Dialysis products 9/ 2014

SHK MedicalDialysis Support Range.

For Dialysis we offer the following consumables and supporting equipment

Hemodialysis blood lines: Gambro, Fresenius, Nipro, Baxter & Universal fitting

AV Fistula needles: Several Gauges and options for fixed or rotating wing.

Dialyzers: LF, HF, Balanced Flux, Various sizes all using German Membrana filters

Bicarbonate Cartridges / Bags: For Gambro and Fresenius machines

Bicarbonate and Citrate concentrates: For Gambro, Fresenius, Nipro machines

Dialysis Catheters: Long and Short term types, single to triple lumen type.

Renal Trays: Or On/Off kits as often referred to, in our standard spec or custom made

Infusion Sets: IV sets

Disinfectants / Sterilant: For use in dialysis machines, and others for surface use.

Saline solution in 500ml bags

Blood Bags: Single to Quadruple bags

Reverse Osmosis units: From small scale stand alone to large scale systems for dialysis use.

Dialyzer reprocesser: To allow the re-use of quality dialyzers for the same patient.

Blood Glucose meters: CE & FDA approved meters.

If any item is not listed please call or write to us.

SHK Medical A46 Fosseway Six Hills, Leicestershire LE13 4PD. T +44 116 350 0066 F +44 709 204 1347 E - [email protected] SHK Medical Fze P. O. Box 122080 Sharjah UAE T +971 50 787 2259 E - [email protected] W - www.shkmedical.com


Images of Blood Tubing sets


Specification of Blood Tubing sets


Images of AVF needles

Feature

1. Ultra wall and siliconized fistula needle with or

　 without back eye.

2. Unique process on blade to reduce pain and skin

　 damage occurred at the time of puncture.

3. Flexible fixed or rotating wing for easy slip-free

　 puncture operation.

4. Clear kink resistant tube fitted with female Luer

　 lock and pinch clamp.

A.V. Fistula needle set components


Specifications of AVF needles


Dialyzers

Our products include 3 levels of Dialyze efficiency • Low flux • Balanced flux • High flux Fulfilling any requirement of renal failure treatment.The PES hollow fibre of the High flux and Balanced flux are manufactured by MEMBRANA with Performance Enhancing Technology (P.E.T.) The PS hollow fibre of the Low flux is manufactured by Trillium. We also have transferred the assembly plant and technology from our partner. Alpha Plan GmbH, Germany.

SHK Medical is the Sole Official Distributor for Middle East and Africa.

BICARBONATE CARTRIDGEFor Gambro HD machine

In multiple SizesGeneral description

- The cartridge is a polypropylene column containing sodium bicarbonate which enables on-line production of liquid bicarbonate concentrate. - Hermetically sealed package ready for the on-line preparation of liquid bicarbonate solution - Suitable Mesh filter for easy piecing - Filters: one filter on the inlet and one filter on the outlet port of the cartridge - End caps open – no membrane to spike therefore reducing the risk of damage to the machine - P.P caps on both ends of the cartridge to avoid moisture, to be removed before use

- Specifications Contents:Each cartridge contains min. 650 g of sodium bicarbonate powder (Eur. Ph. grade). Capacity:Together with a suitable acid concentrate each cartridge will yield enough sodium bicarbonate solution to produce 300 l of dialysis fluid with a bicarbonate concentration of 34 mmol/l. Ren Cart, 650 gms. equivalent to 6.5 litres, bicarbonate concentrate 8.4% with dialysis time of about 7 hrs. Storing: Store below 50oC. Shelf life: 36 months from the date of manufacturing

- Q.C & Q.A Follow cGMP strictly which includes: Inspection of components, Process control, Lab testing, Inspections & Documentation

- Requirements on acid concentrate The acid concentrate must be designed for use with pure sodium bicarbonate concentrate and have a dilution ratio of 1:35 (1+34) or 1:36.83 (1.83+35) or 1:45 (1+44).


SHK Medical is the Sole Official Distributor for Middle East and Africa.

BICARBONATE BAGFor Fresenius HD machines

General description

- The bag containing sodium bicarbonate which enables on-line production of liquid bicarbonate concentrate. - Hermetically sealed package ready for the on-line preparation of liquid bicarbonate solution - Easy to use, practical and lower storage costs, with a 36 month shelf life.

- Specifications Contents:Each cartridge contains min. 650 g of sodium bicarbonate powder (Eur. Ph. grade). Capacity:Together with a suitable acid concentrate each cartridge will yield enough sodium bicarbonate solution to produce 300 l of dialysis fluid with a bicarbonate concentration of 34 mmol/l. Bi - Bag, 650 gms. equivalent to 6.5 litres, bicarbonate concentrate 8.4% with dialysis time of about 7 hrs. Storing: Store below 50oC. Shelf life: 36 months from the date of manufacturing

- Q.C & Q.A Follow cGMP strictly which includes: Inspection of components, Process control, Lab testing, Inspections & Documentation

- Requirements on acid concentrate The acid concentrate must be designed for use with pure sodium bicarbonate concentrate and have a dilution ratio of 1:35 (1+34) or 1:36.83 (1.83+35) or 1:45 (1+44).


CITRATE CONCENTRATE

INTRODUCTION:

REN-CIT is Bicarbonate Hemodialysis Concentrate which contains Sodium Citrate as buffering agent replacing significant amount of Acetate, normally present as buffer. The quantity of Sodium Citrate is very low as compared to that needed for systemic anti-coagulation hence its anti-coagulatory effect is only in extra-corporeal circulation.REN-CIT Part-A is available in solution form & Part-B in powder form. REN-CIT-DRY is available in powder form (Part-A & Part-B).

ADVANTAGES:

Compared with traditional Hemodialysis Concentrates, “REN-CIT Citrate Concentrate” has the following benefits:Reduces Heparin need in dialysis patients (upto 40%)• Increases dialysis dose Kt/V (>1.2) and URR (>70%)• Significantly reduces in case of Heparin-free Hemodialysis• Better Kt/V in case of Dialyzer Reuse due to better clearing of fibres• No of Dialyzer Re-use increases significantly (60-100%)• Does not cause Thrombocytopenia• No Heparin Antibodies• Reduces cost of Heparin• Significant reduction in bleeding episodes if Heparin is eliminated or reduced • No Heparin-related complications viz Osteoporosis, Pruritis, disturbed LipidMetabolism• Significantly less or no clotting in patients with frequent dialyzer clotting• Elimination of Acetate-related complications (present as buffer in Concentrates) • Anti-oxidative effects• Improved acid-base status• Reduced inflammation• Reduction of Pre-dialytic Beta-2-Microglobulin levels• Improved tolerance to treatment• Heparin-induced Myeloperoxidase release causes atherosclerosis propagationnot present with Citrate concentrate• Can be used in Liver Failure patients undergoing Hemodialysis

INDICATIONS:

• Routine Hemodialysis due to its advantages • Active Bleeding employing Heparin-free hemodialysis • Suspected bleeding or risk of bleeding • Disturbed clotting profile • Absolute or relative contra-indication of Heparin • Frequent Dialyzer clotting • Heparin Allergies • Low Platelet count • Targeting of better Kt/V with Dialyzer Re-use & increase in number of reuses • Pre- and Post-surgical patients


• Patients with gastro-intestinal bleeding or active ulcers • Patients with Hemorrhagic Retinopathies • Patients with Acetate-related complications like frequent episodes of hypotension, arrhythmias,

nausea, etc. • Old, malnourished patients or those getting Hemodialysis for several years more prone to Acetate

toxicity • Patients with Heparin-related side-effects viz pruritis, osteoporosis, accelerated atherosclerosis, etc. • Hemodialysis in Liver failure patients with disturbed bleeding/clotting profile

Guidelines for Use:

• REN-CIT contains a small amount of anticoagulant (Citrate) which prevents clotting in the extracorporeal circuit without increasing bleeding tendency.

• Citrate dialysate can only be prescribed by, or on order of a physician. • Before use check label, proportioning ratio (35-X; 36.8-X; 45X) and formulation • Use cartridge or B-Part concentrate as usual. • To achieve adequate anti-coagulation Dialysate flow may be increased to 600ml/minute. • Micro-bubbles cause increased clotting of fibres/circuit hence make sure no air (micro

bubbles) are in the extracorporeal circuit before connecting the patient and during dialysis. • Reduce the Heparin dose in steps until required ACT or a PTT levels are achieved. • In case of Heparin-induced Thrombocytopenia or Heparin allergy stop Heparin and use saline

flushing along with use of REN-CIT Concentrate to avoid clotting and achieve adequate clearances.

• Pay special attention to the Venous pressure and clotting in lines if Heparin eliminated or significantly reduced.

• If there is tendency of frequent clotting of Dialyzer/lines, REN-CIT can be used with the normal Heparin dose.

• If REN-CIT Part-A solution is still available after Dialysis it can be used for the next Dialysis session.

• Electrolytes like Calcium, Potassium can be added in Part-A as per Physician’s choice.

Caution:

Rarely in case of very low Calcium in patient’s blood signs of Hyo-Calcemia may appear. Calcium binds with Citrate and hence use of Citrate dialysate will temporarily, during dialysis only, decrease ionized Ca levels by approximately 10%.Assess the patient during treatment for signs of hypocalcemia: numbness/tingling around the mouth, spasm of hand muscles (Tetany), unusually long and strong muscle cramps(not related to Hypo-Natremia). If symptoms occur, place the hemodialysis machine in bypass and give I/V Calcium Gluconate slowly although even otherwise symptoms should resolve in minutes as Citrate is quickly metabolized in the body. *

* Independent medical supporting documents can be sent to you on request.


POWDER HEMODIALYSIS CONCENTRATE

Part A-Powder; Part B-Powder; Part C-Acetum (liquid Acetic Acid BP/USP to be added in Part-A during Mixing)Packing:

Individual Packs Part-A Powder for 5 Dialysis sessions (typically) or as per your choice, packed in Pharma-grade LDPE soft bags.Individual Packs Part-B Powder for 5-Dialysis sessions (typically) or as per your choice, packed in Pharma-grade LDPE soft bags.Finally Packed in Strong Cartons.

Any formulation for any brand of machine as per customer's choice.Quantity:

Minimum one 20 feet container load consisting of powder Concentrate for 11,000 Hemodialysis sessionsQuality CertificationQuality Analysis certificates will be sent with the consignment endorsed by our Ministry of Health, wherever required.Advantages to Patients & Society Less Volume, Less Freight, Easy Handling by Individual, Less Cost, Easy Storage Less Breakage/Damage During Shipment Environment-friendly as compared to canisters due to significantly less wastage of disposal Requirement of high-quality RO water for mixing Ren-pulv makes it mandatory for Dialysis Centre's in developing countries to Keep RO Plant in good condition, an advantage for patients. Available in Custom Formulations & Packs

Mixer unit

We can provide Fully-automated, PLC-controlled, Touch-button, Stain-less Steel Mixers for mixing Part-A and Part-B Concentrates for mixing 25 and 50 Dialysis sessions powder. Instruction Manual will be available in English or language of your choice.Moreover, cheaper versions of Mixers, stainless steel, but manually operated in few steps are also available.Mixers will be provided on subsidized prices to facilitate the customers.Services

In case of good sales contract our Director (Kidney Physician) can visit the respective country for Trials, Training, meeting with doctors, Training of Sales/marketing persons, Lectures on Prescription Dialysis/Quality of Dialysis, etc.Wall poster related to "Good Hemodialysis" will be provided for Dialysis Centre.Our Technical/Medical staff is available on phone or via e-mail or Fax for the end-users in case of any difficulty.

BICARBONATE HEMODIALYSIS CONCENTRATE SERIES

Part A & B are in powder form + Acetum (Acetic Acid) is in liquid formPart A & B can be provided in custom-made formulations & custom-made packs according to the needs of individual dialysis centre’s. Presently packs for 5, 10, 15, 20 & 25 patients have been introduced to be mixed in R.O water. It will further cut down the cost up to 25-30% as compared to conventional Hemodialysis solutions provided in cans.


GENERAL MEDICAL DISINFECTANT TABLETS

• From tablet to 500 ml working disinfectant in 10 minutes. • Space saving solution, each box contains 25 tablets. • Re-useable UV resistant bottle ensures no degradation of the product once mixed.

HOSPITALS~ DENTAL~CLINICS~VETERINARY~HOTELS~FOODSOS Safe on Skin

A biocidal activity against a broad spectrum of bacteria, virus and fungiA high number of microbiological test reports according to EU Standards certify its biocidal efficacyDestroys microorganisms irreversibly and excludes the build-up of resistanceHas no mutagenic or toxic potentialNot harmful to skinThe recommended solution is not corrosive to materials,It can be used even on sensitive materials such as acrylic glass, plastics and rubberSimple to use and easy to doseIt acts through the mechanism of oxidationA solution once prepared remains active for up to 4 weeks · biodegradable

Used for all types of surfaces, medical devices and non- invasive appliances / instruments which can be immersed, rinsed, sprayed or wiped down.

It is ideally suitable for risk areas where one needs a user and material friendly surface disinfectant with a broad spectrum of effectiveness.

Your Tosil med solution splits its chlorine molecule offonly when it comes into contact with a protein-structure (microorganisms). For the user this means

that once prepared, a TOSIL solution remains stable and active for up to 4 weeks. Once it has acted against its target the molecule disintegrates into readily biodegradable substances like:

nitrogen (N2), sodium sulfate (NA2SO4) and carbon-dioxide (Co2).Tablet shelf life of 3 years from production (kept at temperatures below 25c)

15 years of use in UK hospitals Developed in Germany

MSDS sheets and clinical studies available on request.


Automatic mixerSpecifications:

1..Easy operation, Single-push automated function. 2..PLC is programmed as per requirement. 3..Stainless Steel body to avoid rust and maintain cleanliness.4..High-accuracy water level sensors.5..LCD and Beeps tell about the ongoing process and completion.6..Stain-less Steel high flow Pump for speedy and complete mixing.7..Stain-less steel Solenoid valves for different stages of automated mixing.8..All wires concealed in the pipe and in the mixer base. 9..Automatic Filtration process during the second phase of mixing.10..EXTENDED MIXING option in case operator senses incomplete mixing.11..Cans are filled through filtration process to avoid any insoluble matter entering the can.12..Automated one button RINSE feature to be employed as needed.RO water is used for rinsing.13..Options may be provided to make different volumes in the same mixer as per requirement.14..Cone-based bottom for complete emptying.15..Parts easily replaceable and available with the company. 16..Available in different sizes for preparing 60,100 and 200 litres Part-A Concentrate solution.17..Mixer is Securely and professionally packed for export to avoid damage.

Semi - automatic mixerSpecifications:

1..Easy operation.2..Stainless Steel body to avoid rust and maintain cleanliness.3..Good-accuracy.4..Stainless Steel high flow Pump for speedy and complete mixing.5..Cone-based bottom for complete emptying.6.. Easy to Disinfect.7.. Available in different sizes.8.. Mixer is Securely and professionally packed for export to avoid damage.9.. Parts easily replaceable and available with the company.


BLOOD BAGS

All blood bags carry CE, ISO, TUV, GMP certification.

SterileNon - toxic pyrogen freeTransparent sterile unit packaging in aluminium foil16G ultra - thin wall, short bevel angled donor needle ensuring maximum donor comfort.Each donor bag contains CPDA-1(citrate-phosphate-Dextrose-Adenine) which preserves red blood cells up to 35 daysFor separation of three components from whole human blood.

Available in:

SingleDouble Triple Single transfer bagsPaediatric bags

Sizes 250ml, 350ml, 450ml capacity.Packing:each set packed in a PET compounded vacuum bageach 3 sets are packed in aluminium foil compound bag

Image of Label on Blood Bag

SHK Medical Six Hills, Leicestershire LE14 3PD. T +44 116 350 0066 E - [email protected] W - www.shkmedical.com

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Dialysis products 9/ 2014

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