Aeonmed VG70(E) UK Unboxing and Setup Instructions Ver 1.0

Purpose of this Document

• To provide supplementary guidance (to that in the official manufacturers documentation) in the unboxing and setup of the VG70(E) • To provide a mechanism for registering VG70(E) products into the UK Support & Warranty cover provided by Ortus Medical *

* Registration of product is required for any manufacturer backed support and warranty claims

VG70(E) UK Packaging

The VG70(E) UK deliveries are packaged in two boxes: Box 1 (Smaller)

2

• VG70(E) ICU Ventilator 1

• VG70(E)Consumables/Accessories box • Dimensions (W x D x H) 81 x 69 x 115cm • Gross Weight 25kg / Net weight 15kg Box 2 (Larger) • VG70(E) Trolley • Dimensions (W x D x H) 64 x 54 x 94cm • Gross Weight 40kg / Net weight 25kg

Packing List / Inspection certificate • Within Box 1 is a Packing list and Inspection Certificate. • Please check off each item delivered from the Packing list when unboxing. • Items 23 and 24 are packaged in Box 2. • For any deliveries with items missing; a copy of the Packing list and Inspection certificate will be required for warranty claims.

Example Inspection Certificate

Example Packing list

Assembly Instructions – Step 1 – Trolley Assembly 1-A

1-B

1-C

1-D

• Unbox and remove packaging from the larger of the two boxes (Box 2) until the trolley as shown in photo 1-A. • The top of the trolley contains the ventilator mounting base plate. Unscrew the black locating screw from its transit position in photo 1-B and re-insert from under the trolley base plate as shown in photo 1-C. • Ensure the threaded screw is flush with the trolley base plate as shown in photo 1-D if this protrudes from the surface of the base plate, the installation of the ventilator is impossible.

Assembly Instructions – Step 2 – Main unit attachment to trolley 2-A

2-B

2-C

2-D

• Unbox and remove the packaging from the smaller of the two boxes (Box 1) and separate into the three parts; Ventilator main unit, ventilator screen and the Accessories / Consumables box as shown in photo 2-A. • Unpack the main ventilator unit and place this on the trolley prepared in Step 1. Align the two locating pins on the base of the ventilator with the locating holes on the trolley base (photo 2-B). • Lower the ventilator main unit onto the trolley base such that its sits level as shown in Photo 2-C. Note that the front and rear of the unit is not flush at this point. • Push the ventilator main unit towards the front of the trolley such that the locating pins are locked in and the unit is flush with the trolley as shown in photo 2-D. Then tighten the black locating screw thread as shown in photo 1-C.

Assembly Instructions – Step 3 – Screen Attachment to Main unit 3-A

3-B

3-C

• Remove the packaging from ventilator screen and place this on top of the main unit as shown in Photo 3-A. • Connect the ventilator screen display cable to the main unit and using a Philips screwdriver secure the cable with the small white cable clamp as shown in photo 3-B. • Locate the ventilator screen into the V shaped mounting slot on the main unit such that the screen stands in its operating position as show in photo 3-C.

Assembly Instructions – Step 4 – Battery Installation 4-A

4-B

4-C

4-D

• Rotate the ventilator on its cart around, such that the rear of the main unit can be accessed and remove the 4 Philips screws holding the battery cover in place (photo 4-A). • Locate the Battery from the accessories / consumables box, it is packaged in a paperback sized brown box, remove the battery ready for installation (photo 4-B). • The Battery can then be inserted into either of the two slots, the photo 4-C shows the battery in the left-hand slot, but this can be inserted in the right or an additional battery can be installed (not supplied). Once installed the cover can be re-attached with the screws. • Once power is applied to the device (latter steps), the battery charging icon and battery status will appear on the front of the screen (photo 4-D).

Assembly Instructions – Step 5 – Hospital Oxygen Connection 5-A

5-B

5-C

5-D

• Locate the Oxygen Inlet filter from the accessories / consumables box; this is contained in a plastic bag which should be removed (photo 5-A). • Install the Oxygen Inlet filter at the rear of the Ventilator main unit, tightening the threaded connector until hand tight against the oxygen inlet ensuring it is orientated as in photo 5-B. • Locate the Oxygen supply connection hose from the accessories / consumables box; this is supplied coiled with tie wraps that should be removed (photo 5-C). • The Oxygen supply connection hose can now be connected to the Ventilator and then connected to the local oxygen source as shown in photo 5-D.

Assembly Instructions – Step 6 – Power Supply Connection 6-A

6-B

6-C

6-D

• Locate the Two black power cords (1 x UK Mains Plug to IEC female connector and 1 x IEC female to IEC male connector) from within the accessories / consumables box and remove the cable ties (photo 6-A). • Connect the UK Mains Plug to IEC female connector to the bottom IEC male connection socket on the trolley side and the IEC female to IEC male connector to the top IEC female socket as shown in photo 6-B. • Connect the other end of the IEC male connector to the main ventilator module and using a Philips screwdriver secure the cable with the small white cable clamp as shown in photo 6-C. • The Unit can then be connected to the UK mains supply and powered on at the wall and on the back of the main unit behind the clear protective cover (photo 6-D).

Assembly Instructions – Step 7 – Setup of Arm for Patient Circuits 7-A

7-B

7-C

7-D

• Included in the accessories / consumables box is a Patient circuit support arm (large brown box) packaged as shown in photo 7-A, and a small black house mounting bracket also shown in photo 7-A. • Unpack the Arm from its box and connect the Arm screw thread to the base plate of the Ventilator trolley as shown photo 7-B. • Remove the plastic packaging from the black hose support bracket and install into the Arm as shown in photo 7-C. • The fully assembled Arm and hose support bracket should now look like photo 7-D.

Assembly Instructions – Step 8 – Setup of included Humidifier 8-A

8-B

8-C

8-D

• The VG70(E) is supplied with a Humidifier to ensure that it can be used out of the box to treat patients (the supplied configuration should be reviewed by local operators as it may lack features depending on intended use). • The Humidifier included with the ventilator is supplied in the accessories / consumables box as shown on photos 8-A / 8-B. It can be powered from the trolley using its supplied power cord. Note for alternate Humidifiers power supply connections may differ. • To connect the Humidifier to the Trolley power, remove the metal cover mounting screws with a Philips screwdriver and install the power connector, then replace the cover as indicated in photo 8-C. • The humidifier can now be mounted on the trolley as shown in photo 8-D.

Assembly Instructions – Step 9 – Setup of included Patient Circuit 9-A

9-B

9-C

9-D

• The VG70(E) is supplied with a Reusable Patient circuit to ensure that it can be used out of the box to treat patients (the supplied configuration should be reviewed by local operators prior to us as it may not meet their requirements). • The Patient Circuit, Test lung and CPAP Mask included with the ventilator is supplied in the accessories / consumables box and are shown packaged in photos 9-A / 9-B / 9-C. • The circuit consists of 5 legs and 2 water traps (photo 9-D). Should the user decide to operate the machine without the humidifier, the double water trap circuit (4 Legs) can be connected directly to the ventilator.

Annex A – Typical VG70(E) Accessory / Consumables box contents – Key components 1 2

4 5

3

8 6

7

12 11 9

10

1. Humidifier 2. Arm for Patient circuit 3. Humidifier Chamber 4. Test Lung 5. Patient Hose Circuit 6. IEC female to IEC male connector 7. UK Mains Plug to IEC female connector 8. Circuit hose support bracket 9. Battery 10. Oxygen Inlet filter 11. Oxygen supply connection hose 12. CPAP Mask

Annex B – Typical VG70(E) Accessory / Consumables box contents – Spares/Additional Items

1

3

2

4

7 5

8

9

6 13 10

11

12

14

1. 2 x Spare Breathing Bacterial Filters 2. Nebulizer set with tubing 3. Airway connector 4. Air Inlet Filter element 5. User Manual 6. Circuit hose support bracket (small) 7. Airway connector – right angle 8. 2 x Spare Fuse 3.15A / 250V 9. Oxygen Inlet sintered filter 10. Spare cotton fan filter 11. Spare water trap 12. 2 x spare expiratory valve seal 13. Expiratory value one-way diaphragm 14. Expiratory valve seal removal tool

Annex C - Product Acceptance Test Log Completion

Once assembled in order to register the product please complete the VG70 Acceptance log and email a copy to [email protected] within 30 days The VG70 Acceptance log (example left) can be downloaded here: http://www.theortusgroup.com/vg70/ The warranty provided with the VG70 is in line with the NHS Supply chain terms and conditions. • Main Ventilator – 1 Year. • Accessory Parts and Spares – 3 Months. • All consumable and wear and tear parts are excluded from the warranty.