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1 Designed by: Independently tested by:

12 Pretty Legs Hosiery Limited Caldow House, Crescent Road Lutterworth Leicestershire LE17 4PE Tel: 01455 206920 Fax: 01455 553772 The

2 Contents Introduction 3 How they work. 3 How they are made. 4 Product Ranges and Sizes. 5 Saphena Medical. 5 Sizing. 6 Sizing (in detail). 7 Saphena Grip. 8 Saphena Plus. 9 Saphena White. 10 Ordering Details. 11 Declaration of Conformity. 12 Pretty Legs Hosiery Limited Caldow House, Crescent Road Lutterworth Leicestershire LE17 4PE Tel: Fax: The Quality Management System of Pretty Legs Hosiery has been approved by Lloyd s Register Quality Assurance to QMS Standards ISO Pretty Legs Hosiery Limited 2

3 Saphena AES Introduction The purpose of anti-embolism stockings is to reduce a person's risk of developing venous thromboembolism, or VTE. Deep vein thrombosis occurs when a blood clot forms in one of the deep veins of the body. Anti-embolism stockings are compression stockings that are often worn following major surgery or an acute illness that results in reduced mobility. Someone with a high risk for VTE may be instructed to wear anti-embolism stockings even if they are released from the hospital shortly after surgery. Anti-embolism stockings are typically worn during the day and while the patient is sleeping, but they may be removed for showering or bathing. Saphena Anti-Embolism Stockings were designed by Mr Stephen Barker (Senior Lecturer in Surgery, Consultant General & Vascular Surgeon) and Dr Simon Hollingsworth (Lecturer in Molecular Medicine) in 2002/2003. The extensive knowledge and experience of the Pretty Legs development team in manufacturing high quality hosiery was used to bring the design to fruition. Saphena was trialled within University College London Hospitals NHS Trust (according to trial guidelines laid down for NHS Trust hospitals by the NHS's Healthcare Purchasing Consortium, and as submitted to the venous surgery journal Phlebology). The trial within the hospital setting gave patient scores of > 95% to; comfort, ease of use and quality. Senior nursing staff had a direct input in to the final design of the product. Saphena has the endorsement of University College London, the first product in 175 years to achieve this. Saphena is a Class I medical device and conforms to the latest European Standards for graduated compression and also complies with the Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993.) The compression profile of 18mmHg (ankle), 14mmHg (calf) and 8mmHg (upper thigh) is in line with British Standard 7672:1993 (Specification for compression stiffness and labelling of antiembolism hosiery) as specified by NICE Clinical Guideline: CG92 (Venous thromboembolism; reducing the risk for patients in hospital), it is independently tested at regular intervals by The Surgical Materials Testing Laboratory - SMTL which is part of the Welsh NHS and based at the Princess of Wales Hospital in Bridgend. Test certificates from SMTL are available upon request. How they work Saphena anti-embolism stockings provide pressure to force blood back towards the heart with graduated compression which is strongest at the ankle and reduces further up the leg. By compressing the surface veins, arteries and muscles, they force circulating blood through narrower channels. As a result, the arterial pressure is increased, which causes more blood to return to the heart and less blood to pool in the feet 3

How they are made Saphena AES are a unisex product manufactured exclusively in the UK by Pretty Legs Hosiery Limited under the Pretty Legs Health division at their factory in

The stockings are manufactured in a controlled and air conditioned area of the knitting plant and tested to British Standard 7672:1993 during and after production.

The exact combination which is tailored throughout the length of the stocking from the ankle upwards, together with the temperature of the dying process, sets the compression of the

The development team at Pretty Legs have continued to develop the stockings over the years with changes to the non-compression areas such as heel placement, adding a grip sole

4 How they are made Saphena AES are a unisex product manufactured exclusively in the UK by Pretty Legs Hosiery Limited under the Pretty Legs Health division at their factory in Lutterworth, Leicestershire. The stockings are manufactured in a controlled and air conditioned area of the knitting plant and tested to British Standard 7672:1993 during and after production. Knitting design showing bi-stretch detail. A combination of nylon and specialised elastomeric yarns are knitted together to form a two way or bi-stretch material. The exact combination which is tailored throughout the length of the stocking from the ankle upwards, together with the temperature of the dying process, sets the compression of the garment. The development team at Pretty Legs have continued to develop the stockings over the years with changes to the non-compression areas such as heel placement, adding a grip sole variation and adjusting the makeup of the stocking tops for the added comfort and correct use by patients and nurses, with the latest amendment being in March Testing is performed in the environment controlled, air conditioned lab by experienced personnel with a thorough knowledge of the British Standard. The Hatra brand testing devices are calibrated on a daily basis. They are the same devices specified in the British Standard and identical to the devices used by SMTL, the external testing lab in Bridgend which is part of the Welsh NHS. 4

5 Product Ranges and Sizing Saphena AES are produced in two basic types: Below Knee and Thigh Length, each has a grip sole variant to help reduce the risk of trips and falls. Saphena Medical 5

Sizing The stockings are colour coded by size for easy Identification. Below Knee comes in five sizes: Small, Standard, Large, X-Large and Plus (bariatric). Reduces inventory stock cost savings.

Reduces nursing time when measuring patients. Thigh Length comes in four sizes: Small, Standard, Large and X-Large.

6 Sizing The stockings are colour coded by size for easy Identification. Below Knee comes in five sizes: Small, Standard, Large, X-Large and Plus (bariatric). Reduces inventory stock cost savings. Colour coded packaging and stockings reduces nursing time in identifying correct size. Single ankle measurement Tape measure is colour coded to correspond with range. Reduces nursing time when measuring patients. Thigh Length comes in four sizes: Small, Standard, Large and X-Large. Colour coded packaging and stockings reduces nursing time in identifying correct size. Reduces inventory stock cost savings. Ankle and upper thigh measurement Reduces nursing time when measuring patients. Tape measure is colour coded to correspond with range. A ward sizing chart is provided to assist nurses in fitting the correct size of stocking to the patient. 6

7 Sizing (in detail) Saphena AES have been developed using information gained from extensive measurement of a typical in-hospital patient population in conjunction with Pretty Legs vast experience in sizing highstreet hosiery (tights, stockings and socks). Using measurements of ankle circumference, calf circumference, length of foot, length of leg and age, models were created to generate an understanding of individuals variability. From this, and utilizing manufacturing expertise, a series of sizes have been generated to provide the correct compression within a size range and which enables the majority of the population to be accommodated whilst providing the compression detailed in BS Also, due to the way in which the stocking sizes have been generated, most individuals can be accommodated by either of two sizes whilst still maintaining the correct appropriate compression. As such, if the smaller of two sizes seems to the patient to be a little uncomfortable, then the next largest size can be utilized to aid comfort whilst still maintaining the compression required. The stockings are provided with information indicating the compression provided with increasing ankle circumference. This allows comparison of the compression provided by size, and helps to aid choice of size to facilitate patient comfort. Saphena stockings only require a single measurement at the ankle. Compression is provided at the ankle, graduating with position upwards to the knee; BS 7672 requires the compression at the ankle to graduate to 80% at the calf. The determining factor in providing compression is the volume of the leg between the ankle and the knee - determined by the limb dimensions such as ankle to knee length, circumference of the calf, etc. The sizing of the stockings allows for a reasonable variation in limb volume, if appropriate compression is provided at the ankle (~18mmHg), an appropriate compression will be provided up the calf towards the knee (graduating to 80%; ~14mmHg). Other brands may have compression at the ankle less than 18mmHg (but which still falls within manufacturing tolerance) and so accordingly, these may feel less tight than Saphena stockings, and may be more easy to don. Greater compression is better (unless contra-indicated). To aid donning of the stockings and to facilitate a more comfortable fit and feel for the patient, Saphena stockings are manufactured without compression in the foot. There can be exceptions to the 80% graduation upwards from the ankle, but mainly in extreme cases, such as; Thin ankles relative to calf size Thick ankles relative to calf size Slim ankles relative to calf size - a more common observation In these cases, if appropriate compression is provided at the ankle, there may be greater compression at the calf - the patient may say that the stockings feel tight. For most cases, this should not be a problem as greater compression up the calf will aid the beneficial effects of compression hosiery, i.e. improve venous return and reduce swelling. Also, the manufacture of the stockings allows a good degree of variation, compression can be maintained within the guidelines of BS 7672, and (as above), individuals can consult the sizing chart provided to decide on the use of the next larger size. Thick ankles relative to calf size - a less common observation In these cases, if appropriate compression is provided at the ankle, there may be lesser compression at the calf. For most cases, this should not be a problem as the manufacture of the stockings allows a good degree of variation, and compression can be maintained within the guidelines of BS In extreme cases, individuals can consult the sizing chart provided to decide on use of the next smaller size. 7

Saphena Grip In addition to Saphena AES, Saphena Grip AES is an innovative range of anti-embolism stockings designed to reduce slips, trips and

Working with experienced Nurse Specialists within the NHS, an effective grip sole was developed which is applied to create a complementary range

$The cost of a fall can vary greatly depending on severity, but can cost as much as 4,603 for a single fractured hip.$ $Moderate to severe incidents (excluding fractures and head injuries) are estimated to cost a trust between 324 to 446 per fall and even no harm$

8 Saphena Grip In addition to Saphena AES, Saphena Grip AES is an innovative range of anti-embolism stockings designed to reduce slips, trips and falls in hospital. Working with experienced Nurse Specialists within the NHS, an effective grip sole was developed which is applied to create a complementary range of anti-embolism stockings. Saphena Grip assists hospitals in managing the number of trips and falls as well as reducing the risk of DVT. Patient falls cost the NHS an estimated 2.3 billion a year. NICE guidelines CG161 (Falls in older people: assessing risk and prevention). The cost of a fall can vary greatly depending on severity, but can cost as much as 4,603 for a single fractured hip. Moderate to severe incidents (excluding fractures and head injuries) are estimated to cost a trust between 324 to 446 per fall and even no harm incidents are estimated to cost 41 per fall (Slips, trips and falls in hospital report - Patient Safety Observatory, NPSA 2007). With Saphena Grip, at risk patients benefit from the proven DVT protection of the leading antiembolism stocking, as well as the confidence of having a grip sole to reduce the risk of falling. 8

Saphena Plus (Bariatric) Saphena Plus, is the anti-embolism stocking developed in response to requests from several NHS Trusts for a larger size stocking for bariatric patients and for some

We also offer Plus Grip anti-embolism stockings which are fitted with a grip sole to help prevent slips, trips and falls.

9 Saphena Plus (Bariatric) Saphena Plus, is the anti-embolism stocking developed in response to requests from several NHS Trusts for a larger size stocking for bariatric patients and for some maternity patients. Our Plus antiembolism stockings are available in the Below Knee range. We also offer Plus Grip anti-embolism stockings which are fitted with a grip sole to help prevent slips, trips and falls. In accordance with NICE clinical guideline CG92 (Venous thromboembolism; reducing the risk for patients in hospital) our Plus and Plus Grip anti-embolism stockings conform to the same parameters as listed in independent testing from SMTL (Surgical Materials Testing Laboratory). Please note: The Plus and Plus Grip stockings are not suitable for patients with a calf size exceeding 65cms. 9

Saphena White Saphena White is manufactured using exactly the same compression specification and processes as our market leading Saphena Medical - Saphena Grip ranges but has the more

10 Saphena White Saphena White is manufactured using exactly the same compression specification and processes as our market leading Saphena Medical - Saphena Grip ranges but has the more traditional white colour that some healthcare organisations and their staff are familiar with as AES products. It has the same easy to identify colour sizing scheme common to all our AES ranges. 10

11 Ordering Details Saphena Medical Anti-Embolism Stockings Ankle Measurement Size Below Knee Thigh Length Maximum Thigh Circumference cm Small SMBKSML SMTLSML 65 cm cm Standard SMBKSTD SMTLSTD 70 cm cm Large SMBKLGE SMTLLGE 78 cm cm Extra Large SMBKXLG SMTLXLG 82 cm cm Plus (xx large) SBBKXX - - Saphena Grip Anti-Embolism Stockings Ankle Measurement Size Below Knee Thigh Length Maximum Thigh Circumference cm Small SGBKSML SGTLSML 65 cm cm Standard SGBKSTD SGTLSTD 70 cm cm Large SGBKLGE SGTLLGE 78 cm cm Extra Large SGBKXLG SGTLXLG 82 cm cm Plus (xx large) GSBBKXX - - Saphena White Anti-Embolism Stockings Ankle Measurement Size Below Knee Thigh Length Maximum Thigh Circumference cm Small SWBKSML SWTLSML 65 cm cm Standard SWBKSTD SWTLSTD 70 cm cm Large SWBKLGE SWTLLGE 78 cm cm Extra Large SWBKXLG SWTLXLG 82 cm 11

12 EC Declaration of Conformity Declaration Number: DC Manufacturer: Pretty Legs Hosiery Limited Caldow House Crescent Road Lutterworth Leicestershire LE17 4PE UK Product Family Name: Medical Compression Hosiery Product Sizes/Codes: See Attached Schedule Classification (MDD, Annex IX) and Rule Number: Class I, Annex VII, Rule Number 1 Declaration Pretty Legs Hosiery Limited hereby declares that the device specified above conforms with the Essential Requirements of the Medical Device Directive - 93/42/EEC of June 14, 1993 as amended by Directive 2007/47/EC of 21st September The stated products are designed and manufactured by Pretty Legs Hosiery Limited, in accordance with the scope of a quality system which meets the requirements of ISO 9001:2008 and the Medical Devices Directive - 93/42/EEC To ensure conformity with the provisions of the Directive applicable to Class I medical devices, Pretty Legs Hosiery Limited has designed and manufactured the device specified within the product schedule in accordance with: - BS 7672: 1993 Specification for compression, stiffness and labelling of anti-embolism hosiery - ISO 9001:2008 Quality management systems. Requirements Authorised by: Scott Barker Director 21 st October

13 Product Schedule Product Sizes/Codes: Description Model Type Product Code Saphena Medical Below Knee Anti-Embolism Sock Small SMBKSML Saphena Medical Below Knee Anti-Embolism Sock Medium SMBKSTD Saphena Medical Below Knee Anti-Embolism Sock Large SMBKLGE Saphena Medical Below Knee Anti-Embolism Sock Extra Large SMBKXLG Saphena Medical Thigh Length Anti-Embolism Sock Small SMTLSML Saphena Medical Thigh Length Anti-Embolism Sock Medium SMTLSTD Saphena Medical Thigh Length Anti-Embolism Sock Large SMTLLGE Saphena Medical Thigh Length Anti-Embolism Sock Extra Large SMTLXLG Saphena Grip Below Knee Anti-Embolism Sock Small SGBKSML Saphena Grip Below Knee Anti-Embolism Sock Medium SGBKSTD Saphena Grip Below Knee Anti-Embolism Sock Large SGBKLGE Saphena Grip Below Knee Anti-Embolism Sock Extra Large SGBKXLG Saphena Grip Thigh Length Anti-Embolism Sock Small SGTLSML Saphena Grip Thigh Length Anti-Embolism Sock Medium SGTLSTD Saphena Grip Thigh Length Anti-Embolism Sock Large SGTLLGE Saphena Grip Thigh Length Anti-Embolism Sock Extra Large SGTLXLG Saphena White Below Knee Anti-Embolism Sock Small SWBKSML Saphena White Below Knee Anti-Embolism Sock Medium SWBKSTD Saphena White Below Knee Anti-Embolism Sock Large SWBKLGE Saphena White Below Knee Anti-Embolism Sock Extra Large SWBKXLG Saphena White Thigh Length Anti-Embolism Sock Small SWTLSML Saphena White Thigh Length Anti-Embolism Sock Medium SWTLSTD Saphena White Thigh Length Anti-Embolism Sock Large SWTLLGE Saphena White Thigh Length Anti-Embolism Sock Extra Large SWTLXLG Saphena Below Knee Plus Size Anti-Embolism Sock Extra Extra Large SBBKXX Saphena Below Knee Grip Plus Size Anti-Embolism Sock Extra Extra Large GSBBKXX 13

14 CERTIFICATE OF APPROVAL This is to certify that the Quality Management System of: Pretty Legs Hosiery Crescent Road, Lutterworth, Leicestershire United Kingdom has been approved by Lloyd's Register Quality Assurance to the following Quality Management System Standards: ISO 13485:2003 The Quality Management System is applicable to: Design, manufacturing and distribution of medical hosiery This certificate forms part of the approval identified by certificate number LRQ Approval Original Approval: 26 October 2016 Certificate No: LRQ Current Certificate: 26 October 2016 Certificate Expiry: 31 March 2019 Issued by: Lloyd's Register Quality Assurance Limited 1 Trinity Park, Bickenhill Lane, Birmingham, B37 7ES, United Kingdom Lloyd s Register Group Limited, its affiliates and subsidiaries, including Lloyd s Register Quality Assurance Limited (LRQA), and their respective officers, employees or agents are, individually and collectively, referred to in this clause as Lloyd s Register. Lloyd s Register assumes no responsibility and shall not be liable to any person for any loss, damage or expense caused by reliance on the information or advice in this document or howsoever provided, unless that person has signed a contract with the relevant Lloyd s Register entity for the provision of this information or advice and in that case any responsibility or liability is exclusively on the terms and conditions set out in that contract.

Understanding compression stockings (hosiery) Leg Ulcer Management Team Patient Information Leaflet

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