VascoCare EVOLUTION VSHP23 User manual

EVOLUTION Supine Positioners
Instructions for Use
Supine Foot Positioner Supine Head Positioner
VSHP23
Supine Head Positioner Medium Style 2
VSHP24
Supine Head Positioner Large Style 2
VSFP13
Supine Foot Positioner Medium
Intended Use
These Reusable Patient Positioners are used to protect the bony prominence of a Patient’s body and help reduce the risk
of developing pressure sores while a Patient is resting on the Operating Table or other Support Surface during
Medical/Surgical Procedures and Examinations by providing an ergonomically shaped stable support to hold the Patient
and preventing them from accidentally moving.
Instructions for Use
1. Always read the Instructions for Use before using the positioners. Product only to be used by trained personnel.
2. Wipe product clean with disinfectant before use.
3. Keep Positioner clean and dry before use and always place on a dry support surface before use.
4. Always inspect Positioner before use for any signs of damage. Do not use if damaged.
5. Remove product if it is unsuitable for surgery.
6. Place Pillow/Knee Support under Legs to prevent Hyperextension of Knees when using Supine Foot Positioners.
7. Do not use tilt positions without strapping patient securely on the operating table.
8. Uneven surfaces can lead to strain of the limbs, which could cause patient injury.
9. During operative procedure avoid subjecting products to unusual and exaggerated stresses, as this may have an
adverse effect on a patient.
10. Avoid peak interface pressures to patient’s bony prominences.
11. Ensure the occipital bone is located in the recess of the Head Positioner at all times.
12. Ensure that the patient is positioned in a natural posture before surgery when using the positioners.
13. Move Patient periodically on the Positioners to reduce risk of pressure sore development.
14. Do not use the positioner at the surgical site.
15. Do not place the positioner where these might cause friction and skin injury.
16. Avoid pooling of fluids that may cause the patient’s skin to become irritated.
17. Monitor for moisture or oedema on the patient skin.
18. Avoid conditions of electro static discharge and ignition sources.
19. Dispose of product in compliance with Hospital Waste Disposal Procedure.
20. The positioner is suitable for X-Ray and CT Scan.
21. The product should be stored at room temperature before use.
22. Do not place heavy weights on the positioner while in storage.
23. Use standard Hospital Disinfectants to clean products after use.
24. Do not soak product in disinfectant during cleaning process. Wipe product clean with disinfectant after use.
25. Do not overheat positioner.
26. Avoid contact of product with sharp objects.
27. Dispose of positioner when there is deterioration in the function or damage to the product.
28. Gas sterilization, autoclaving, machine washing and drying are not recommended for this product.
29. Retain a copy of the Instruction for Use on file for future reference.
30. If any questions or doubts arise, contact the VascoCare Medical Team or your local distributor.
31. Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the
Competent Authority of the Member State in which the user is established.
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Unique Device Identifier-Product Identifier (UDI-DI)
VSHP23 Supine Head Positioner Medium Style 2
539153592000E2
VSHP24 Supine Head Positioner Large Style 2
539153592001E4
VSFP13 Supine Foot Positioner Medium
539153592002E6
IFU Code: IFU-VSP-03 Date of Issue: 9th November 2021 Revision: 2
© The information provided is the copyright of VascoCare Medical Limited.
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