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6 GENERAL PURPOSE CRYOFREEZERS FROM GENESIS MEDICAL LTD Wallach is the world s leading manufacturer of Cryofreezers and offers sophisticated Multi-tip instruments for power control of freezing using Nitrous Oxide. For some purposes liquid Nitrogen sprayed directly onto the tissue is sufficient and the Wallach Ultrafreeze offers an ergometrically designed delivery system. The Wallach LL100 & LLCO2 Multi-Tip Cryofreezers are simply the best and feature: An instant defrost trigger The fastest most powerful freeze with total control Light well balanced handle Flexible gas hose exits handle for comfort and visibility The Wallach Ultrafreeze Liquid Nitrogen Spray is now available in two sizes, 300ml and 500ml capacity. For more procedures the controlled freezing provided by the LL100 is more effective than liquid nitrogen sprays. For warts only controlled freezing will guarantee destruction of extended roots. Liquid Nitrogen is good for surface lesions over wider areas. It is less efficient than using nitrous oxide or carbon dioxide though a Wallach LL100. Running costs are lower for the LL100 than liquid nitrogen sprays. Genesis Medical offers an unconditional 12 month warranty on Wallach instruments which may be extended by annual contract. Servicing is carried out by Genesis in London workshop. Hundreds of satisfied users attest to the quality of Wallach Cryosurgical products and Genesis service and support. For prices refer to the second last sheet in the binder.

7 GENERAL ADVANTAGES OF CRYOSURGERY Cryosurgery offers specific advantages relating to each of the many fields of application: SIMPLICITY * Non-invasive * Minimal trauma * No Bleeding * No permanent destruction of healthy tissue healthy tissue regrows. * Many procedures normally requiring hospitalisation can be done on an out-patient basis with Cryosurgery * General anaesthetic not usually required * Ideal for out-patients clinic or doctor s office * Less chance of complication for high risk patients ECONOMICAL * No hospitalisation * Less nursing care * No operating theatre time * Often more effective with lower incidence of repeat procedures BENEFITS TO PATIENTS * No general anaesthetic * Less risk of complications non invasive no bleeding * Home the same day * Faster recovery * Less risk of scaring

8 CRYOSURGERY: SCIENTIFIC BASIS AND CLINICAL APPLICATION This section is closely based on a paper bearing the above title that appeared in The Practitioner, April 1973 by Harold MB FRCS, now senior ENT Surgeon, Charing Cross Hospital and Stewart Saunders MB FRCS, later Consultant ENT surgeon, St Georges Hospital, London. Three phrases of Cell Injury Immediate Phase There are four main causes of instant destruction and they may all co-exist. i. Rupture of cell membrane caused by ice crystals in the cell this is most effective if freezing is rapid i.e. greater than 5 C per sec. the most effective destruction is with rapid freezing and slower thawing. ii. iii. iv. Intracellular dehydration with raised electrolyte concentration. The formation of ice crystals during freezing results in dehydration and a resulting toxic concentration of electrolyte. Protein denaturalization. The lipoprotein of the cell membrane, the nucleus and mitochondria are particularly vulnerable to denaturation. Cellular hypometabolism. This causes enzyme inhibition resulting in cell poisoning. Delayed Phase This occurs in a few hours and is due to loss of blood supply caused by destruction of the microcirculation. Late Phase Cryosurgery results in a rise in the level of antibodies against tumors and they may play a part in destroying the tissue. The exact affect of these antibodies is however still debatable.

9 FACTORS AFFECTING CRYOSURGERY The size of the cryolesion is affected by: Probe temperature the lower the temperature the greater the depth of freeze may be, if the flow of gas is high and the time of freeze is sufficient. The freeze provided by N2O gas is colder by about C than that provided by CO2. Most hospitals use N2O rather than CO2. Size of probe tip the greater the area touching the tissue the greater the volume of tissue is frozen. Duration of freeze the freeze radiates in a hemisphere from the tip. The tissue in contact with the tip is coldest and the further out the less cold the tissue is. After a time the freezing will not increase the size of the ice ball because the outer edge is warmed to prevent further freezing and there is then a balance. Freeze/Thaw cycle- after tissue has been frozen, intracellular fluid is released and thermal conductivity is thereby improved. The next freeze after a thaw will then travel faster through the damaged tissue and the iceball and outer perimeter will extend further. Both the freeze and thaw processes cause necrosis. Three freeze/thaw cycles are recommended. Tissue temperature- the body temperature and vascularity affect the speed and extent of freezing. Less vascular tissue thaws more slowly and this causes more necrosis as the ice crystal size and shape varies more than in the case of a rapid thaw in more vascular tissue. ADVANTAGES OF CRYOSURGERY It is simple and safe The growth of the ice ball can be watched- the depth from the tip is the same distance of the observed frozen tissue radiating from the tip. Adjacent large neurovascular structures are safe. This is because collagen and elastic tissue resist freezing and the supporting structure is not destroyed. Destruction of a lesion is certain with aggressive freezing and healing will always follow.

10 Anaesthetic The sensory nerve endings are extremely susceptible to cold so that painful growths are rendered insensitive. Cryosurgery is not very painful and usually local anesthetics are unnecessary. To ensure least discomfort, gently pull back to release pressure on the tissue after the probe is frozen in place. Size The destruction radiates from the probe tip. It is not limited to the site of probe contact as in diathermy. Avascularity There is little or no bleeding during or after treatment. Cryosurgery can be used as an ancillary to ordinary surgery to control bleeding. Asepsis The area of cryonecrosis is of inert quality. A sharp zone demarcation forms with the surrounding tissue, with minimal inflammatory response. When a slough (dead tissue) separates a few days after therapy, a clean granulating base is exposed which repairs rapidly, leaving little or no scaring. IMPORTANT NOTICE ON EXPOSURE TO NITROUS OXIDE The Health and Safety Commission has set occupational standards for anaesthetic gauges including Nitrous Oxide. The Limit for Nitrous Oxide over and 8 hour time- weighted average is 110ppm or 180mg per cubic meter. It is virtually impossible for exposure towards anything close to these limits in a clinical setting.

11 WHICH CRYOGENIC GAS IS BEST FOR YOU? As the World s leader in cryofreezing, Wallach is unique in supplying Cryofreezers for operation with Nitrous Oxide, Carbon Dioxide, and Nitrogen. However, we recommend the Wallach LL100 for Nitrous Oxide. There is a Carbon Dioxide model, the Wallach LLCO2. Your Options: Nitrous Oxide freezes the Wallach LL00 tip to about -89 C. Carbon Dioxide freezes the Wallach LLCO2 tip to about -78 C. Liquid Nitrogen sprays touch the tissue at about -160 C. APPLICATIONS: Nitrous Oxide is ideally suited to applications where a controlled freeze is needed. Instruments using these gasses freeze a metal which generates an iceball on the tissue. The frozen surface as well as the size and shape of frozen tissue beneath is easily judged. Liquid Nitrogen is normally used as a spray and so is most useful where a larger surface freeze is indicated. It is not possible to judge the depth of freeze when using a liquid Nitrogen spray. Frost is quite an effective insulator against heat transference. As soon as liquid nitrogen touches the tissue frost is formed and this insulation prevents the freeze extending more than 1-2 mm maximum. Nitrous Oxide works best where depth and control of freeze is needed such as for Verrucae, Periungal and Plantar Warts, Condyloma, Cervical lesions, Ophthalimics, Otorhinolaryngology, and Proctology. Wallach supplies the popular Ultrafreeze Liquid Nitrigen Spray which is ideal for these applications Liquid Nitrogen is adequate for keratoses, lentigines, hemangiomas and may be more convenient where large areas with shallow depth are treated. Apart from the difference in application, liquid nitrogen is less convenient and more expensive than the other gases.

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20 SERVICE and REPAIR CONTRACT TERMS FOR WALLACH LL CRYOSYSTEMS JANUARY 2018 SERVICE TERMS Cover: Instruments returned for service will be tested as regards efficiency of freeze, ensuring that the temperature drops to a level low enough to be effective; efficiency of the defrost; and a leak test. Minor adjustments are included in the price. Price: VAT includes reunr carriage (but not carriage to Genesis Medical Ltd). REPAIR CONTRACT TERMS Conditions: A Repair Contract is provided to cover instruments from the day an official order is received. Repair Contracts may be ordered only for instruments that are in good working order. Instruments in disrepair should be sent in for repair and the appropriate charge will be made. Repairs are guaranteed for 6 months after which time a Repair Contract may be opened. Repair Contracts do not cover damage caused by improper treatment. Cover: The Repair Contract covers the cost of labour, parts, an annual service and return carriage. Repairs cannot be performed in the hospital and the cost of carriage to Genesis is not covered. Existing contracts may be renewed within 90 days of expiry with no increase in price. Age of Instrument Prices for Repair contracts 0-12 months Full Warranty applies months 12 months repair contract VAT months VAT months VAT months VAT months VAT 72 + months VAT These rates may be adjusted from time to time except that existing contracts will be renewed at no extra cost. Terms : 1. The agreement covers all necessary repairs through normal wear & tear but excludes accidental, wilful or malicious damage 2. The charges include the cost of carriage back to the customer. All repairs are carried out in our workshop. 3. The agreement does not cover any accessories supplied with the instrument (i.e. tips) 4. Genesis reserves the right to vary renewal terms and to refuse to renew an agreement for any instrument or instruments without giving a reason. 5. Genesis reserves the right to inspect any instrument before accepting it into the scheme. Only properly functioning instruments will be accepted.

21 GENERAL PURPOSE CRYOSURGICAL PRODUCTS JANUARY 2018 Price List Equipment Price FOR CONTROLLED FREEZING 9000 LL100 Multi-Tip Cryofreezer, in fitted case N20/E fitting LLCO2 Multi-Tip Cryofreezer, in fitted case CO2/E fitting Gas Cylinder Cart (for E type cylinder) Handwheel for "E" cylinder Fitted carrying case CRYO-TIPS: Each T-0219 Microderm T-1905 Exocervical T-0219 Cone T-1920 Exo Endocervical T-0524 Bevel T-1910 Exo-Endocervical T-0519 Condyloma T-1920 Long Exo-endocervical T-0832 Procto Flat T-2500 Flat T-0819 General Purpose T-2507 Exocervical T-0826 Cone T-2514 Exo-Endocervical T-0823 BEVEL T-0832 Procto Curved T-1900 Flat HPV TIPS: T mm Discontinued T mm T mm T mm T mm T mm Tip Protector for LL Sterilisation Plugs for tips 12 per carton HOSE Scavenger Hose 10mm -5m AA Disposable plastic sheaths for tips 100 per carton: each VAT and carriage to be added to the above prices

22 ULTRAFREEZE PRICE LIST FOR SPRAY FREEZING - ULTRAFREEZE Ultrafreeze Liquid Nitrogen Spray (500ml capacity) Mini Ultrafreeze Nitrogen Spray (300ml capacity) Spare Spray Apertures for Ultrafreeze Set of 4 comprising : x g 3" Curved Blue 1 x g 3" Straight Blue 1 x g 1 1 / 2 " Curved Green 1 x g 1 1 / 2 " Straight Green mm Flat closed tip for UltraFreeze mm Flat closed tip for UltraFreeze mm Flat closed tip for UltraFreeze mm Flat closed tip for UltraFreeze Accu-Shield - concentrates spray within a limited area) (set of 6 varied cones) VAT and carriage to be added to the above prices All UK support available from: Genesis Medical Ltd 7 Trojan Business Park Cobbold Road London NW10 9ST Tel: Fax: mail@genmedhealth.com