out the test. Australia Sponsor & Distributor Touch Biotechnology Pty Ltd Customer Support Number: 1300 166 282 Hours: 9am-7pm (AEST), or 9am-8pm (AEDT), 7 days per week Website: www.touchaustralia.com.au Email: touch@touchaustralia.com.au Address: 119 Willoughby Road, Crows Nest, NSW 2065 Code:RSV-IFU Date of Issue:21.04.2023 Version: 01202303_07