Mölnlycke
Molnlycke Z Flex Heel Boot | Advanced Heel Offloading Boot for Pressure Ulcer Prevention
Molnlycke Z Flex Heel Boot | Advanced Heel Offloading Boot for Pressure Ulcer Prevention
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The Mölnlycke Z Flex Heel Boot delivers total heel suspension via a proven foam-bridge design, eliminating calcaneal interface pressure regardless of patient position changes. Its Z-shaped foam geometry redistributes leg weight along the calf and lower leg, producing zero-pressure at the heel without rigid plastic components that restrict blood flow or cause secondary pressure points.
Technical Specifications
| Parameter | Specification |
|---|---|
| Offloading Mechanism | Total heel suspension (zero calcaneal interface pressure) |
| Construction | Multi-density polyurethane foam, Z-bridge geometry |
| Lining | Breathable cotton-blend moisture-wicking inner |
| Closure System | Adjustable hook-and-loop (Velcro) straps × 3 |
| Oedema Accommodation | Adjustable up to +6 cm limb circumference variation |
| Indications | Heel PI prevention (Category I–IV), post-surgical heel protection, diabetic foot offloading, immobile/sedated patients |
| Clinical Setting | ICU, surgical wards, rehabilitation, long-term care, home care |
| Latex Content | Latex-free |
| Biocompatibility | ISO 10993 tested |
| Quality Management | ISO 13485:2016 |
| Singapore Registration | HSA-registered Class A medical device |
| Manufacturer | Mölnlycke Health Care AB, Sweden |
Clinical Q&A
Q: Why is heel pressure injury prevention clinically critical in ICU and post-operative patients?
A: The heel is the second most common site for pressure injuries (after the sacrum), accounting for approximately 30% of all hospital-acquired pressure injuries (HAPIs). ICU and post-surgical patients are particularly vulnerable due to: immobility, peripheral oedema reducing perfusion, vasopressor medications causing peripheral vasoconstriction, and the prominent calcaneus creating a small, high-load contact area. The EPUAP/NPIAP/PPPIA 2019 Guideline specifically mandates heel offloading as a standard intervention for at-risk patients.
Q: How does the Z Flex achieve zero heel pressure while maintaining limb stability?
A: The Z-bridge polyurethane foam construction distributes the weight of the lower leg across the calf and mid-leg contact surfaces, elevating the heel completely off the mattress. Unlike rigid plastic heel cups that merely redistribute load, the foam suspension eliminates interface pressure entirely. Three-point strap closure maintains foot position and prevents foot-drop without constricting the Achilles tendon or malleoli.
Q: Is the Z Flex Boot compatible with compression bandaging and anti-embolism stockings?
A: Yes. The adjustable hook-and-loop closure system accommodates limb circumference increases of up to +6 cm, making it compatible with the underlying application of Class I–II compression hosiery or graduated compression bandaging systems. Anti-embolism stockings can be worn beneath the boot without modification.
Q: How frequently should the Z Flex Heel Boot be inspected during clinical use?
A: Per EPUAP/NPIAP/PPPIA guidelines, heel offloading device checks should be performed at every patient repositioning cycle (minimum every 2 hours in acute settings) to confirm: (1) heel suspension is maintained; (2) straps are not constricting; (3) perimalleolar and Achilles areas show no secondary pressure. The boot should be removed at least twice daily for skin inspection and limb assessment.
Q: What regulatory standards apply to the Mölnlycke Z Flex Heel Boot?
A: The Z Flex is manufactured under ISO 13485:2016 quality management at Mölnlycke facilities and has passed ISO 10993 biocompatibility evaluation (cytotoxicity, skin sensitisation). It is registered with Singapore's Health Sciences Authority (HSA) as a Class A medical device, consistent with its low-risk orthopaedic/positioning classification under the Health Products Act.
Regulatory & Standards References
- ISO 13485:2016 — Medical devices quality management; Mölnlycke manufacturing certification
- ISO 10993 — Biological evaluation; biocompatibility of foam and textile materials confirmed
- HSA Singapore — Class A medical device registration; Health Products Act orthotic/positioning classification
- EPUAP/NPIAP/PPPIA 2019 — International Pressure Injury Prevention and Treatment Guidelines; recommends heel offloading devices for all at-risk patients
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