Organ recovery systems LifePort Kidney Transporter LKT101P, Operator'S Manual, Page: 57 / 65

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Page: 57 / 65

Organ recovery systems LifePort Kidney Transporter LKT101P Operator'S Manual Download Page 57

755-00002 Rev K

LifePort Kidney Transporter Operator’s Manual

57

Device Classifications

Equipment is suitable for Continuous Operation.

CAUTION:

Equipment is

NOT

suitable for use in the presence of a

FLAMMABLE ANESTHETIC

MIXTURE WITH AIR

,

OXYGEN

or

NITROUS OXIDE

.

Electromagnetic Compatibility

LifePort Kidney Transporter needs special precautions regarding electromagnetic compatibility (EMC)
and should be used in accordance with the EMC information provided in this manual.

LifePort Kidney Transporter can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio or television reception.
However, there is no guarantee that the interference will not occur in a particular installation. LifePort Kid-
ney Transporter does cause interference, which can be determined by turning LifePort Kidney

Transporter on and off, try to correct the interference by one or more of the following measures:

•

Reorient the receiving antenna.

•

Increase the distance between LifePort Kidney Transporter and receiver.

•

Connect LifePort Kidney Transporter to an outlet on a separate circuit from that to which the
receiver is connected.

Portable and mobile RF communications equipment can affect LifePort Kidney Transporter.

WARNING:

To assure compliance with EMC requirements, use only manufacturer-supplied cables,

as shown below. If you have questions, contact the Organ Recovery Systems Perfusion Helpline.

Data Cable

Part # AK67222

Power Cord

Part # 17664 (US only, contact the Organ Recovery Systems Perfusion

Helpline for international Power Cord part numbers)

WARNING:

Use of Power Cords or communications cables, other than those specified, may result in

increased emissions or decreased immunity of LifePort Kidney Transporter.

WARNING:

LifePort Kidney Transporter should not be used adjacent to or stacked with other

equipment and if adjacent or stacked use is necessary, LifePort Kidney Transporter should be

observed to verify normal operation in the configuration in which it will be used.

Medical Device

Class II

FDA listed device

Class IIa

MEDDEV EU Directive
93/42 EEC

Type of protection from
electric shock

Class I / Internally Powered

Protection from water
ingress

IPX1

LifePort Kidney Transporter is
protected from vertical water droplets

Cleaning recommendations

LifePort Kidney Transporter can be cleaned with a 70% Isopropanol
solution to remove perfusate residue and other detritus.

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Summary of Contents for LifePort Kidney Transporter LKT101P

Page 1: ...LifePort Kidney Transporter Operator s Manual 1 1...

Page 2: ...T 1 847 824 2600 T 32 2 715 0000 T 55 11 3586 6259 F 1 847 824 0234 F 32 2 715 0009 F 55 11 3586 4944 Perfusion Helpline Perfusion Helpline Perfusion Helpline 1 866 682 4800 32 2 715 0005 55 11 98638...

Page 3: ..._____________________________________ Contact____________________________________________________________________ Model Number______________________________________________________________ Serial Numb...

Page 4: ...Kidney Transporter Disposable Kidney Cannulas 13 LifePort Kidney Transporter Disposable Kidney Sterile Drape 13 Operational Accessories 13 Power Cord 13 Batteries 14 Battery Charger Optional 14 Data C...

Page 5: ...traight cannula 29 Using the Disposable Kidney Coupler 30 Using the Disposable Kidney Universal SealRing cannula 32 Placing the Kidney in LifePort Kidney Transporter 34 Entering ORGAN ID Information 3...

Page 6: ...plant 45 Capturing and Downloading Data Optional 48 Introduction 48 To Flash Drive 49 Downloading a File 49 Troubleshooting and Diagnostics Troubleshooting Procedures 50 Error Message Explanations 51...

Page 7: ...ual should be carefully followed for safe trouble free and effective equipment use This manual provides the essential information necessary for installation operation and routine servicing of LifePort...

Page 8: ...e following table A Amperes AC Alternating current A hr Ampere hours C Degrees Celsius cm Centimeter 1 cm 01 m L Liter 1L 0 001 m3 lb s Pound 1 lb 0 45 kg LCD Liquid Crystal Display LED Light Emitting...

Page 9: ...creens illuminate when the power is on Stop Wash Prime and Infuse controls are provided and identified depending on the mode and options available Acceptable operating ranges are established within Li...

Page 10: ...filled with a mixture of ice and water to provide a stable cold temperature environment for the kidney Pump Deck The Pump Deck is the fluid management area of LifePort Kidney Transporter On the Pump D...

Page 11: ...lude Computer Batteries and battery charger Communications interface Sensor interface Power supply a hospital grade Power Cord is supplied do not substitute Pump and valve driver circuits Fan External...

Page 12: ...side front cover for contact details The primary Kidney Disposables are shown separated for easier visualization in the illustration below A full description follows 30 18 PRESSURE mmHg 120 FLOW ml mi...

Page 13: ...erfusate or inject fluids without opening the Perfusion Circuit Pressure Sensor and Connector a flow through pressure sensor within the Infuse Line that measures perfusate pressure within the Perfusio...

Page 14: ...in charger will replenish the batteries whenever the LifePort is plugged into an external power supply It s a good idea to plug in the LifePort whenever not in transit keeping the batteries at the hig...

Page 15: ...ce Model Number Serial Number Lot Number Sterile method is ethylene oxide CAUTION Consult Accompanying Documents Do not reuse Risk of contamination infection or potential serious hazard if single use...

Page 16: ...s to a sink for clean up and to provide water for the ice bath Easy access to medical waste disposal Easy access to refrigerated storage for perfusate and other medications Tabletop space for Battery...

Page 17: ...possible into the ice bath 2 Pour about 1 0 Liter of cold water less than 10 C into the Ice Container which will gradually loosen the ice 3 Add more ice and another 0 5 1 0 Liter water until the Ice...

Page 18: ...lue of 30 mmHg Mode control displays show WASH PRIME and INFUSE On the Outer Display panel observe the following The Outer Display panel screens illuminate The values displayed read PRESSURE 00 FLOW 0...

Page 19: ...or smaller syringe needle will also work You must make an entry under ORGAN ID KIDNEY and BLOOD TYPE before you can run an Infuse test 1 Press OK to enter ORGAN INFORMATION 2 Make sure ORGAN INFORMAT...

Page 20: ...out the entire 24 hour duration of the test Entering Device Information 1 Press OK then use the arrow buttons to select DEVICE INFORMATION 2 Make sure DEVICE ID is selected use arrow buttons if necess...

Page 21: ...ifePort Kidney Transporter such as renal resistance and temperature allowing customers to vigilantly monitor the kidney as it travels to its destination Access to the customized portal will be setup p...

Page 22: ...ore you receive the call that LifePort Kidney Transporter is needed keep it ready to go at a moment s notice by performing the following procedures Preparing the Home Base Station LifePort Kidney Tran...

Page 23: ...the kidney USE ONLY ICE AND WATER in LifePort Kidney Transporter Ice Container A mixture of ice and water in the Ice Container will assure that temperatures remain within the appropriate range for kid...

Page 24: ...for two operators one being gowned and gloved In the case of a single operator pay special attention to procedures performed inside an aseptic field CAUTION Use Aseptic Procedures with LifePort Kidney...

Page 25: ...Deck 9 Open the Pump Head and stretch the tubing over the wheel 10 Close and latch the Pump Head Loop to clamp the tubing 11 Rotate the Pump Deck Locking Arm and snap into place 12 Connect the Pressur...

Page 26: ...orter Operator s Manual 755 00002 Rev K 26 16 Close and latch the Cover NOTE If the Outer Display panel shows an error reference the error number shown following in Troubleshooting and Diagnostics on...

Page 27: ...o the perfusion record NOTE If a non sterile assistant is not available write the anomalies initially on the sterile table covers Transfer the information to the perfusion record as soon as the proced...

Page 28: ...tic patch Choose the size appropriate to the aortic patch NOTE Patches that contain multiple arteries may be able to be placed into one SealRing cannula NOTE Perform the following procedure on an asep...

Page 29: ...secure the organ in the Kidney Cradle Using LifePort Kidney Transporter Disposable Kidney Straight Cannula INDICATIONS FOR USE The Straight cannula is used when the vessel to be perfused terminates w...

Page 30: ...el 7 Visually inspect the vessel ensuring there are no twists or occlusions 8 Drape the Mesh Organ Restraint over the kidney and secure the organ in the Kidney Cradle Using LifePort Kidney Transporter...

Page 31: ...la halves and fix the straps to their posts 7 Gravity flow small amounts of flush solution into the cannula then check for and repair any leaks that occurred in the surgical process or with the cannul...

Page 32: ...patch Choose the size appropriate to the diameter of the vessel orifice NOTE Perform the following procedure on an aseptic field using aseptic technique 1 Using standard aseptic technique introduce th...

Page 33: ...and fix the straps to their posts 5 Gravity flow small amounts of flush solution into the cannula then check for and repair any leaks that occurred in the surgical process or with the cannula 6 Place...

Page 34: ...HHMMSS 2 KIDNEY TYPE will default to NA 3 BLOOD TYPE will default to NA When downloading files to a USB stick the files stored in the LifePort will be identified on the display with the ORGAN ID eithe...

Page 35: ...the same surgical field used when placing the kidney in the Kidney Cradle 1 A person outside the aseptic field remove the Outer Lid from the Perfusion Circuit 2 Using aseptic technique position the f...

Page 36: ...e to prime the Infuse Line removing bubbles from the line and renal artery This procedure is performed using aseptic technique NOTE For better clarity the following illustrations of the Perfusion Circ...

Page 37: ...it The Pump should automatically stop and beep If the Pump does NOT stop and beep it means there is a leak Preliminary Testing for Leaks Once LifePort Kidney Transporter begins pumping you have your f...

Page 38: ...After Placement Once you have the kidney in LifePort Kidney Transporter there are several simple checks to verify that cannulation and placement are optimal during perfusion Visual Inspection There a...

Page 39: ...u detect a slow leak somewhere but a large volume is coming from the vein there may be no reason to be concerned Presence of Blood or Perfusate Observe the progress and efficacy of the pumping process...

Page 40: ...y and record on the chart per hospital procedure 7 Verify that LifePort Kidney Transporter is in INFUSE mode 8 Attach a handle tag or similar approved label to place identification information on the...

Page 41: ...es as ice bath values increase and is only displayed during active infusion Press the PLOT CLEAR button on the far left side of the display panel to temporarily display trending data for flow and resi...

Page 42: ...on dashboard The Data Station is capable of monitoring multiple LifePort Kidney Transporter s Consult the Data Station User Guide for more information on how to display perfusion information and how t...

Page 43: ...to achieve the indicated pressure and should never exceed this setting to avoid barotraumas or specifically endothelial injury Leakage at Cannula or Open Side Branch This graph shows immediate flow b...

Page 44: ...N Keep LifePort Kidney Transporter upright during transportation Avoid direct sunlight and hot or cold temperature extremes Extended exposure to outdoor conditions sunlight heat or cold can affect the...

Page 45: ...ll times Waiting until Recipient Surgery Is Ready If there is a waiting period before the recipient surgery is ready the kidney is perfused and monitored inside LifePort Kidney Transporter to maintain...

Page 46: ...ngth of LifePort Kidney Transporter 5 Using aseptic technique fully unfold the Sterile Drape side to side 6 Using aseptic technique position the Sterile Drape opening down around the covered Perfusion...

Page 47: ...press the STOP button to stop the flow 4 Using aseptic technique carry the Kidney Cradle to the sterile field 5 Using aseptic technique unhook the Mesh Organ Restraint Option B continued 3 Using asep...

Page 48: ...panel on the back of the unit Whenever LifePort Kidney Transporter is in Infuse Mode its internal computer is capturing perfusion and status data once every 10 seconds Data recording begins when Life...

Page 49: ...data file you can download the file onto a flash drive then later evaluate the data in a computer when one is available Downloading a File 1 Power on LifePort Kidney Transporter 2 Insert USB flash dri...

Page 50: ...not resolved call Organ Recovery Systems Perfusion Helpline Beeping or flashing LEDs Errors detected internally by LifePort Kidney Transporter Follow the instructions in the Error Message Explanation...

Page 51: ...aks and loose fittings Re prime the Perfusion Circuit and kidney under aseptic conditions Can t Reach Pressure LifePort Kidney Transporter cannot achieve the set arterial pressure Leaking cannula or a...

Page 52: ...tor Current Failure Pump not responding normally Call the Organ Recovery Systems Perfusion Helpline Near Freezing The Ice Container Temperature Sensor is reading below 0 1 C Incorrect coolant Use ice...

Page 53: ...LifePort Kidney Transporter into a warmer environment 2 If problem is not resolved a sensor failure may exist Call Organ Recovery Systems Perfusion Helpline Too Much Pressure Pressure Sensor is seeing...

Page 54: ...idney Transporter by reinstalling the batteries and the mains Power Cord If the POST message continues to display call the Organ Recovery Systems Perfusion Helpline POST Error Message Indication POST...

Page 55: ...connectors the ventilation holes or the Battery area CAUTION Ice Container and Lid are re usable parts of LifePort Kidney Transporter which needs to be cleaned and dried after each case This is not a...

Page 56: ...d loop pressure regulation 10 to 65 mmHg Perfusion Modes Pulsatile Flow Rates 0 to 240 mL min maximum rates decrease by 25 when powered by batteries Dimensions 24 x 14 5 x 14 25 61 96cm x 36 83cm x 36...

Page 57: ...n a separate circuit from that to which the receiver is connected Portable and mobile RF communications equipment can affect LifePort Kidney Transporter WARNING To assure compliance with EMC requireme...

Page 58: ...etic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic mate...

Page 59: ...is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radi...

Page 60: ...n from structures objects and people Operational Precautions and Limitations The following information will affect the success in using LifePort Kidney Transporter Should Be Used Only By Trained Profe...

Page 61: ...the Medical Device Directive 93 42 EEC and to the Electromagnetic Compliance EMC Directive 89 336 EEC These limits are designed to provide a reasonable protection against normal interference in a com...

Page 62: ...ecautions with the kidney and perfusate The kidney and perfusate may carry undetected from the donor Use proper precautions e g gloves masks gowns goggles or equivalent eye protection biohazard bags i...

Page 63: ...nections External 11 Control Panel 11 Coolant Source 56 Cooling Down the LifePort 23 Coupler 30 Data Cable 14 Download 56 Port Connection 11 14 Description 9 56 Diagnostics 50 Dimensions 56 Display Ou...

Page 64: ...the Kidney in the LifePort 34 Power Button 15 Cord 13 Source 56 Status Outer Display 12 Power on Self Test POST Failure Error Message 52 Preliminary Tests Running 16 Preparing Home Base Station 22 To...

Page 65: ...LifePort 43 Universal Precautions Use of 55 Universal SealRing Cannula 32 Unpacking Setup and Preliminary Testing 16 Unresponsive buttons Trouble 50 Use Intended 9 Valve Infuse 11 Wash 11 Vein Positio...

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