Ambu I.V. Trainer Directions for Use Ver 1.3.0

English Directions for use

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Deutsch Bedienungsanleitung

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Français Mode díemploi

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Español Manual de instrucciones

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Italiano Manuale díuso

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Português Manual de instruções

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Dansk Brugsanvisning

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Svenska Instruktionshandbok

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These directions for use may be updated without futher notice. Copies of the current version are available from the manufacturer. 2

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Contents Introduction Specifications Description Preparation Using the Ambu I.V. Trainer Cleaning Removing and replacing the arm Maintenance Accessories and spare parts

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Ambu® are registered trademark of Ambu A/S, Denmark. Ambu is certified according to ISO 9001 und ISO 13485. 3

1. Introduction The Ambu I.V. Trainer is designed to enable demonstration of and training in the following procedures: • Insertion of needles and cannulas • Injection of medication • Infusion of fluids • Blood sampling • Pulse-taking - the pulse can be simulated by the instructor The I.V. Trainer is provided with a renewable skin as well as three renewable veins and one artery. The veins and artery are provided with indicators to show change of colour during injection and infusion. The hand is joined to the arm by a flexible wrist. The forearm can be turned through 180º at the elbow joint. The fluid reservoir is incorporated into the upper arm, and the I.V. Trainer is designed with a valve system to prevent air pockets from developing in veins and artery. The I.V. Trainer may be mounted on the Ambu Man CPR manikin, or used as a selfcontained arm attached to a washable underlay which also serves as a storage bag and carry case. The following items are supplied with the l.V. Trainer: 1. 5 ml syringe for fluid mixing 2. 50 ml syringe for filling of reservoir 3. Bottle of red dye concentrate 4. Bottle of talcum 5. Overflow tube 25 cm The following items should be available when the arm is to be filled with fluid: 1. Blood pressure manometer with adult cuff or tourniquet 2. Small receptacle, bowl, cup or similar container 3. ½ litre of distilled water The following items should be available for training: 1. A 2,5 or 10 ml syringe with needle, max. 1.0 mm O.D. (gauge 20) 2. A small amount of distilled or demineralised water for injection 3. Infusion catheter with cannula, max. 1.0 mm O.D. (gauge 20) 4. Set of infusion tubes, possibly with drip chamber 5. Infusion reservoir filled with distilled water

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2. Specifications Length of arm: Weight incl. carry case but excl. accessories: Weight excl. carry case and accessories: Dimensions of carry case: Capacity of reservoir: Height of infusion stand:

68 cm 3.0 kg 1.5 kg L 75 x W 15 x H 11 cm Approx. 260 ml 69 cm

Materials: Parts Skin Arm and hand Veins and artery Indicator and other tubes Storage bag/training underlay Infusion stand

Materials Natural latex PVC, hard Natural latex Silicone rubber Nylon reinforced PVC Stainless steel

Red dye concentrate consists of: 760 ml (0,76 l) sugarfree fruit colouring 116 ml (0,116 l) surface active agent 0,3 ml (0,0003 l) silicone oil 3 ml (0,003 l) preservative 120,7 ml (0,1207l) water

WARNING During transportation by airplane the fluid inside the I.V. Trainer must be drained off. Note: It is very important that only distilled water is used when filling the arm and when simulating infusion and injection, otherwise the tubes simulating veins and arteries become sticky and the material will decompose. During storage between training sessions the I.V. Trainer must be covered or placed in the carrying case. The tubes simulating veins and arteries and the skin are made of natural latex. The arm must therefore not be exposed to sunlight or other U.V. (ultra-violet) rays as the material will become sticky and decompose.

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3. Description

fig. 1

1. Four transparent tubes which indicate change of colour in three veins (two with y-branches) and one artery. 2. Gauge for indicating reservoir fluid level. 3. Filling tube for reservoir. 4. Renewable veins and artery made of self sealing material. 5. Palpable radial artery pulse. 6. Swivel elbow joint, with 180º rotation. 7. Integral fluid reservoir, approx. capacity 260 ml. 8. Integral valve between veins/artery and fluid reservoir to prevent air pockets developing in veins and artery. 9. Flexible wrist. 10. Pulse bellows. 11. Slot for mounting of arm on carry case or on the Ambu Man CPR manikin.

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4. Preparation 4.1 Unpacking When the carry case is opened, the arm is secured to the underlay at the shoulder joint. The carry case functions as a washable and fluidproof underlay during training. The arm can be raised, swung sideways around the retaining device and swivelled (180º) at the elbow joint (fig. 2). Mount the infusion stand in the shoulder fixture (fig. 3).

fig. 2

fig. 3

4.2 Mixing of infusion fluid Mix 5 ml of the red dye concentrate supplied with 260 ml distilled water (ratio approx. 1:50).

4.3 Filling the system Remove the levelling tube from the uppermost tube connector on the shoulder (fig. 4). Attach the overflow tube (the separate overflow tube supplied) to the connector and insert the other end of the tube into a receptacle to prevent spillage during filling (fig. 5).

fig. 4

fig. 5

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Draw fluid into the 50 ml syringe supplied and connect the syringe to the levelling tube (fig. 6). Inject the fluid slowly into the fluid reservoir of the arm. Repeat until fluid emerges from the overflow tube and enters the receptacle (fig. 7). The capacity of the infusion arm is approx. 260 ml.

fig. 6

fig. 7

Remove the overflow tube from the connector (fig. 8). Withdraw approx. 20 ml into the syringe and disconnect the syringe from the levelling tube. This is done to ensure that the fluid reservoir can contain the liquid supplied during training of infusion. Now reconnect the levelling tube to the tube connector (fig. 9).

fig. 8

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fig. 9

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4.4 Air removal from veins and artery Attach a blood pressure cuff to the upper arm and inflate to max. 80 mm Hg (fig. 10), or apply a tourniquet. Insert a needle of max. 1.0 mm O.D. - mounted on a syringe without piston approximately 1 cm from the end into the first branch of the vein on the back of the hand (fig. 11). The tube ends being sealed with silicone rubber and a metal ball, no fluid can escape when the needle is inserted at the very end of the tubes. When fluid starts flowing into the syringe without air bubbles, pull out the needle and empty the syringe. Insert the needle into the next vein until the air is removed from all five vein ends and one artery end.

fig. 10

fig. 11

Correct air removal will be indicated by a colour change on the indicator for the relevant vein/artery (fig. 12). Check cuff pressure during air removal and adjust if required, or, when using a tourniquet, tighten as necessary. Release the pressure from the cuff and remove. If a tourniquet is used, loosen and remove. The arm is now ready for training. Remove the filling tube from the tube connector to check the normal level of the reservoir fluid (fig. 13). As described under Section 4.3 the system can be refilled with coloured fluid or destilled water as required.

fig. 12

fig. 13

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5. Using the Ambu l.V. Trainer The Ambu I.V. Trainer is suitable for training in the following procedures: • Preparation and handling of puncturing equipment. • Venous stasis using blood pressure cuff or tourniquet. • Selection of site for puncture. • Disinfection procedure. • Puncturing and insertion methods. • Verification of correct positioning. • Preparation and start of injection and infusion. • Fixation of catheters and tubes. • Puncturing of radial artery. • Arterial blood sampling. • Handling of equipment for venous blood sampling. To create a “blood pressure” in the arm, attach a blood pressure cuff or a tourniquet in the usual way for venepuncture of patients. Inflate the cuff to approx. 80 mm Hg, or tighten the tourniquet before puncturing the vein. Release the air from the cuff or loosen the tourniquet before commencing infusion. Do not inflate the cuff above 80 mm Hg, since higher pressure may cause “the blood” to spurt violently from the needle during puncture. Do not use needles larger than 1.0 mm O.D. (gauge 20) so as not to wear out veins and skin too quickly. If the needle or cannula is correctly positioned, one of the four transparent indicator tubes on the shoulder joint will change colour during injection or infusion of In order to make the indicator tube turn red again, draw back the transparent liquid until the cannula turns red.

5.1 Pulse-taking The instructor can simulate arterial pulse by pressing the bellows.

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6. Cleaning The latex which simulates the skin can be removed from the arm (fig. 14). To facilitate the removal of the skin, apply talcum powder to the outer surface. Normally, it will only be necessary to pull the skin down to the fingers unless the skin needs to be changed. The skin and arm can be rinsed under running water, and the components can be washed with a soft brush. The arm should be removed from the underlay during this procedure, see Section 7. It is to be expected that fluid may collect between the arm and the skin during injections. This is normal and is not the result of leakage. Remove the foam nylon pad covering the arterial pulse during cleaning (fig. 15). If the skin is dirty, the outside can be washed in a mild detergent and then rinsed in clean water.

fig. 14 fig. 15 When the components are dry, apply talcum powder to the inside of the latex skin to facilitate replacement, and pull onto the arm (fig. 16). Do not apply talcum powder to the foam nylon pad as this will block the needle when inserted into the artery. Check the correct position of veins and artery in the grooves of the arm by feeling the outer surface of the skin. If the veins and artery are not positioned correctly, they can be pushed into place from the outside (fig. 17).

fig. 16

fig. 17 11

It is important that the small plastic strap of the pulse bag remains under the artery tube during assembly of the veins (fig. 18). The groove in the foam nylon pad should be fitted so that the artery tube is placed in the groove.

fig. 18

7. Removing and replacing the arm on its holder on the training underlay

fig. 19

The arm can be released from the carry case/training underlay by pressing the black button on the retaining device and detaching the arm from the hook inside the shoulder (fig. 19). Move the arm in the direction of the arrow. Replace the arm by moving it in the opposite direction so that the hook engages the fort mounted through the shoulder joint.

8. Maintenance When not in use, the l.V. Trainer should be stored in the carry case. Keep the case closed to protect the contents against ultraviolet light. Note: It is very important that only distilled water is used when filling the arm and when simulating infusion and injection, otherwise the tubes simulating veins and arteries become sticky and the material will decompose. During storage between training sessions the I.V. Trainer must be covered or placed in the carrying case. The tubes simulating veins and arteries and the skin are made of natural latex. The arm must therefore not be exposed to sunlight or other U.V. (ultra-violet) rays as the material will become sticky and decompose. Depending on frequency of use, it will be necessary to renew the skin, the three veins and the artery from time to time. 12

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8.1 Renewing the skin Remove the skin as described under Section 6 and as shown in fig. 14. To facilitate the mounting of the new skin, apply talcum to the inside before fitting. Hold on to the skin at the elbow and shake the skin to distribute the talcum. Shake off any excess talcum powder before mounting. The arm should be clean and dry before a new skin is mounted and a small amount of talcum should be applied to the outside. Turn the skin inside out as indicated in fig. 20, and start by pulling the skin onto the fingers. Next, pull the skin up over the arm (fig. 21). Pull the skin as far up the arm as to cover the plastic ring and to bend approx. 5-10 mm into the groove of the elbow joint. See photo and drawing (fig. 34). Make sure that the veins and the artery are placed correctly. Compare instructions under Section 6 and in Fig. 17.

fig. 20

fig. 21

8.2 Renewing the veins and artery Before the vein and artery tubes are disconnected, the system should be drained as much as possible. Disconnect the filling tube from the tube connector at the shoulder (fig. 22). Connect the 50 ml syringe to the tube and draw fluid into the syringe. Repeat several times until the reservoir is completely empty (fig. 23).

fig. 22

fig. 23

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First, remove the skin as described under Section 6. The vein and artery tubes can now be disconnected. Push the fluid reservoir aside and press in the catch while carefully pulling the forearm approx. 3 cm clear of the upper arm (fig 25).

fig. 24 fig. 25 Change only one vein or artery tube at a time by pulling the tube free of the arm (fig. 26). Lift the tube end free of the opening in the hand (fig. 27) and make sure that the sealing ball is removed along with the tube.

fig. 26

fig. 27

8.3 Spillage If some of the coloured fluid is spilled on clothes, rinse the spot immediately with tap water adding sulphonic soap and soak in tap water.

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8.4 Mounting new veins and artery The new tubes are marked with numbers to simplify mounting. Remove the marking strip before mounting. fig. 28 shows the position of the individual tube numbers.

fig. 28

The tube ends which are inserted in the hand are sealed with silicone rubber and a ball. Insert the tube end in the opening in the hand (fig. 29). Press the tube into the groove of the arm and pull it through the opening at the elbow joint so that tube No. 1 (fig. 28) is connected to the tube connector marked No. 1, tube No. 2 to connector No. 2 and so forth (fig. 30). Before connecting the tubes to the tube connectors, cut the tubes approx. 2 cm (3/4 inch) from the holes without stretching them. Apply alcohol to the tubes to ease the mounting.

fig. 29

fig. 30

The numbers shown on the photo (fig. 31) correspond to the numbers indicated on the drawing (fig. 28).

fig. 31 15

After connecting the 3 veins and 1 artery, place the plastic cover ring over the tube connectors (fig. 32). Hold down the catch on the forearm and press the forearm against the upper arm until the catch snaps into the groove on the upper arm (fig. 33). Make sure that the two parts are fastened together and that the forearm can turn in relation to the upper arm.

fig. 32

fig. 33

Fit the skin as described under Section 6, fig. 16 & 17. Pull the skin as far up the arm as to cover the plastic ring and to bend approx. 5-10 mm into the groove at the elbow joint. See photo and drawing (fig. 34).

5 - 10 mm

fig. 34

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9. Accessories and spare parts

1

10 9

6 3

5

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} 1 2 3 4 5 6 7 8 9 10

255 000 517 255 000 501 255 000 502 255 000 503 255 000 519 255 000 704 255 000 004 255 000 702 255 000 703 255 000 701 255 000 504

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Latex skin* Set of vein and artery tubes* Pulse bellows with tube connector Pulse balloon with protective cover Foam nylon pad for pulse balloon Red dye concentrate (50 ml bottle) Carry case/training underlay (not shown) 5 ml syringe for fluid mixture 50 ml syringe for filling of reservoir Bottle of talcum Overflow tube 25 cm

*Should always be stored in a dark and cool place.

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Corporate Head Office & Manufacturer: Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: +45 72 25 20 00 Fax: +45 72 25 20 50 E-mail: [email protected] www.ambu.com

USA Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD 21060 Tel.: +1 410 768 6464 Fax: +1 410 760 3993 www.ambu.com

Italy Ambu S.R.L Via Lombardia, 7 I-20060 Vignate (Mi) Tel.: +39 02 953 60415 Fax: +39 02 953 60477 www.ambu.com

France Ambu S.A.R.L Airspace - 6, Rue Gagarine F-33185 Le Haillan Tel.: +33 5 57 92 31 50 Fax: +33 5 57 92 31 59 www.ambu.com

Spain Firma Ambu S.L. C/ Alcalá 261-265, Edificio 1, 3º Izq 28027 Madrid Tel: +34 91 411 68 30 Fax: +34 91 564 50 82 www.ambu.es

Germany Ambu GmbH In der Hub 5 D-61231 Bad Nauheim Tel.: +49 6032 92500 Fax: +49 800 ambude www.ambu.de

Netherlands Ambu B.V. Edisonstraat 16j 2809 PB Gouda Tel.: +31 0182 573293 Fax: +31 0182 531364 www.ambu.nl

UK Ambu Ltd. 8 Burrel Road St. Ives Cambridgeshire PE27 3LE Tel.: +44 1480 498 403 Fax: +44 1480 498 405 www.ambu.com

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