RM4 - Waters

Hypothermic Oxygenated Machine
Perfusion of either one or two kidneys

Pulsatile pressure

The linear pump mimics the heart and produces a physiological pressure waveform with a clearly identifiable dicrotic notch.

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Parameters monitoring

The system monitors perfusion solution flow, temperature, pressures (systolic, mean, and diastolic), and renal resistance during preservation, offering clinicians additional data to evaluate the organs.

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Data control

Perfusion data are accessible in real-time through the unit interface. Data are stored in the RM4 control unit and transferrable onto a flash drive.

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Oxygenation

Active oxygenation of the Waters IGL® Pulsatile Perfusion Solution by sweeping air over a membrane oxygenator, allowing unbroken delivery of oxygen to the organ. Option to connect to Oxygenation Cylinder or oxygen from wall outlet available.

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Extended procedure

The ice reservoir is detachable and can be refilled at any time during the perfusion, should the perfusion procedure be extended.

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Cooling

The heat exchanger cools the Waters IGL® Pulsatile Perfusion Solution. The hypothermic conditions slow down the metabolism and then decrease cellular degradation.

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Kidney cannulation

Kidneys are cannulated by the renal artery. Different types of devices are provided to suit all anatomies: clamp for organs recovered with aortic patch, cannula for organs recovered without aortic patch, and multiple arteries connector.

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4 5

6 7

1. Pulsatile pressure +-

The linear pump mimics the heart and produces a physiological pressure waveform with a clearly identifiable dicrotic notch.

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2. Parameters monitoring +-

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3. Data control +-

Perfusion data are accessible in real-time through the unit interface. Data are stored in the RM4 control unit and transferrable onto a flash drive.

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4. Oxygenation +-

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5. Extended procedure +-

The ice reservoir is detachable and can be refilled at any time during the perfusion, should the perfusion procedure be extended.

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6. Cooling +-

The heat exchanger cools the Waters IGL® Pulsatile Perfusion Solution. The hypothermic conditions slow down the metabolism and then decrease cellular degradation.

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7. Kidney cannulation +-

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RM4 is an FDA-cleared medical device.

Waters IGL® Pulsatile Perfusion Solution

Waters IGL® Pulsatile Perfusion Solution is formulated with buffer (calcium chloride), impermeants (mannitol, dextrose, sodium glucontate, magnesium gluconate), precursors of ATP (ribose, adenine), Free-radical scavenger (gluthatione) and colloid (Hydroxyethyl starch).

Waters IGL® Pulsatile Perfusion Solution continually circulates through the vascular vessels of the kidney, allowing removal of cell fragments and unbroken delivery of oxygen and substrates. The ion-pump activity as well as the metabolism, including adenosine triphosphate (ATP) synthesis, are maintained.

Ingredients	Amount
Adenine (free base)	0.68 g/L
Calcium Chloride (dihydrate)	0.068 g/L
Dextrose (+)	1.80 g/L
Glutathione (reduced)	0.92 g/L
HEPES (free acid)	2.38 g/L
Hydroxyethyl Starch	50.0 g/L
Magnesium Gluconate (anhydrous)	1.13 g/L
Mannitol	5.4 g/L
Potassium Phosphate (monobasic)	3.4 g/L
Ribose, D(-)	0.75 g/L
Sodium Gluconate	17.45 g/L
Sodium Hydroxide	0.70 g/L
Sterile Water for injection	qs 1 litre

Physiologic system

Pulsatile arterial pressure and oxygenation of the perfusate to simulate human physiology

Dual perfusion

An obvious cost-saving and convenient procedure for centers with any number of transplant

Convenient interface

Equipped with a large touchscreen interface to walk the user, minimizing significantly setup and training time.

Clinical benefits

RM4 inherits the Waters Hypothermic Machine Perfusion technology which is beneficial to marginal donor kidneys, leading to more favorable immediate graft function and delayed graft function compared to static cold storage. Immediate graft function is defined by serum creatinine falls of more than 20% in the first 24 hours post-transplant. Delayed graft function is defined as the need for dialysis within 7 days of transplantation.

90
71.8

Immediate function rate (%)
p=0.057

Light JA Clinical Transplantation June 1996 ; 10(3) 233-6

Delayed Graft function (%)
p=0.002

Stratta RJ J American College of Surgeons May 2007 ; 204(5) : 873-82 ; discussion 882-4

Waters Machine Perfusion

Static Cold Storage

Training videos

+-Entering user information

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+-Placing the organ cassette

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+-Activating the cooling pump

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+-Loading the perfusate circuit

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+-Priming the perfusate circuit

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+-Cannulating the kidney – with patch

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+-Cannulating the kidney – without patch

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+-Cannulating the kidney – with multiple vessels

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+-Placing the Kidneys

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+-Setting perfusion pressure

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+-Locking/unlocking screen

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+-Turning on/off sound alarm

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+-Setting system

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+-Ending perfusion

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+-Visualizing the perfusion data

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+-Transferring the perfusion data

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+-Draining the ice reservoir

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+-Cleaning up after perfusion

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+-Swapping batteries

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+-Retrieving a perfusate sample

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+-Injecting medication into sample port

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Testimonials

“Dual perfusion is an obvious cost saving factor.”

- Cheryl "Cherie" Cook

Certified Transplant Preservationist

“The Waters Medical Systems RM3 is the only kidney preservation system currently on the market that gives a true cardiac pulse wave. It is the only kidney preservation system that is capable of perfusing a wide variety of organs including enbloc pediatric kidneys, expanded criteria kidneys, and kidneys from DCD trauma donors with up to 2 hours of warm ischemic time. We successfully preserved these kidney types and found immediate functioning allografts at transplant.”

- Fred Gage, PhD

Clinical Research Coordinator

“The RM3 system is a great pulsatile preservation machine. We trust it and love it.”

- Nai-Ning Liang

Senior Director, Pulsatile Preservation

“The Waters Medical Systems machines are rugged and dependable beyond all expectations. The clear perfusion chamber gives the user an advantage over other devices of this type. Namely, being able to visualize the organ the entire time it is being perfused.”

- James Turturice, III

Organ Preservation Lab Manager

“The Waters Medical Systems RM3 has been an extremely reliable workhorse for our busy program over the years. Easy to set up and the only device on the market that allows for back-table work while on the pump.“

- Stuart Grant-Coons

Certified Clinical Perfusionist