Medtronic ATL2001 Instructions for Use

autoLog IQ™

0123

Autotransfusion System

User Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective
owners.

autoLog IQ, Medtronic

Contents

1 Explanation of packaging, labeling, and device symbols ..................................... 5

2 Introduction .................................................................. 7

2.1 Advantages of autotransfusion over allogeneic transfusion ...................................... 7

2.2 Principles of operation ........................................................... 8

3 Intended use .................................................................. 9

4 Contraindications .............................................................. 9

5 Warnings and precautions ......................................................... 9

6 Adverse effects ............................................................... 11

7 Device description ............................................................. 11

7.1 Device components ............................................................ 11

7.2 Items included with the device ...................................................... 17

7.3 Optional items not included with the device .............................................. 17

7.4 Audible alert signals ............................................................ 17

7.5 Visual alert signals ............................................................. 17

8 In vitro performance ............................................................ 18

9 Transportation and storage ....................................................... 18

9.1 Transporting the device .......................................................... 18

9.2 Transporting the device between clinical sites ............................................ 18

9.3 Storing the device ............................................................. 18

10 Setting up the optional barcode scanner .............................................. 19

11 Turning on the device power ...................................................... 19

11.1 Connecting the device power cord .................................................. 19

11.2 Turning on the device power ...................................................... 19

12 Managing device settings ....................................................... 20

12.1 Settings screen .............................................................. 20

12.2 Setting the time .............................................................. 20

12.3 Setting the alert theme ......................................................... 21

12.4 Initial password setup .......................................................... 21

12.5 Updating or resetting the password .................................................. 22

12.6 Main screen overview .......................................................... 22

12.7 Function capabilities ........................................................... 23

13 Operating the device ........................................................... 24

13.1 Supplies required ............................................................. 24

13.2 Entering case data ............................................................ 24

13.3 Setting up the device for blood collection ............................................... 25

13.4 Setting up the wash kit .......................................................... 27

13.5 Initiating blood processing ....................................................... 29

13.6 Resuming a case ............................................................. 30

14 Managing case data ........................................................... 30

14.1 Viewing case data ............................................................ 30

14.2 Searching and filtering case data ................................................... 31

14.3 Exporting case data to a USB flash drive ............................................... 32

14.4 Exporting case data to an external device .............................................. 33

14.5 Deleting case data ............................................................ 34

15 Ending a case ............................................................... 34

16 Cleaning the device ........................................................... 34

17 Special blood processing conditions ................................................ 36

17.1 Emergency setup using multiple suction/anticoagulant lines on 1 reservoir .......................... 36

17.2 Using 2 reservoirs in series ....................................................... 37

17.3 Using 2 reservoirs in parallel ...................................................... 39

17.4 Draining cardiopulmonary bypass circuit (CPB) contents to the device ............................. 40

17.5 Postoperative wound drainage ..................................................... 40

18 Troubleshooting guide ......................................................... 40

18.1 Power failure ............................................................... 40

18.2 Unusual behavior of the device .................................................... 41

3

18.3 Normal startup prompts, audible and visual alert signals ..................................... 41

18.4 Normal operating prompts, audible and visual alert signals .................................... 42

18.5 Error prompts, audible and visual alert signals ........................................... 46

18.6 Irrecoverable errors, audible and visual alert signals ........................................ 46

19 Service and maintenance ....................................................... 47

19.1 Service interval .............................................................. 47

19.2 Pump head ................................................................ 47

19.3 Service and maintenance screens .................................................. 47

19.4 Notifications ................................................................ 48

19.5 System information ............................................................ 49

19.6 Error log .................................................................. 49

19.7 Calibrate touchscreen .......................................................... 49

19.8 Clean centrifuge ............................................................. 49

19.9 Update software ............................................................. 49

19.10 Export service information ....................................................... 49

20 Device disposal and ownership transfer .............................................. 50

20.1 Deleting case data ............................................................ 50

20.2 End of life disposition .......................................................... 50

21 Specifications ............................................................... 50

21.1 Technical specifications ......................................................... 50

21.2 Electromagnetic compatibility declaration .............................................. 50

22 Warranties ................................................................. 52

22.1 Equipment limited warranty for US customers ............................................ 52

22.2 Equipment limited warranty for customers outside the US ..................................... 53

4

1 Explanation of packaging, labeling, and device symbols

Caution

Fuse

Equipotentiality

Ground

Power

Stop

Vacuum pump power

Alternating current

Humidity limitation

Temperature limit

Consult instructions for use

Consult accompanying documents

Do not resterilize

Do not reuse

Do not use if package is damaged

Nonsterile

Catalog number

5

Lot number

Serial number

Manufacturer

Date of manufacture

Use-by date

Sterilized using ethylene oxide

Nonpyrogenic fluid path

Quantity

For US audiences only

Conformité Européenne (European Conformity). This symbol means that the
device fully complies with applicable European Union Acts.

Medical equipment with respect to electric shock, fire, and mechanical haz­ards only in accordance with ANSI/AAMI ES60601-1 (2012), CAN/CSA
C22.2 No. 60601-1 (2014) E352357.

Do not dispose of this product in the unsorted municipal waste stream. Dis­pose of this product according to local regulations. See
http://recycling.Medtronic.com for instructions on proper disposal of this
product.

This way up

Keep dry

Fragile, handle with care

Manufactured in

Corrugated recycles

6

Protective earth ground

Atmospheric pressure limitation

China RoHS standard (SJ/T11364-2006)

Contains di(2-ethylhexyl)phthalate (DEHP)

Authorized representative in the European Community

Heavy

Do not push by the IV pole

Storage temperature limit

Transit temperature limit

Storage humidity limitation

Transit humidity limitation

Storage atmospheric pressure limitation

Transit atmospheric pressure limitation

Type BF applied part

2 Introduction

Autotransfusion is a procedure in which the blood lost by, or removed from, a patient (autologous blood) is subsequently returned
to the patient.

2.1 Advantages of autotransfusion over allogeneic transfusion

There are several benefits to autotransfusion:

• The risk of blood-transmitted diseases is eliminated.

• The related costs of transfusion are minimized.

• The risk of clerical errors is minimized.

7

• The use of autologous blood provides additional assurance during surgery on patients with multiple red blood cell antibodies
or rare blood phenotypes.

• Valuable allogeneic blood is conserved.

• This process is generally accepted by patients with religious objections to allogeneic transfusion.

2.2 Principles of operation

Blood contains a suspension of formed elements of different densities. The autoLog IQ autotransfusion system (the device)
operates by separating whole blood into its individual components by centrifugation.

During operation, the following materials are recovered:

• Washed, packed red blood cells

• A small volume of saline

The following materials are less dense than red blood cells; they are removed during operation:

• Lipids and fats

• Plasma-free hemoglobin

• Pharmacologic agents

• Irrigation solutions

• Anticoagulants

• Potassium

• Plasma

• Saline

As blood continues to enter the spinning bowl, the amassing red blood cell pack begins to occupy more of the bowl volume, and the
excess plasma is pushed ahead of the red blood cells. When the total liquid volume of the bowl has been exceeded, the excess
plasma exits the bowl through the effluent outlet to the waste bag via the connecting tubing.

To rid the red blood cell pack of contaminants, it is washed with isotonic saline (0.9% sodium chloride solution).

Note: Trace amounts of red blood cell contamination may cause the effluent to have a slightly reddish tint.

After washing, the clean, packed red blood cells are pumped from the bottom of the bowl to the holding bag, via the attached tubing.
The blood should be transferred to a blood transfer bag and then to the patient.

Figure 1. Whole blood separation

8

1 Whole blood inlet
2 Effluent outlet

3 Plasma
4 Red blood cells

3 Intended use

The autoLog IQ autotransfusion system and Medtronic wash kit are intended for use in the collection, concentration, washing, and
reinfusion of autologous blood. Areas of application may include, but are not limited to, the following:

• Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and
neurological

• Postoperative treatment areas

4 Contraindications

The process of blood recovery is associated with few complications. The surgical team must consider the risks and relative
contraindications of autotransfusion in any surgical procedure before proceeding with autotransfusion.

5 Warnings and precautions

• Read this user manual before using the device.

• Do not use the device for direct patient reinfusion (from the device directly into the patient). Adequate safeguards do not exist
to protect the patient in this situation.

• Reinfusion of washed red blood cells can be carried out by gravity or pressure infusion after transferring processed blood to
blood transfer bags. Do not directly reinfuse processed blood from the holding bag to the patient. Directly reinfusing the blood
from the holding bag exposes the patient to the risk of air embolism. If a direct patient connection is required, follow the guidance
for detecting and preventing air embolism in accordance with the current version of AABB Standards for Perioperative
Autologous Blood Collection and Administration.

• Actual performance results may vary depending on many in-use variables. It is important to read and understand this user
manual and understand the principles of cell washing before using the device for clinical operation. The responsibility for the use
of this device in all cases belongs solely to the physician ordering its use.

• Failure to follow instructions may result in blood spillage, biohazard risk, slip hazard, low blood quality, infection, and hemolysis.

• Treat all blood and fluids in accordance with universal bloodborne pathogen precautions.

• AABB Standards for Perioperative Autologous Blood Collection and Administration recommends the expiration period for blood
recovered intraoperatively, processed, and stored at room temperature, be no longer than 8 hours from the completion of
processing. Intraoperative blood collected with processing can be stored for 24 hours between 1°C and 6°C (34°F and 43°F),
if the storage begins within 8 hours of completing processing. The transfusion of blood collected and processed under
postoperative or posttraumatic conditions must begin within 8 hours of initiating the collection. Refer to the current version
of AABB Standards for Perioperative Autologous Blood Collection and Administration for more information.

• Medtronic recommends the use of a blood transfusion filter, designed to retain particles that are potentially harmful to the
patient, between the reinfusion container and the patient, in accordance with the current version of AABB Standards for
Perioperative Autologous Blood Collection and Administration.

• Tandem collection reservoirs and leukocyte filtration can be used in relatively contraindicated cases; refer to the current version
of AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma for more information.

• For orthopedic cases, always agitate the reservoir before processing the first cycle.

• Do not leave the device unmonitored, as it could present a biohazard risk if the waste or holding bag overflows, or could result
in the loss of salvageable blood, among other concerns. It is the responsibility of the hospital to ensure that the individuals
assigned to operate this device are well trained in the operation of the device and alert to potential problems.

• This device is intended for autotransfusion use in clinical patient care areas such as operating rooms, intensive care, and
recovery rooms.

• Failure to use aseptic technique increases the risk of contaminating the disposables and harming the patient.

• Carefully monitor the patient’s anticoagulation status in order to prevent complications. The basic concept of cell washing
involves the removal of contaminated plasma and debris, while leaving red blood cells suspended in saline. Removal of large
amounts of plasma during autotransfusion can cause patient hypovolemia. Since platelets and coagulation factors are
contained in the plasma, this plasma removal may also reduce coagulation factors or platelet levels below normal levels. It is also
possible that inadequate washing of salvaged blood may result in insufficient removal of anticoagulant or the development of
coagulopathies upon the return of that blood to the patient.

• All autologous collected blood should be washed prior to reinfusion.

• Blood may be salvaged from body cavities, joint spaces, and other operative or trauma sites. If there is clinical evidence of
sepsis, malignancy, or wound contamination, use tandem blood collection reservoirs and leukocyte filtration in accordance with
the current version of AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma.

• Never transfuse blood that is suspected of having high hemolysis.

• Only use isotonic solutions that are labeled for intravenous use, such as 0.9% saline.

• To avoid hemolytic and subhemolytic stress and subsequent red blood cell lysis, vacuum pressure should be regulated at

−80 mmHg to −120 mmHg, which is adequate for most surgical procedures. The vacuum setting may be temporarily increased
to clear the field in the event of massive blood loss, then reduced to a lower setting; refer to the current version of AABB
Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma for more information.

• Applicable to products with phthalates identified on the product label: This product contains phthalates.

• Only use Medtronic wash kits and blood collection reservoirs with the device.

9

• The disposables are sterile and nonpyrogenic as long as package integrity has not been violated. Do not use the disposables
if the package is damaged or open. Store all disposables in a dry place away from extreme temperatures.

• The disposable components utilized with this device are single use only. Do not reuse, reprocess, or resterilize the disposable
components. Reuse, reprocessing, or resterilization may compromise the structural integrity of the disposables or create a risk
of contamination of the disposables, which could result in patient injury, illness, or death. Only Medtronic sterilized disposable
kits are approved for patient use with the device. Maintain a sterile field at the collection site. Use aseptic technique to minimize
the possibility of contamination of the disposable components or the patient.

• The disposables must be used immediately after the removal of the protective packaging. Visually inspect the disposables. If
any evidence of damage to the disposables is found during inspection or setup, do not use the disposable; return it to Medtronic
for replacement. Do not use silicone, oils, or greases near the disposables.

• Dispose of the disposables in accordance with local hospital, administrative, and other government policies.

• Inspect the device and included items for shipping damage upon unboxing them. Confirm that all items are included in the box
(Section 7.2). Contact your Medtronic service representative if damage is observed, or if an item is missing.

• Failure to fully secure connectors can lead to blood leakage.

• Close all clamps and use caution if transferring the disposables to a new device.

• The device must not be used in the presence of flammable anesthetic agents.

• Do not touch the bowl while it is spinning. Touching the moving bowl can lead to injury.

• Do not place items on the reservoir holder or collection reservoir.

• If using the rear reservoir holder, self-start will not be enabled, which could result in fluid overflowing the reservoir. Reservoir
overflow could cause blood spillage, biohazard risk, and slip hazard.

• Do not use any solutions hotter than 42°C (108°F), because high heat can result in crenation and can destroy red blood cells.

• To avoid overheating the centrifuge, which could cause hemolysis and crenation, do not use the device at temperatures higher
than 30°C (86°F).

• Do not use the device at temperatures lower than 15°C (59°F).

• Plastic materials used in the device and its disposable components may be sensitive to chemicals and certain detergents.
Under certain adverse conditions, exposure to these chemicals (including vapors) can cause the plastics to fail or malfunction.

• Power loss or other failure during the Fill and Wash cycles may result in lower than normal blood quality parameters. Test the
blood for hematocrit and contaminant removal to confirm suitability for patient infusion.

• Setting the vacuum at higher than desired settings, or unintentionally selecting Max vacuum, could result in hemolysis and
tissue damage.

• Do not restrict the flow in any tubing line. If a tubing line is inadvertently clamped or kinked during operation, pressure may build
up in the centrifuge bowl causing failure or leakage. Always examine the entire disposable kit to confirm that all tubing is free of
any kinks, twists, or flat areas. Examine the pump head and wash kit to confirm that all components are placed in the proper flow
direction.

• The standard waste bag for the device holds approximately 10 L. Check the waste bag volume periodically and empty as
required. The waste bag may be emptied at any time; however, 100 mL to 200 mL of fluid should be left in the bag to provide for
proper expansion during filling and emptying. A full waste bag will cause back pressure, which may cause bowl leaks to occur.

• The device includes a centrifuge that rotates at 10,000 rpm. Parts that turn at high speeds may be dangerous. Follow safety rules
related to the use of centrifuges. Do not open the centrifuge or remove the bowl before the centrifuge has completely stopped.

• Failure to respond to unusual behavior of the device could result in blood contamination or spillage.

• Choosing to wash a partially filled bowl may result in low blood quality and low red cell volume.

• Do not invert the bowl when examining for clots, as this could lead to fluid leakage.

• Do not service the device or update the device’s software during use.

• Do not move the device by holding the IV pole, as this action could damage the device or cause tipping.

• Use caution when transporting the device by vehicle. Do not expose the device to extremes of temperature, shock, or vibration.

• Do not modify the device.

• Contact your Medtronic service representative, or a biomedical equipment technician trained and certified by Medtronic, to
perform preventative maintenance and calibration of the device. Preventative maintenance and calibration should be performed
on an annual basis. Blood spillage, biohazard risk, low blood quality, slip hazard, and other concerns, could result if preventative
maintenance and calibration are not performed.

• Always turn off and unplug the device prior to working inside the cabinet or changing any fuses. Inside the cabinet are various
electrical components and wiring. Physical contact with any of these components while the device is plugged in could result in
severe electrical shock. For continued protection against risk of fire, replace fuses only with the same type and rating. Fuses
should be replaced by a Medtronic service representative or Medtronic-trained and certified biomedical equipment technician.
Internal grounding is provided for safety.

• Enclosure current leakage is a primary indicator of electrical shock hazard to personnel making contact with any exposed
portion of the equipment. Each device is tested during the final quality inspection to verify enclosure current leakage is less than
100 µA (under normal operating conditions) and less than 300 µA (under single-fault conditions). Ensure that the current
leakage is tested at least once a year, or more frequently as required, by the operating facility’s biomedical engineering
department or other qualified service technician. In addition, always test the enclosure current leakage and insulation after an
event such as a fluid spill, after a major voltage surge in the power source has occurred, or after any device repair.

• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with a protective earth ground.

• The power cord may be used to disconnect the device from electrical power. Position the device and power cord so that the
power cord can easily be accessed and disconnected.

• Although this device has been verified for EMC compliance, the potential exists that, in some situations, this device and other
devices might electromagnetically interfere with each other. Take steps to minimize this possibility.

10

• The device should only be used in a hospital environment away from sources of high intensity EM disturbances, such as MRI
devices.

• The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate
protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or
reorienting the device.

• Do not stack or attach additional instrumentation to the device to minimize the potential for RF interference.

• Use of this device with accessories, transducers, and cables other than those specified or provided by the manufacturer of this
device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in
improper operation.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 in) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this device could result.

• Power cord and USB cable length must not exceed 3 m (118 in).

• Do not touch a USB port and the patient at the same time.

• Use only a USB flash drive provided by Medtronic.

• Use appropriate personal protective equipment such as eye protection, mask, and gloves when cleaning the device and
discarding used fluids. Failure to do so could result in exposure to bloodborne pathogens, blood, and cleaning fluids.

• While cleaning the centrifuge, failure to correctly install the tray for fluid collection will lead to spillage.

• While cleaning the centrifuge, failure to add sufficient volume of a 10% bleach solution or equivalent disinfectant solution for a
sufficient duration can lead to ineffective cleaning.

• Do not use bleach to clean the touchscreen, as this could discolor the screen and result in failure.

• If it is suspected that fluid has entered the device, it should be immediately examined by a trained technician. Fluid ingress could
result in electric shock to the user.

• Clean and maintain the device in accordance with this manual and hospital procedures.

6 Adverse effects

Proper or improper use of a cell salvage device can lead to the following risks to the patient and user:

Patient:

• Death

• Excessive bleeding

• Hemolysis

• Impaired liver function

• Loss of salvageable blood

• Infection

• Renal insufficiency and failure

• Low hematocrit

• Elevated serum lactate dehydrogenase levels

• Elevated total serum bilirubin levels

• Air emboli

• Febrile reaction

• Hypotension

• Increase in pulmonary and systemic vascular resistance

• Dyspnea

• Increased clotting

• Thromboembolism

• Tissue damage

• Arrhythmia

• Micro-shock

User:

• Exposure to biological fluids

• Biohazard

• Chemical exposure

• Burn injury

• Mechanical injury

• Electrical shock

• Slipping

7 Device description

7.1 Device components

The following figures detail the components of the device:

11

Figure 2. Device controls

1 Power: Turns the device power on and off
2 Power LED: Illuminates when the device power is on
3 Vacuum: Turns the device’s internal vacuum on and off
4 Vacuum LED: Illuminates when the device’s internal vacuum is on
5 Stop: Stops the blood processing sequence and returns blood to the reservoir
6 Alert light: Illuminates when a prompt is displayed on the touchscreen (for more information regarding visual alert signals, see

Section 7.5)

Figure 3. Top panel

1 Centrifuge chamber (level sensor not shown)
2 IV pole collar
3 IV pole knob
4 Centrifuge notches
5 Touchscreen
6 Removable storage tray

7 Pump lever
8 Pump outlet tubing guide

9 Pump head
10 Pump tubing channel
11 Manifold cover latch
12 Manifold cover

12

Figure 4. Top panel with manifold cover open

1 Air detector
2 Tubing guides
3 Manifold valve

Figure 5. Front panel

4 Manifold cover locking sensor

5 Manifold sensor

6 Recessed cavity

1 Reservoir weight sensor (enables self-start mode)
2 Reservoir holder
3 IV pole
4 Wash kit cradle arm

5 Speaker (under top panel)

6 Internal storage compartment

7 Device base

13

Note: The internal storage compartment can be used to store additional disposables and solutions as needed. Use caution when
opening and closing the compartment, and while moving items to and from the compartment.

Figure 6. Back panel

1 Manifold valve cavity fluid drain
2 Vacuum overflow trap quick-disconnect
3 Vacuum overflow trap
4 Wash kit storage brackets
5 Power cord wrap
6 Wheel lock (4)

7 Equipotential connector

8 Power inlet module

9 Power cord retainer clip
10 Locking wheels (4)
11 Rear reservoir holder mounting base
12 Handle

14

Figure 7. Handle positions

1 Upper storage position
2 Push position

3 Handle release button

4 Lower storage position

Note: Push the handle release button to move the handle into each position.

15

Figure 8. Left panel

1 Accessory USB ports (type A)
2 Barcode scanner holster (optional)

Figure 9. Right panel

3 Barcode scanner cord retainer clip

4 Barcode scanner (optional)

16

1 Waste bag pins
2 Wash kit storage holders

Figure 10. Bottom panel

3 USB port (type B)

4 Accessory USB port (type A)

1 Wash kit tray holder
2 Centrifuge drain (1/4-18 NPT)

3 Fan

4 Vacuum pump outlet

7.2 Items included with the device

The following items are included with the device:

• IV pole

• Reservoir holder

• Quick setup guide

• Quick setup video

• User manual

• Power cord

• USB flash drive

7.3 Optional items not included with the device

The following items are sold separately:

• Barcode scanner (used to simplify data entry; Chapter 10)

• Reservoir holder (attaches to the device rear reservoir holder mounting base; Figure 6)

• Medtronic cardiotomy reservoir holder E302 (attaches to an external IV pole)
Warning: Do not attach a reservoir to the device IV pole using a reservoir holder such as the Medtronic E302. The weight of a

filled reservoir attached to the device IV pole may cause tipping.

7.4 Audible alert signals

The device emits an audible alert signal when a prompt appears on the touchscreen. Audible alert signals are divided into 3
categories: notify alert, low alert, and medium alert; all require a response. See Section 13.4, Chapter 18, and Section 19.4 for the
full list of prompts and corresponding audible alert signals.

• Notify alert: 2 beeps

• Low alert: 2 beeps, repeating

• Medium alert: 3 beeps, repeating

To adjust and test the audible alert signal volume level, go to the Settings screen, and press

or in the Volume field.

7.5 Visual alert signals

The alert light (Figure 2) on the device illuminates to indicate that there are prompts that may require a response. Visual alert signals
are divided into 2 categories: low alert and medium alert. The visual alert signal categories align with the audible signal categories.
See Section 13.4, Chapter 18, and Section 19.4 for the full list of prompts and corresponding visual alert signals.

• Low alert: alert light is illuminated, and not flashing

• Medium alert: alert light is flashing

17

8 In vitro performance

65

10*

20**

30*

0

10

20

30

40

50

60

70

64

59

Figure 11. Typical hematocrit

1 Inlet hematocrit (Hct %)
2 Achievable hematocrit, mean (Hct %)

The data in Figure 11 are from in vitro testing using human blood and standard wash protocol. Clinical results may vary.

9 Transportation and storage

9.1 Transporting the device

Warning: Failure to adhere to the following loading conditions when transporting the device may lead to tipping:

• When using the bottom IV pole hooks, do not attach more than 5 L of liquid, and do not attach any bag higher than 48.3 cm (19 in)
above the device.

• When using the top IV pole hooks, do not attach more than 3 L of liquid, and do not attach any bag higher than 86.4 cm (34 in)
above the device.

• Do not attach a collection reservoir.

• Do not attach a waste bag.

Caution: Do not move the device by holding the IV pole, as this action could damage the device or cause tipping.

• Unplug the device power cord before transporting the device.

• Do not drop the device.

• Do not push, tip, or lean on the IV pole.

• If the device is tipped over or dropped, ensure that a trained service technician examines the device before use.

• Unlock the wheels if necessary.

• Only move the device while holding the handle. Rotate the handle to the push position (Figure 7).

• Use caution when transporting the device when fluids are present.

• See Chapter 21 for transit and storage environmental limits.

9.2 Transporting the device between clinical sites

• The device stores data after a password is set. Refer to institutional policies regarding the handling of protected health
information and data security before transporting the device to another clinical site.

• Before moving the device, retract the IV pole and secure it by tightening the IV pole knobs.

• Lock the wheels before lifting the device into a vehicle.

• If it is necessary to lift the device, it should be done by a minimum of 2 people. Lift the device by holding it at the device base
(Figure 5) or the power cord wrap (Figure 6). Do not lift the device by holding any other points. Use caution when lifting the
device.

• The device may be transported without its original packaging, either standing upright or lying on its back.
Warning: Use caution when transporting the device by vehicle. Do not expose the device to extremes of temperature, shock,

or vibration.

9.3 Storing the device

• Store the device according to the environmental conditions specified in Chapter 21.

• When not in use, turn off the device power and disconnect the power cord from the supply mains. Store the power cord by
wrapping it around the power cord wrap on the back of the device (Figure 6).

• Store the device in a cool, dry, and well-ventilated area.

18

• Refer to institutional policies regarding the handling of protected health information and data security before storing the device.

• Store the USB flash drive in a secure location.

10 Setting up the optional barcode scanner

The barcode scanner (sold separately) can be used to enter the following information into the device:

• Patient and operator IDs

• Blood collection and processing disposables lot data

• Heparin lot data

• ACD-A lot data

To set up the barcode scanner, perform the following steps:

1. To install the holster, use the tool included in the barcode scanner kit to remove the screw from the left side of the device
(Figure 8).

2. Attach the holster to the left side of the device, and then reinstall the screw using the tool.

3. Place the scanner in the holster, in an upright position.

4. Connect the scanner cord to a USB port (type A). See Figure 8.

5. Secure the cord using the barcode scanner cord retainer clip.

6. To scan data into the device, see Section 13.2.

11 Turning on the device power

11.1 Connecting the device power cord

1. Remove the power cord retainer clip (Figure 6) using the thumbscrew (Figure 12).

2. Insert the connector end of the power cord into the device power inlet module, and then insert the cord into the retainer clip.

3. Reinstall the power cord retainer clip using the thumbscrew.

Figure 12. Installing the power cord retainer clip and power cord

Warning: The power cord may be used to disconnect the device from electrical power. Position the device and power cord so

that the power cord can easily be accessed and disconnected.

4. Insert the plug end of the power cord into a grounded, hospital-grade supply mains.

11.2 Turning on the device power

1. Press to turn on the device. The power LED illuminates, the alert light flashes, and the speaker emits 2 beeps.
Note: Press

the Settings screen (Figure 14). Figure 13. Turning on the power to the device

2. If turning on power for the first time, select the desired language.

3. Set the password if desired.

to activate the vacuum at the default setting, during startup. The default vacuum setting can be changed using

19

Note: A password must be set in order to store and access case data.

12 Managing device settings

12.1 Settings screen

Press Settings to access device setup, security, and user interface options.

Figure 14. Settings screen

1 Choose the device interface language
2 Set and update the password (required for storing and accessing case data)
3 Set the device name
4 Enable an audible click every time the screen is touched (a check mark appears when selected)
5 Enable a visual indicator every time the screen is touched (a check mark appears when selected)
6 Set the current time and the local time zone
7 Set the current date
8 Set the audible alert pattern

9 Adjust the audible alert volume
10 Adjust the touchscreen brightness
11 Adjust the default vacuum setting
12 Set the default maximum vacuum setting

Note: The factory default vacuum setting is -120 mmHg.

12.2 Setting the time

1. Select Time to display the time menu.

2. Select your Time zone.

3. Set the Hours and Minutes.

4. Select the desired Time format.

5. Select Daylight savings if applicable. A check mark appears when selected. Figure 15. Setting the time screen

20

12.3 Setting the alert theme

1. Select Alert theme to display the alert theme menu.

2. Select Theme One, Theme Two, or Theme Three.

3. To sample each alert, press next to the desired alert. Press to stop the alert.

4. Adjust the audible signal volume as needed using the Volume field.

Figure 16. Setting the alert theme screen

12.4 Initial password setup

A password must be set in order to store and access case data.

The device stores data for up to 100 cases. For more information, see Chapter 14.

Refer to institutional policies regarding the handling of protected health information and data security.

1. Press Set in the Password field.

2. Correctly enter the password twice in the designated text fields, using the keyboard. Passwords must contain at least 6
characters.

3. Press

.

Figure 17. Password entry keyboard screen

1 Capitalization lock
2 Dismiss keyboard
3 Number, punctuation mark, and other character access
4 Delete

4. Press Set.

5 Symbol, punctuation mark, and other character access
6 Enter; changes from gray to green when password is

entered

21

Figure 18. New password entry screen

12.5 Updating or resetting the password

1. Press Update in the Password field.

2. If the old password is known, enter it in the Old password text field.
Note: If the password is lost or forgotten, a new password can be created; however, all records protected under the old

password will be permanently deleted. Press Delete to delete the password, and then follow the instructions on the screen.

3. Correctly enter the password twice in the designated text fields, using the keyboard. Passwords must contain at least 6
characters.

4. Press

5. Press Update.

.

Figure 19. Updating or deleting the password screen

12.6 Main screen overview

The Main screen is divided into 4 areas: current case data, screen selection, user controls, and prompts.

Figure 20. Main screen

22

1 Current case data area
2 Screen selection area

Current case data area

• Fill: The volume of blood transferred from the collection reservoir to the centrifuge bowl in the current processing cycle

• Wash: The volume of saline used for the current processing cycle

• Empty: The volume of washed red blood cells transferred to the holding bag in the current processing cycle

• Bowl (X): The number of completed Fill, Wash, and Empty processing cycles

• Total: The total Fill, Wash, and Empty volumes for a case

Screen selection area

• Main: Contains current case data, user controls, and prompts

• Data: Allows the user access to data stored in the device (Chapter 14)

• Settings: Allows the user to adjust the device settings (Chapter 12)

•

: Allows the user to enter patient ID, operator ID, and disposable lot, heparin lot, and ACD-A lot data (Section 13.2)

• : Allows the user to access the Service and maintenance screen (Section 19.3)
Note: When

Section 19.4.

User controls area

• Vacuum: Allows the user to set the vacuum setting. The vacuum setting can also be adjusted during a case. The default and
maximum vacuum settings can be preset using the Settings screen (Section 12.1).

• Wash volume: The default wash volume is 250 mL. The wash volume can also be adjusted during a case; adjustments are
effective immediately. If another volume is desired, select Fast or Emergency from the Wash volume menu on the Main
screen. Fast uses 100 mL of wash solution. Emergency does not use any wash solution.

Note: Selecting Emergency causes a notification to appear every 10 min. If the notification is postponed, the notification will
reappear at the interval selected in the Reset alert field. See Section 19.4.

: Allows the user to begin or resume automated blood processing, and to control the manual FCT functions. changes to

•
during operation; press to pause the applicable operation.

Note: If the centrifuge is operating when is pressed, the paused state persists for a maximum of 60 s. After 60 s, the device
automatically returns the bowl contents to the reservoir.

• Function: Allows the user to manually transfer volumes or remove air from the holding bag (Figure 21).

: Allows the user to mute and unmute the audible signals. When muted, the button icon changes, providing a visual indication

•
of the selection.

Note: The device automatically reverts to the unmuted state after 60 s.

• Date & Time: Displays the local date and time. The flashing : indicates that the user interface is operating normally.

Note: The date and time can be adjusted on the Settings screen (Chapter 12).

Prompts area

The Prompts area presents prompts and notifications. Prompts are messages that require user action. Notifications provide
information about device conditions that are important but do not stop device operation. See Section 18.4 and Section 19.4 for
prompts and notifications that may appear during operation.

is highlighted in yellow, it indicates the presence of a notification. Click to view the notification. See

3 User controls area
4 Prompts area

12.7 Function capabilities

Note: Function capabilities are only enabled when the device is in Stop mode.

1. Press

while the pump is running, to empty the bowl to the reservoir. Wait for the bowl to empty completely, or press again

to immediately enable all Function capabilities.

23

2. Press FCT to allow for the manual transfer of volumes or to remove air from the holding bag. Choose from the 3 options shown in
Figure 21.

Figure 21. FCT capabilities screen

1 FCT 1: Empty the bowl to the reservoir. Allows for the manual transfer of blood to the reservoir.
2 FCT 2: Empty the bowl to the holding bag. Allows for the manual transfer of blood to the holding bag.
3 FCT 3: Invert the holding bag. Allows for the manual removal of air from the holding bag.

3. Press and hold to perform the selected Function.
Warning: Failure to press and hold

4. Press at any time to return to the Main screen.

when inverting the holding bag can result in air not being removed from the bag.

13 Operating the device

13.1 Supplies required

Warning: Only use Medtronic wash kits and blood collection reservoirs with the device.

Note: The Medtronic disposables are sterilized using ethylene oxide.

The following supplies are required:

• Medtronic wash kit that includes the following:
– Centrifuge bowl (135 mL capacity) with tubing
– Holding bag (1000 mL capacity)
– Waste bag (10 L capacity)

• Medtronic blood collection reservoir (4 L capacity)

• Adequate quantity of 0.9% isotonic saline for washing

• Adequate quantity of anticoagulant solution

• Blood transfer bags

• Suction/anticoagulant line

13.2 Entering case data

1. Press Figure 22. Case data entry screen

2. Press the text field corresponding to the type of data being entered.

3. To manually enter data, use the keyboard to enter the data into the selected text field.

.

24

Note: If using multiple disposables for a case, record the additional data in the Notes text field using the barcode scanner or
keyboard.

4. Press on the keyboard to enter the data in the device.

5. To scan data into the device using the optional barcode scanner (Chapter 10), press on the screen.

6. Press the text field corresponding to the type of data being scanned.

7. To use the scanner, aim it at a barcode. Ensure that the red scanner line fully covers the barcode, and then press the trigger.
Note: The scanner can read the following barcode formats, at a minimum: aztec, code 128, code 39, data matrix ECC 200, and

PDF 417.
Note: The scanner cannot read custom barcode formats.

8. After a successful scan, the scanner beeps, and the green LED illuminates. If unsuccessful, the red LED illuminates.

9. Press

10. If desired, press Main to return to the Main screen.

on the screen to record the scanned data in the device.

Note: For additional barcode scanner information, refer to the literature included with the scanner.

13.3 Setting up the device for blood collection

Figure 23. Device components

1 Anticoagulant solution
2 Saline bag (1 or more)
3 Holding bag
4 Manifold (3-way tubing assembly)
5 Line to holding bag
6 Line from saline bag
7 Line from blood collection reservoir

Warning: Failure to adhere to the following loading conditions when using the device may lead to tipping:

• When using the bottom IV pole hooks, do not attach more than 6 L of fluid, and do not attach any bag higher than 48.3 cm (19 in)
above the device.

• When using the top IV pole hooks, do not attach more than 3 L of fluid, and do not attach any bag higher than 86.4 cm (34 in)
above the device.

• 2 collection reservoirs may be filled with no more than 4 L of fluid in each.

• 1 waste bag may be filled with no more than 7 L of fluid.

8 Step-down connector

9 Suction/anticoagulant line to patient
10 Blood collection reservoir
11 Vacuum line to the vacuum overflow trap of the device or to

external regulated vacuum source

12 Waste bag

25

Note: If the device must be moved, different loading conditions apply (Section 9.1).

Warning: Failure to use aseptic technique increases the risk of contaminating the disposables and harming the patient.

Warning: Do not touch a USB port and the patient at the same time.

Warning: Failure to follow instructions may result in blood spillage, biohazard risk, slip hazard, low blood quality, infection, and

hemolysis.

Warning: Do not use any solutions hotter than 42°C (108°F), because high heat can result in crenation and can destroy red blood
cells.

Warning: Failure to fully secure connectors can lead to blood leakage.

Warning: Treat all blood and fluids in accordance with universal bloodborne pathogen precautions.

Caution: Do not touch the bowl while it is spinning. Touching the moving bowl can lead to injury.

Note: If using tandem or parallel collection reservoirs, see Chapter 17.

Note: It is not necessary to turn on the device power in order to set up the disposables.

1. Position the device on a level surface.

2. Examine the device for damage and cleanliness, and clean it if necessary (Chapter 16).

3. Lock the wheels.

4. Position the IV pole, and then tighten the IV pole knobs. Ensure that the maximum height indicator on the lower half of the IV
pole is aligned with the top of the IV pole collar. See Figure 24. Do not extend the IV pole beyond the maximum height indicator.

Figure 24. IV pole maximum height indicator

5. Attach the reservoir holder to the reservoir weight sensor or rear reservoir holder mounting base.
Warning: If using the rear reservoir holder, self-start will not be enabled, which could result in fluid overflowing the reservoir.

Reservoir overflow could cause blood spillage, biohazard risk, and slip hazard.
Caution: Do not place items on the reservoir holder or collection reservoir.

6. Remove the step-down connector from the collection reservoir.

7. Attach the step-down connector to the bottom of the collection reservoir. Ensure that the connector is fully secured.

8. Close the clamp on the step-down connector before the kit setup is complete. Ensure that the clamp is fully closed.

9. Place the collection reservoir into the reservoir holder.

10. Attach a vacuum line to the yellow-capped port on the collection reservoir.

11. Attach the other end of the vacuum line to the vacuum overflow trap of the device.
Note: The vacuum line also can be connected to an external regulated vacuum source, if necessary.

12. Aseptically pass the suction/anticoagulant line into the sterile field.

13. Attach the blue-capped suction/anticoagulant line connector to either the blue-capped or white-capped inlet port on the top of
the collection reservoir.

14. Close the roller clamp on the suction/anticoagulant line. Spike the anticoagulant container. If the container is nonvented, open
the vent cover on the drip chamber.

15. If it has not already been done, turn on the device power by pressing

.
Note: The vacuum can be enabled immediately after turning on the device power, and can be adjusted on the Main screen.
If the device power is turned on within 6 hours of previous shutdown or power loss, the message Resume previous case? If

Yes, bowl contents will be pumped to reservoir. Make sure the reservoir is connected. appears.

• To continue the previous case, select Yes. The bowl contents will be pumped to reservoir. Make sure the reservoir is
connected.

• To start a new case, select No.

Note: The device defaults to a new case if the device power is turned on 6 or more hours after shutdown or power loss. See
Section 13.6 for more information.

16. Turn on the vacuum by pressing

.

26

17. If necessary, adjust the vacuum setting using the Vacuum drop-down menu on the Main screen. The vacuum setting can be
increased or decreased manually using and , or it can be set to the preprogrammed Default or Max vacuum settings. See
Section 12.1 to set the Default and Max vacuum settings.

Warning: Setting the vacuum at higher than desired settings, or unintentionally selecting Max vacuum, could result in
hemolysis and tissue damage.

Note: The factory default vacuum setting is −120 mmHg.
Note: After selecting Max vacuum, the message Confirm max vacuum? appears. Select Yes to confirm or No to decline.
Note: Selecting Max vacuum causes a notification to appear every 10 min. If the notification is postponed, the notification will

reappear at the interval selected in the Reset alert field.
Figure 25. Vacuum settings screen

18. Before blood collection, open the roller clamp and prime the collection reservoir with a minimum of 200 mL of anticoagulant
solution.

19. Reduce the anticoagulant flow to a ratio of approximately 15 mL of solution to 100 mL of blood.

20. Monitor the collection reservoir periodically for appropriate anticoagulation.

21. Prime the collection reservoir with anticoagulant solution each time the collection reservoir is emptied.

13.4 Setting up the wash kit

See Table 1 for prompts associated with the setup of the disposables.

1. Attach the saline wash solution containers to a lower IV pole hook.

2. Rotate the blue wash kit cradle arm as shown in Figure 26.

3. Place the wash kit in the cradle arm and remove the wash kit cover. Figure 26. Wash kit cradle arm

4. To enter the patient and operator IDs, and the disposable lot, heparin lot, and ACD-A lot data into the device, see Section 13.2.

5. Remove the waste bag from the wash kit.

6. Confirm that the drain valve is closed on the waste bag.
Warning: Failure to close the drain valve can lead to blood leakage.

7. Install the waste bag onto the waste bag pins on the right-facing side of the device. Ensure that the waste bag volume label faces
away from the device.

8. Remove the holding bag from the wash kit and hang it on an upper IV pole hook. Close the clamps on the 2 red-capped outlet
lines that each include a membrane port.

9. Place the bowl in the centrifuge chamber with the yellow-capped waste line outlet tubing facing the waste bag. Refer to the
markings on the top panel.

10. Align the centrifuge markings with the vertical assemblies on the bowl.

11. To lock the bowl, simultaneously press down on the bowl and turn it clockwise until a click is heard.

12. Insert the yellow-capped connector into the yellow-capped inlet port on the waste bag.

27

13. Confirm that there are no kinks in the waste line.
Note: If desired, the wash kit tray may be removed and the cradle arm rotated to its original position.

14. Open the manifold cover.
Note: See the top panel components in Figure 3 and Figure 4.

15. Place the manifold into the recessed cavity.

16. Place the 3 manifold tubing lines into the tubing guides, and ensure that each tube is fully seated in each guide.

17. Place the single tubing line of the manifold into the air detector, and ensure that it is fully seated.

18. Close the manifold cover.
Note: There is a feature on the manifold cover that pushes the tubing into the air detector when closing the cover.

19. Rotate the manifold cover latch until the lock indicators are aligned.

20. Pull the pump lever and hold it open.

21. Stretch the pump tubing around the pump head and over the pump outlet tubing guide. Release the pump lever.

22. Close the saline line clamps.

23. Spike the middle manifold tubing into the saline bag or bags.
Note: If using only 1 saline bag, confirm that the clamp on the unused saline line is closed.

24. Open the saline clamp or clamps.

25. Connect the left-hand tube of the manifold to the blue-capped step-down connector at the bottom of the reservoir, and then
open the clamp on the step-down connector.

26. Respond to prompts on the touchscreen.

Table 1. Setup of disposables prompts, audible alert signals, and visual alert signals

Prompt Response

Kit is not installed. Lock the bowl
cover.

The sensor has detected that the bowl cover is not
locked.

Audible alert
signal

None None

Visual alert
signal

1. Place the bowl in the centrifuge chamber with the
yellow-capped waste line outlet tubing facing the
waste bag. Refer to the markings on the top
panel.

2. Align the centrifuge markings with the vertical
assemblies on the bowl.

3. To lock the bowl, simultaneously press down on
the bowl and turn it clockwise until a click is heard.

Insert the kit in the valve and the pump.
Press to resume.

a

The kit is not properly installed in either the manifold
valve or the pump.

None

None

1. Open the manifold cover.

2. Place the manifold into the recessed cavity.

3. Place the 3 manifold tubing lines into the tubing
guides, and ensure that each tube is fully seated
in each guide.

4. Place the single tubing line of the manifold into
the air detector, and ensure that it is fully seated.

5. Close the manifold cover.
Note: There is a feature on the manifold cover

that pushes the tubing into the air detector when
closing the cover.

6. Rotate the manifold cover latch until the lock indi­cators are aligned.

7. Pull the pump lever and hold it open.

8. Stretch the pump tubing around the pump head
and over the pump outlet tubing guide.

9. Release the pump lever.

Kit is not installed. Lock the manifold
cover. Press to resume.

a

A sensor has detected that the manifold cover is not
locked.

None None

1. Open the manifold cover.

2. Place the manifold into the recessed cavity.

3. Place the 3 manifold tubing lines into the tubing
guides, and ensure that each tube is fully seated
in each guide.

4. Place the single tubing line of the manifold into
the air detector, and ensure that it is fully seated.

5. Close the manifold cover.

28

Table 1. Setup of disposables prompts, audible alert signals, and visual alert signals (continued)

Audible alert

Prompt Response

signal

Note: There is a feature on the manifold cover

that pushes the tubing into the air detector when
closing the cover.

6. Rotate the manifold cover latch until the lock indi­cators are aligned.

Connect the saline line and reservoir.
Press to resume.

1. Spike the middle manifold tubing into the saline
bag or bags.

None None

Note: If using only 1 saline bag, confirm that the
clamp on the unused line is closed.

2. Open the saline clamp or clamps.

3. Connect the left-hand tube of the manifold to the
blue-capped step-down connector at the bottom
of the reservoir, and then open the clamp on the
step-down connector.

4. Press

Air in saline line. Press to resume. If the device detects air during the prime or wash pha-

.

Low

ses, this message appears.

1. Confirm that the saline bags are mounted and
spiked. Mount and spike the saline bags if nec­essary.

2. If the previous step does not resolve the mes­sage, reset the alert multiple times.

3. If previous steps do not resolve the message,
ensure that the tubing is correctly inserted into the
air detector.

4. If the previous steps do not resolve the message,
clean the air detector and tubing with water, and
then dry.

5. If the previous steps do not resolve the message,
use a different device if available. Contact your
Medtronic service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Failed to move the valve. Check the kit
installation. Press to resume.

1. Open the manifold cover.

2. Place the manifold into the recessed cavity.

Medium Medium

3. Place the 3 manifold tubing lines into the tubing
guides, and ensure that each tube is fully seated
in each guide.

4. Place the single tubing line of the manifold into
the air detector, and ensure that it is fully seated.

Note: There is a feature on the manifold cover
that pushes the tubing into the air detector when
closing the cover.

5. Close the manifold cover.

6. Rotate the manifold cover latch until the lock indi­cators are aligned.

7. Press

a

Prompt will have different audible and visual alert signals when issued during operation.

.

Visual alert
signal

Low

13.5 Initiating blood processing

13.5.1 Blood processing

Warning: Do not apply pressure to the holding bag, as this can lead to air embolism.

Note: Respond to prompts that appear during operation. See Section 18.4 and Section 19.4 for a list of prompts that may appear

during operation.

1. The message Machine stopped. Press to enable self-start. appears.

2. Press to activate the self-start mode. The message Self-start enabled. Press to manually start. appears.
Note: The device automatically starts when it detects approximately 800 mL of blood in the reservoir for at least 5 s.

3. If it is desired to begin the fill before 800 mL is collected, press .

4. The default wash volume is 250 mL. The wash volume level can be adjusted during a case; adjustments are effective
immediately. If a different wash volume is desired, select one from the Wash volume menu on the Main screen.

29

Figure 27. Wash volume screen

13.5.2 Pausing and stopping blood processing

If necessary to pause a Fill, Wash, or Empty phase, press . During the Fill and Wash phases, the centrifuge continues to spin,
and the pump pauses for 60 s. Press
selected within 60 s.

If necessary to stop a Fill, Wash, or Empty phase, press . This automatically returns the bowl contents to the reservoir.

Note: Function capabilities are only enabled when the device is in Stop mode.

13.5.3 Blood transfer

1. If necessary, empty the holding bag line by pressing FCT 2. The following prompt appears: FCT 2: Empty the bowl to the
holding bag. Press and hold

2. Transfer blood from the holding bag to a transfer bag, transfer blood in the holding bag, or transfer blood by direct patient
connection.

Warning: If a direct patient connection to the processing device is required, take additional measures to detect and prevent air
embolism (refer to the current version of AABB Standards for Perioperative Autologous Blood Collection and Administration).

Note: If using a transfer bag, remove all air from the transfer bag line by squeezing the transfer bag, before transferring it to the
anesthesiologist.

Note: If using the holding bag to transfer blood, use FCT 3 to remove air from the bag, before transferring it to the
anesthesiologist.

3. Place a new holding bag on the IV pole and connect it to the device if applicable.

4. Press

to continue.

to resume. The device times-out and returns the bowl contents to the reservoir if is not

to run the pump. Press when complete. (Section 12.7).

13.6 Resuming a case

If the device power has been turned off during a case, resume the case by restarting the device within 6 hours. To resume a case,
perform the following steps:

1. Press to turn on the device. The power LED illuminates, the alert light flashes, and the speaker emits 2 beeps.

2. The following message appears: Resume previous case? If Yes, bowl contents will be pumped to reservoir. Make sure

the reservoir is connected. To resume the previous case, select Yes.
Note: The device defaults to a new case if the device power is turned on 6 or more hours after shutdown or power loss.

14 Managing case data

A password must be set in order to store and access case data.

The device stores data for up to 100 cases. A notice appears when 90 cases have been stored, to inform the user that the storage
is nearly full. If additional case data is stored after the limit of 100 cases has been met, 1 old case will be deleted for each new case
added.

Refer to institutional policies regarding the handling of protected health information and data security.

14.1 Viewing case data

1. To view current case data, press Data.
Note: To view all case data, press Login, enter the password, and press
Note: After the password has been entered, cases appear chronologically, with the most recent case on top. A scroll bar

appears if more than 6 cases are displayed.

2. To filter the data, see Section 14.2.

3. Select the desired cases by pressing anywhere in the applicable rows.
Note: Press Select all to see data for all stored cases. Press Select none to undo this.

. If a password has not been set, see Section 12.4.

30

4. Press Details. Figure 28. Case list screen (password entered)

5. Case date, bowls, and data entered by the user appear. Press to view bowl data for the case. Figure 29. Case date, bowls, and data entered by user screen

6. The volumes for each bowl appear. Press Start times to display the Fill, Wash, and Empty start times of each bowl. Press
Volumes to return to the bowl volume data screen.

7. Press

8. Press Previous to access the previous case record.

9. Press Next to access the next case record.

10. Press Back or Data to return to the case list screen.

Figure 30. Bowl volume data screen

to return to the case date, bowls, and data entered by user screen.

14.2 Searching and filtering case data

1. From the case list screen, press Filter to narrow results.

31

2. To filter by date, press anywhere in Oldest case or Newest case. Figure 31. Data filter screen

3. Change the date as desired. Press to close the menu.

4. For all other text fields, enter text by pressing the text field and using the keyboard. Clear the text fields by pressing .

5. Press Back to apply the filter.

6. To clear the filter and return to the case list screen, press

.

14.3 Exporting case data to a USB flash drive

14.3.1 Exporting case data

Caution: Use only a USB flash drive provided by Medtronic.

1. Plug a USB flash drive into one of the accessory USB ports (type A). See Figure 8 and Figure 9 for the location of the USB ports.

2. From the case list screen, select the desired cases and press Download to USB.
Note: If the USB flash drive was not installed, or was improperly installed, the message Download failed. appears. Properly

install a USB drive and press Download to USB.

3. After download, select Yes to delete the downloaded cases from the device. Select No to keep the downloaded cases stored
in the device.

4. Remove the USB flash drive.

Figure 32. Download is complete screen

14.3.2 Viewing exported case data

Exported case data is saved on the USB flash drive in a standard comma-separated values (CSV) text file, which can be opened
and viewed in most spreadsheet software applications. To view exported case data, browse to the file location on the USB flash drive
containing the file, and then open the file using a spreadsheet software application. The case data will appear in a tabular format
(Figure 33), with the following headings:

• Print Date

• Device SN

• System name

• Case Date

• Patient ID

• Operator ID

• Reservoir Lot #

• Wash Kit Lot #

32

• Suction Line Lot #

Print Date Device SN

System
name

Reservoir
Lot #

Wash Kit
Lot #

Suction
Line Lot #

Heparin Lot #

ACD-A Lot #

Case Date

Patient ID

Operator ID

Bowl #

Total

End of data

Fill (mL.) Fill start time Wash (mL.) Wash start

time

Empty
(mL.)

Empty start
time

Incomplete
Fill?

13-Oct-16

20-Jan-16

ATLGIQ

No

No

No

2

1

3

535

520

552

11:00

9:00

11:15

11:01

9:01

11:16

11:03

9:03

11:18

1607

250

250

250

750

135

90

100

325

223456789123456789

116909914

75881868

4456789

10233729 5567891

Notes

Ortho case.

• Heparin Lot #

• ACD-A Lot #

• Notes

• Bowl #

• Fill (mL)

• Fill start time

• Wash (mL)

• Wash start time

• Empty (mL)

• Empty start time

• Incomplete Fill?

• Total

• End of data

Figure 33. Case data file (example only)

14.4 Exporting case data to an external device

Case data can be exported to an external device that has been configured with software that supports device case data exports.
Contact your Medtronic service representative for support.

Note: When the device is connected to an external device, it is more susceptible to electrostatic discharge, which may result in the
interruption of data export. Data export may be restarted if interrupted.

1. Connect a USB cable (type A male to type B male) from the type B USB port on the device (Figure 9) to a type A port on the
external device.

Warning: USB cable length must not exceed 3 m (118 in).
Note: Ensure that any PC, external device, or external information technology equipment connected to the type B USB port on

the device is certified equipment that complies with IEC 60950-1.

2. From the case list screen, select the desired cases and press

.

3. The message Selected cases received? appears.

• Select Yes if the data was successfully received.

• Select No if the export was not received completely. The message Reset the connection and try again. appears. Select
OK. The message Download failed appears. Select OK. To retry the export, check the USB cable connection, and then

.

press

4. After successful export, The message Download is complete. Delete selected cases? appears.

• Select Yes to delete the exported cases from the device.

• Select No to keep the exported cases stored in the device.

5. Remove the USB cable.

33

14.5 Deleting case data

1. To delete cases, select desired cases, and then press Delete on the case list screen.

2. Press Yes to accept the deletion. Press No to reject the deletion.

Figure 34. Delete selected cases screen

15 Ending a case

1. If necessary, turn off the vacuum by pressing

2. Document the case results.

3. Turn off the device by pressing for 1.5 s. Unplug the power cord from the supply mains.

4. Cover all exposed ports and connectors of the disposables.

5. Close all tubing clamps.

6. Unlock and open the manifold cover.

7. Pull the pump lever and remove the tubing from the pump.

8. Remove the reservoir, centrifuge bowl, tubing harness, waste bag, vacuum line, and all solution containers from the device.
Warning: Only clamp the waste line after the disposables have been removed.

9. Follow hospital procedures when disposing of biohazardous waste.

10. Clean the device in accordance with hospital protocols and as described in Chapter 16.

.

16 Cleaning the device

Warning: Use appropriate personal protective equipment such as eye protection, mask, and gloves when cleaning the device and

discarding used fluids. Failure to do so could result in exposure to bloodborne pathogens, blood, and cleaning fluids.

Warning: If it is suspected that fluid has entered the device, it should be immediately examined by a trained technician. Fluid ingress
could result in electric shock to the user.

Warning: Clean and maintain the device in accordance with this manual and hospital procedures.

Component/area

External 1. Any time the external portions of the device become dirty (for example, blood spills), they

Level sensor If blood or other solutions are spilled in the centrifuge chamber, or dust builds up on the level sensor

Air detector and valve
assembly

Cleaning

should be cleaned according to approved hospital protocols with a 10% bleach solution or
equivalent disinfectant solution.

2. After cleaning, wipe the device with a cloth and water to remove any disinfectant solution
residue. Do not use alcohol.

3. Allow the device to dry.

during use, the sensor can become inoperative.

1. To clean the level sensor, use a foam-tipped swab dipped in a mild detergent and water.
Caution: Do not use liquids that may leave a film, such as alcohol. Do not use an abrasive

cloth.
Note: To clean blood spills, use a 10% bleach solution or equivalent disinfectant solution.

2. Carefully wipe across the sensor to remove any blood, dust, or debris.

3. Carefully wipe across the sensor with another foam-tipped swab to remove any remaining
moisture.

1. To clean the air detector or valve assembly, use a foam-tipped swab dipped in a mild detergent
and water.

Caution: Do not use liquids that may leave a film, such as alcohol. Do not use an abrasive
cloth.

34

Component/area Cleaning

Note: To clean blood spills, use a 10% bleach solution or equivalent disinfectant solution.

2. Carefully wipe across the air detector or valve assembly to remove any blood, dust, or debris.

3. Carefully wipe across the air detector or valve assembly with another foam-tipped swab to
remove any remaining moisture.

Centrifuge 1. If blood or fluids spill in the centrifuge chamber, turn off the device.

2. Remove the wash kit.

3. To collect disinfectant solutions during the cleaning process, slide the empty tray from the
wash kit into the wash kit tray holder under the device, from the right side. Tilt the tray slightly
upward in order to insert the edges of the tray into the wash kit tray holder.

4. Confirm that the wash kit tray is correctly installed.
Warning: While cleaning the centrifuge, failure to correctly install the tray for fluid collection will

lead to spillage.
Note: The centrifuge drain is equipped with female pipe threading (1/4-18 NPT). If desired, a

customized fluid container can be used to collect fluids, instead of using the wash kit tray.

5. Turn on the device.

Pump head

Vacuum overflow trap

6. Press

7. Press Clean centrifuge.

8. Press to start the centrifuge rotating.

9. Over a 1 min to 2 min period, slowly pour 100 mL of a 10% bleach solution or equivalent

10. Over a 1 min to 2 min period, rinse the centrifuge by slowly pouring 100 mL of water into the

11. Press

12. Dispose of the used cleaning solutions in accordance with hospital procedures for the dis-

13. Dry the chamber with a soft cloth. Do not use alcohol to clean the centrifuge chamber. Remove

Clean the exterior and interior of the pump head after every use. To clean the pump head, perform
the following procedure:

1. Turn off the device and unplug the power cord from the supply mains.

2. Pull back the pump lever with one hand.

3. With the other hand, lift the pump head up and off of the shaft.

4. Release the pump lever.

5. Clean the spilled fluids from the pump head as much as possible, using towels and foam-

6. Ensure that the pump head rollers move freely. Clean the pump head rollers with soap and

7. To reinstall the pump head onto the shaft, pull back the pump lever with one hand.

8. With the other hand, rotate the pump head while applying pressure until the keyed slot in the

9. Release the pump lever.

1. After every use, examine the vacuum overflow trap for fluids or contamination.

2. If fluids are present or if the vacuum overflow trap is dirty, remove, disassemble, and clean the

3. Rinse with water and allow the components to dry prior to reassembly and reconnection to the

on the touchscreen to access the Service and maintenance screen.

Warning: Failure to press will result in the centrifuge not rotating and a failure to effectively
clean the centrifuge.

disinfectant solution into the centrifuge chamber while it is rotating until it starts to overflow.
During rotation, fluid will spin out of the centrifuge and into the tray. Continue adding solution
until the centrifuge is clean.

Warning: While cleaning the centrifuge, failure to add sufficient volume of a 10% bleach
solution or equivalent disinfectant solution for a sufficient duration can lead to ineffective
cleaning.

centrifuge chamber.

.

Caution: Failure to press can lead to minor injury if the chamber is contacted while it is
spinning.

posal of biohazardous waste.

and empty the tray.

Caution: Be careful not to injure fingers in the pump lever.

tipped swabs dampened with a 10% bleach solution or equivalent disinfectant solution. Dry
the area thoroughly.

Caution: Failure to thoroughly dry the area can result in corrosion.

water or with water alone. Dry the area thoroughly.

pump head aligns with the shaft and the pump head begins to slide onto the shaft.
Note: The dimple on the pump head aligns with the shaft when the pump head slides onto the

shaft.

vacuum overflow trap according to approved hospital protocols with a 10% bleach solution or
equivalent disinfectant solution.

device.

35

Component/area Cleaning

Storage tray 1. Any time the storage tray becomes dirty (for example, blood spills), it should be removed and

Internal storage compart­ment

Touchscreen

Barcode scanner For barcode scanner cleaning instructions, refer to the literature included with the scanner.

cleaned according to approved hospital protocols with a 10% bleach solution or equivalent
disinfectant solution.

2. After cleaning, wipe the tray with a cloth and water to remove any cleaning solution residue. Do
not use alcohol.

3. Allow the storage tray to dry before reinstalling.

1. Whenever the internal storage compartment becomes dirty (for example, blood spills), it
should be removed and cleaned.

2. To remove the storage compartment, open it.

3. Retract the spring plunger in the upper left corner on the inside of the compartment, and open
the compartment completely.

4. Lift the compartment off of the 2 pins in the device front panel.

5. Clean the compartment and the area inside the device from which the compartment was
removed according to approved hospital protocols using a 10% bleach solution or equivalent
disinfectant solution.

6. After cleaning, wipe with a cloth and water to remove any cleaning solution residue. Do not use
alcohol.

7. Allow the storage compartment and device to dry before reinstalling.

8. To reinstall the compartment, align the sockets on the bottom of compartment with the 2 pivot
pins in the device front panel.

9. While closing the compartment, retract the spring plunger in the upper left corner of the com­partment. Release the spring plunger once it has passed the compartment stop plate.

Clean the touchscreen with a soft, lint-free cloth.
Warning: Do not use bleach to clean the touchscreen, as this could discolor the screen and result
in failure.

17 Special blood processing conditions

Note: The following steps should be followed in conjunction with normal setup steps in Section 13.3.

17.1 Emergency setup using multiple suction/anticoagulant lines on 1 reservoir

The setup for this configuration is similar to that used for a normal case.

36

Figure 35. Emergency setup

1 Anticoagulant solution containers
2 Suction/anticoagulant lines to patient
3 Blood collection reservoir

1. Collect additional supplies necessary for this configuration:

• Suction/anticoagulant line

• Adequate quantity of anticoagulant solution

2. Attach the vacuum line to the yellow-capped port on the collection reservoir.

3. Attach the other end of the vacuum line to a regulated vacuum source.

4. Attach the blue-capped connector of the additional suction/anticoagulant line to one of the available inlet ports on the collection
reservoir.

5. Close the roller clamp on the suction/anticoagulant line. If the anticoagulant container is nonvented, spike the anticoagulant
container and open the vent cover on the drip chamber.

6. Spike the additional anticoagulant container for the second suction/anticoagulant line.

4 Step-down connector to device
5 Vacuum line to regulated vacuum source

17.2 Using 2 reservoirs in series

Note: If necessary to transition to 2 collection reservoirs midcase, follow the steps in this section.

37

Figure 36. Using 2 collection reservoirs in series

1 Anticoagulant solution
2 Suction/anticoagulant line to patient
3 Primary blood collection reservoir
4 Step-down connector to device

6 Step-down connector from secondary collection reservoir to

primary collection reservoir inlet port
7 Vacuum line to regulated vacuum source
8 Vacuum line to device

5 Secondary blood collection reservoir

1. Collect additional supplies necessary for this configuration:

• Blood collection reservoirs

• Suction/anticoagulant line

• Adequate quantity of anticoagulant solution

• Vacuum source, if necessary

• Vacuum line, if necessary

• Medtronic cardiotomy reservoir holder E302, which attaches to an external IV pole
Warning: Do not attach a reservoir to the device IV pole using a reservoir holder such as the Medtronic E302. The weight

of a filled reservoir attached to the device IV pole may cause tipping.

2. Attach a second reservoir holder to an external IV pole, above the primary collection reservoir.

3. Attach a step-down connector to the bottom of the secondary collection reservoir. Ensure that the connector is fully secured.

4. Place the secondary collection reservoir into the holder above the primary reservoir holder.

5. Connect the step-down connector from the secondary collection reservoir to an available inlet port on top of the primary
collection reservoir, and close the clamp on the step-down connector.

6. If using 1 regulated vacuum source, connect tubing from a dual vacuum assembly to the yellow-capped ports on each
collection reservoir. Connect the single tubing from the dual vacuum assembly to the vacuum source.

Note: The dual vacuum assembly is a “T” shaped tubing component, included with the tandem reservoir Y assembly, which
connects 1 vacuum pump to the vacuum ports of the 2 reservoirs.

7. If using a secondary regulated vacuum source, attach the second vacuum line to the yellow-capped port on the secondary
collection reservoir. Attach the other end of the second vacuum line to the secondary regulated vacuum source.

8. Attach the blue-capped connector of an additional suction/anticoagulant line to one of the available inlet ports of the secondary
collection reservoir.

9. Close the roller clamp on the additional suction/anticoagulant line. If the anticoagulant container is nonvented, spike the
anticoagulant container and open the vent cover on the drip chamber.

10. Spike an additional anticoagulant container for the second suction/anticoagulant line.

38

11. Before blood collection, open the roller clamp and prime the secondary collection reservoir with a minimum of 200 mL of
anticoagulant solution.

12. Reduce the anticoagulant flow to each collection reservoir to a ratio of approximately 15 mL of solution to 100 mL of blood.

13. Monitor both collection reservoirs periodically for appropriate anticoagulation.

14. To move blood from the secondary collection reservoir to the primary collection reservoir, open the clamp on the connector to
the primary collection reservoir, and momentarily clamp the suction/anticoagulant line on the secondary collection reservoir,
using a hemostat.

15. To pause the movement of blood from the secondary collection reservoir to the primary collection reservoir, open the hemostat
on the suction/anticoagulant line to the secondary collection reservoir, and close the clamp on the connector to the primary
collection reservoir.

16. To maintain the desired vacuum setting during processing using 1 vacuum source, either clamp one of the
suction/anticoagulant lines not in use, or increase the vacuum setting to maximum.

17.3 Using 2 reservoirs in parallel

Figure 37. Using 2 collection reservoirs in parallel

1 Anticoagulant solution
2 Suction/anticoagulant line to patient
3 Primary blood collection reservoir
4 Tandem reservoir Y assembly

1. Collect additional supplies necessary for this configuration:

• Blood collection reservoirs

• Suction/anticoagulant line

• Adequate quantity of anticoagulant solution

• Tandem reservoir Y assembly

• Vacuum source, if necessary

• Vacuum line, if necessary

• 1 reservoir holder: either the type that attaches to the device rear reservoir holder mounting base (Figure 6) or the
Medtronic cardiotomy reservoir holder E302, which attaches to an external IV pole.

Warning: Do not attach a reservoir to the device IV pole using a reservoir holder such as the Medtronic E302. The weight of
a filled reservoir attached to the device IV pole may cause tipping.

2. Attach a second reservoir holder to the device rear reservoir holder mounting base or to an external IV pole.

3. Place the secondary collection reservoir into the secondary reservoir holder.

4. Do not attach the step-down connector to either collection reservoir. Instead, use a tandem reservoir Y assembly to connect
the primary and secondary collection reservoirs. Connect the single tubing to the secondary collection reservoir and the Y
assembly to the primary collection reservoir. Ensure that the connectors are fully secured.

5 Secondary blood collection reservoir
6 Vacuum line to the vacuum overflow trap of the device
7 Vacuum line to external regulated vacuum source

39

5. Close the clamp on the bottom of the secondary collection reservoir.

6. If using 1 regulated vacuum source, connect tubing from a dual vacuum assembly to the yellow-capped ports on each
collection reservoir. Connect the remaining tubing from the dual vacuum assembly to the vacuum source.

Note: The dual vacuum assembly is a “T” shaped tubing component, included with the tandem reservoir Y assembly, which
connects 1 vacuum pump to the vacuum ports of the 2 reservoirs.

7. If using a secondary regulated vacuum source, attach the second vacuum line to the yellow-capped port on the secondary
collection reservoir. Attach the other end of the second vacuum line to the secondary regulated vacuum source.

8. Attach the blue-capped connector of an additional suction/anticoagulant line to one of the available inlet ports of the secondary
collection reservoir.

9. Close the roller clamp on the additional suction/anticoagulant line. If the anticoagulant container is nonvented, spike the
anticoagulant container and open the vent cover on the drip chamber.

10. Spike an additional anticoagulant bag for the second suction/anticoagulant line.

11. Before blood collection, open the roller clamp and prime the secondary collection reservoir with a minimum of 200 mL of
anticoagulant solution.

12. Reduce the anticoagulant flow to each collection reservoir to a ratio of approximately 15 mL of solution to 100 mL of blood.

13. Monitor both collection reservoirs periodically for appropriate anticoagulation.

14. To move blood from the secondary collection reservoir to the primary collection reservoir, open the clamp on the connector to
the primary collection reservoir, and momentarily clamp the suction/anticoagulant line on the secondary collection reservoir,
using a hemostat.

15. To pause the movement of blood from the secondary collection reservoir to the primary collection reservoir, open the hemostat
on the suction/anticoagulant line to the secondary collection reservoir, and close the clamp on the connector to the primary
collection reservoir.

16. To maintain the desired vacuum setting during processing using 1 vacuum source, either clamp one of the
suction/anticoagulant lines not in use, or increase the vacuum setting to maximum.

17.4 Draining cardiopulmonary bypass circuit (CPB) contents to the device

1. Connect the CPB circuit to an inlet port on a collection reservoir on the device. Ensure that the connector is fully secured.

2. Drain the contents of the CPB circuit to the collection reservoir.

3. Process the blood. See Section 13.5.

17.5 Postoperative wound drainage

The following steps are only necessary if they were not completed previously for intraoperative blood processing.

The bowl and tubing setup and the operating instructions for this case are the same as those for a standard case (Section 13.4).

1. Open the sterile collection reservoir and remove the step-down connector.

2. Attach the step-down connector to the bottom of the collection reservoir. Ensure that the connector is fully secured.

3. Place the collection reservoir into a reservoir holder. Attach a vacuum line to the yellow-capped port on the collection reservoir.

4. Attach the other end of the vacuum line to a regulated vacuum source. Use an appropriate, and preferably intermittent, vacuum
source adjusted to −80 mmHg or less.

5. Aseptically pass the suction/anticoagulant line into the sterile field.

6. Attach the blue-capped connector of the suction/anticoagulant line to either the blue-capped or white-capped inlet port on the
top of the collection reservoir.

7. Close the roller clamp on the suction/anticoagulant line. Spike the anticoagulant container. If the anticoagulant container is
nonvented, open the vent cover on the drip chamber.

8. Before blood collection, open the roller clamp and prime the collection reservoir with a minimum of 200 mL of anticoagulant
solution.

9. Reduce the anticoagulant flow to a ratio of approximately 15 mL of solution to 100 mL of blood.

10. Connect the universal Y connector to the suction/anticoagulant line. When the device is turned off, stop the anticoagulant flow.
Start the anticoagulant flow when the vacuum is turned on.

11. Begin blood collection. After adequate blood volume has been collected, it can be processed by the device.

12. If simultaneous blood collection is needed for 2 drain lines, a second collection reservoir, suction/anticoagulant line with
anticoagulant container, and vacuum source may be used (with reservoirs in either series or parallel).

18 Troubleshooting guide

Note: This guide is intended to provide a simple description of common problems that can occur during use of the device, and of

the messages that appear during its operation. A brief description of the cause of the problem or message is also included.

18.1 Power failure

Normally, each time the device power is turned on, parameters are initialized to prepare it for use with a new patient. However, after
a power failure or interruption (and if the device is restarted within 6 hours), the following message appears: Resume previous

case? If Yes, bowl contents will be pumped to reservoir. Make sure the reservoir is connected.

1. To continue the previous case, select Yes.

2. To start a new case, select No.
Note: The device defaults to a new case if the device power is turned on 6 or more hours after shutdown or power loss.

40

18.2 Unusual behavior of the device

Warning: Failure to respond to unusual behavior of the device could result in blood contamination or spillage.

Monitor the device during operation, and if unusual behavior is observed, respond as described in the following table.

Unusual behavior Response

The centrifuge bowl fills with blood and then
blood returns to the collection reservoir,
repeatedly.

The bowl is vibrating or making excessive
noise.

The reservoir is making a cracking noise as
a result of negative pressure.

The barcode scanner does not work. 1. Plug the barcode scanner cord into a different USB port (type A).

1. Press to place the device in Stop mode.

2. Determine if the input volume is diluted.

3. If the input volume is diluted, transition to manual start for blood processing.

4. Examine the inner and outer surfaces of the reservoir filter for clots.

5. If clots are detected on the outside of the reservoir filter, replace the reservoir.

6. If clots are detected on the inside of the reservoir filter, prime the reservoir with
at least 200 mL of anticoagulant solution and agitate the reservoir.

7. Restart blood processing.

8. Frequently agitate the reservoir, increasing anticoagulation, for the remaining
duration of the case.

1. Press to place the device in Stop mode.

2. Remove the centrifuge bowl.

3. Examine the bowl for damage, clots, or blood contaminated with particulates.

4. Discard and replace the bowl if it is damaged or contaminated with particulates.

5. Reinstall the bowl.

6. Examine the inner and outer surfaces of the reservoir filter for clots.

7. If clots are detected in the reservoir filter, replace the reservoir, centrifuge bowl,
and tubing harness.

8. If no clots are detected in the reservoir filter, replace the centrifuge bowl and
tubing harness.

9. Prime the new disposables with at least 200 mL of anticoagulant solution.

10. Restart blood processing.

11. Frequently agitate the reservoir, increasing anticoagulation, for the remaining
duration of the case.

12. If the previous steps do not resolve the message, use another device if avail­able. Contact your Medtronic service representative.

Warning: Close all clamps and use caution if transferring the disposables to a
new device.

1. Turn off the vacuum or reduce the vacuum setting.

2. Examine the suction/anticoagulant line for obstructions.

3. Vent the reservoir.

2. Confirm that the barcode type can be read by the scanner. See Section 13.2.

3. Contact your Medtronic service representative.

18.3 Normal startup prompts, audible and visual alert signals

Normal prompts may appear during device operation or startup, and they typically can be resolved by making a quick adjustment
of the device or the disposable kit.

Prompt

Resume previous case? If Yes, bowl con­tents will be pumped to reservoir. Make
sure the reservoir is connected.

Connect the saline line and reservoir.
Press to resume.

Response Audible alert

1. To continue the previous case, select Yes.

2. To start a new case, select No.
Note: If No is selected in error, case data can

be retrieved by following steps in Section 14.1.
Note: The device defaults to a new case if the

device power is turned on 6 or more hours after
shutdown or power loss.

1. Spike the middle manifold tubing into the saline
bag or bags.

Note: If using only 1 saline bag, confirm that
the clamp on the unused line is closed.

2. Open the saline clamp or clamps.

3. Connect the left-hand tube of the manifold to
the blue-capped step-down connector at the
bottom of the reservoir.

4. Press

.

41

signal

None None

None None

Visual alert
signal

Prompt Response Audible alert

signal

Machine stopped. Press to enable self­start.

This message appears after the disposable kit is
installed. Enable self-start by pressing . The

None None

Visual alert
signal

device automatically starts when it detects approx­imately 800 mL of blood in the reservoir for at least
5 s.

Self-start enabled. Press to manually

Press to cause a manual start. None None

start.
Vacuum pressure detected at startup.

Make sure the suction line is not clam­ped. Press to resume.

This message appears if existing vacuum pressure
is detected in the reservoir when vacuum is turned
on at device startup.

Medium Medium

1. Confirm that vacuum and suction lines are not
clamped or immersed in liquid.

2. To continue, press

.

3. Press to restore vacuum.
Note: If prompt returns, the device can still be

used if an external regulated vacuum source is
connected to the reservoir. Contact your
Medtronic service representative.

18.4 Normal operating prompts, audible and visual alert signals

Normal prompts may appear during device operation or startup, and they typically can be resolved by making a quick adjustment
of the device or the disposable kit.

Prompt

Air in reservoir line. Press to try again or
select Return, Concentrate, or Wash.

Air in holding bag line. Bowl is not full.
Press to try again or select Return or
Wash.

Kit is not installed. Lock the bowl cover. A sensor has detected that the bowl cover is not

Kit is not installed. Lock the manifold
cover. Press to resume.

a

Response Audible alert

signal

The Fill phase emptied all the contents of the res-

Low Low

ervoir.

1. If possible, remove air from the reservoir line.
Press to continue filling.

2. Depending on the clinical use condition, select

Return, Concentrate, or Wash.
Warning: Choosing to wash a partially filled

bowl may result in low blood quality and low red
cell volume.

This message appears after selecting Concen-

Low Low
trate, and after the red blood cells from the holding
bag are consumed before the bowl is full.

1. Unclamp the holding bag line if necessary.

2. Press and hold to advance blood to the bowl.

3. If the previous steps do not resolve the mes­sage, select Return to return the blood to the
reservoir or Wash to wash the contents of the
bowl.

4. The centrifuge continues to spin for 1 min, and
blood is returned to the reservoir if no selection
is made.

Warning: Choosing to wash a partially filled
bowl may result in low blood quality and low red
cell volume.

None None

locked.

1. Place the bowl in the centrifuge chamber with
the yellow-capped waste line outlet tubing fac­ing the waste bag. Refer to the markings on the
top panel.

2. Align the centrifuge markings with the vertical
assemblies on the bowl.

3. To lock the bowl, simultaneously press down
on it and turn it clockwise until a click is heard.

A sensor has detected that the manifold cover is not

Medium Medium

locked.

1. Open the manifold cover.

2. Place the manifold into the recessed cavity.

Visual alert
signal

42

Prompt Response Audible alert

signal

3. Place the 3 manifold tubing lines into the tubing
guides, and ensure that each tube is fully
seated in each guide.

4. Place the single tubing line of the manifold into
the air detector, and ensure that it is fully
seated.

Note: There is a feature on the manifold cover
that pushes the tubing into the air detector
when closing the cover.

5. Rotate the manifold cover latch until the lock
indicators are aligned.

Insert the kit in the valve and the pump.
Press to resume.

a

The kit is not properly installed in either the manifold
valve or the pump.

Medium

1. Open the manifold cover.

2. Place the manifold into the recessed cavity
until the connector is fully seated in the cavity.

3. Place the 3 manifold tubing lines into the tubing
guides, and ensure that each tube is fully
seated in each guide.

4. Place the single tubing line of the manifold into
the air detector, and ensure that it is fully
seated.

Note: There is a feature on the manifold cover
that pushes the tubing into the air detector
when closing the cover.

5. Rotate the manifold cover latch until the lock
indicators are aligned.

6. Pull the pump lever and hold it open.

7. Stretch the pump tubing around the pump
head and over the pump outlet tubing guide.

8. Release the pump lever.

Bowl may not be full. Wash it? This message occurs when selecting Wash, after

Low Low

the prompts Air in reservoir line. Press to try

again or select Return, Concentrate, or Wash.
or Air in holding bag line. Bowl is not full. Press

to try again or select Return or Wash.

1. Select Yes to wash the bowl.
Warning: Choosing to wash a partially filled

bowl may result in low blood quality and low red
cell volume.

2. Selecting No stops the bowl and returns the
blood to the reservoir.

Waste bag may be full. Empty if neces­sary. Press to resume.

The device estimates the volume in the waste bag
and a notice appears when the bag is full.

Medium Medium

1. Empty the waste bag.
Note: Leave 100 mL to 200 mL of fluid in the

bag to provide for proper expansion during fill­ing and emptying.

Unlock then relock the bowl cover. Press

to resume.

2. Press

The bowl moved during rotation and is unlocked.

1. Unlock and remove the bowl.

to resume.

Medium Medium

2. Examine the centrifuge chamber for debris and
liquid.

3. Remove the debris or liquid if necessary.

4. Examine the bowl for damage.

5. Discard and replace the bowl if it is damaged.

6. If clots are observed in the bowl, discard and
replace the wash kit.

7. Confirm that the bowl sensor and sensor
spring are moving freely and not damaged or
dirty.

8. Reinstall the bowl.

Visual alert
signal

Medium

43

Prompt Response Audible alert

9. If the message is not resolved after the previ­ous steps, and if the bowl was not replaced,
then replace the bowl.

10. If the message is still not resolved, use another
device if available. Contact your Medtronic
service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Optics obstructed. Empty the bowl or
clean the optics sensor. Press to
resume.

Air in saline line. Press to resume. This message appears if the device detects air dur-

Emptying time was too short. Check the
holding bag line for air. Press to
resume.

Emptying time was too long. Check the
holding bag line for occlusions. Press
to resume.

The level sensor detects blood at the top of the bowl
when there should be no blood in the bowl.

1. Examine the bowl for blood.

2. If there is blood in the bowl, manually return the
blood to the reservoir using the FCT key (Fig­ure 21).

3. If the previous step does not resolve the mes­sage, unlock the bowl.

4. If clots are observed in the bowl, discard and
replace the wash kit.

5. If clots are observed inside the reservoir filter,
prime the reservoir with anticoagulant.

6. Agitate the reservoir vigorously.

7. If clots are observed outside the reservoir filter,
replace the reservoir.

8. If the previous steps do not resolve the mes­sage, document all fluid volumes.

9. Clean and dry the optic sensors using an
approved cleaning solution (Chapter 16).

10. If the previous steps do not resolve the mes­sage, use another device if available. Contact
your Medtronic service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

ing the prime or wash phases.

1. Confirm that the saline bags are mounted and
spiked. Mount and spike the saline bags if nec­essary.

2. If the previous step does not resolve the mes­sage, reset the alert as needed.

3. If the previous steps do not resolve the mes­sage, ensure that the tubing is correctly inser­ted into the air detector.

4. Clean the air detector and tubing with water,
and then dry.

5. If the previous steps do not resolve the mes­sage, use another device if available. Contact
your Medtronic service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Examine the disposables for air leaks.

1. Confirm that there is flow to the holding bag.

2. If no flow is observed, remove the centrifuge
bowl and examine it for clots.

Warning: Do not invert the bowl when exam­ining for clots, as this could lead to fluid leak­age.

3. If clots are observed in the bowl, discard and
replace the wash kit.

4. If no clots are observed, clean the air detector
and tubing with water, and then dry.

This message appears if the holding bag line is
clamped and the device is unable to move blood
volume from the bowl, or if the air detector has failed.

signal

Low

Low

Low Low

Low Low

Visual alert
signal

Low

Low

44

Prompt Response Audible alert

1. Examine the holding bag line for closed clamps
and other occlusions.

2. Examine the holding bag. Empty or replace the
holding bag if it is full.

3. Clean the air detector and tubing with water,
and then dry.

4. If the message is not resolved, use another
device if available. Contact your Medtronic
service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Holding bag may be full. Empty or change
if necessary. Press to resume.

Machine paused. Press to resume. The pump has been manually paused using .

Machine stopped. Press to enable self­start.

Self-start enabled. Press to manually
start.

The pump is running too slow. Check the
kit installation. Press to resume.

Centrifuge is running too slow. Check the
bowl installation. Press to resume.

The device estimates the volume pumped to the
holding bag and a notice appears when the bag is
full.

1. Empty or replace the holding bag.

2. Press .

1. Resolve the issue.

2. Press to resume.

This message appears after the disposable kit is
installed. Enable self-start by pressing . The
device automatically starts when it detects approx­imately 800 mL of blood in the reservoir for at least
5 s.

Press to cause a manual start. None None

Tubing is binding on the pump.

1. Confirm that the pump is moving. If it is moving,
proceed to the next step. If not, contact your
Medtronic service representative.

2. Ensure that the tubing is correctly inserted in
the pump tubing channel.

3. If the previous steps do not resolve the mes­sage, remove the tubing from the pump tubing
channel.

4. Remove the pump head.

5. Confirm that the pump head rollers move
freely, and are free of burrs and other debris.

6. Clean the pump head and rollers if necessary
using an approved cleaning solution (Chap­ter 16).

7. Reinstall the pump head.

8. If the previous steps do not resolve the mes­sage, use another device if available. Contact
your Medtronic service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

The bowl may be binding in the centrifuge.

1. Unlock then relock the centrifuge bowl to
ensure that it is correctly installed.

2. Remove the centrifuge bowl.

3. Examine the bowl for damage.

4. Discard and replace the bowl if it is damaged.

5. Examine the centrifuge chamber for debris and
liquid.

6. Examine the centrifuge chamber for binding by
moving the chamber by hand. If it is binding,
contact your Medtronic service representative.

7. Remove the debris or liquid if necessary.

8. Reinstall the bowl and confirm normal opera­tion.

9. If the previous steps do not resolve the mes­sage, document all fluid volumes.

signal

Medium Medium

None Low

None None

Medium

Medium

Visual alert
signal

Medium

Medium

45

Prompt Response Audible alert

signal

10. Turn off the device, then turn it on.

11. If the previous step does not resolve the mes­sage, use another device if available. Contact
your Medtronic service representative.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Reservoir weight not detected. Self-start
not available. Press to manually start.

The weight sensor does not detect the reservoir.

1. Mount the reservoir in the reservoir holder

Notify None

(enabling self-start) if self-start mode is
desired.

2. Or, press to manually start.

FCT 1: Empty the bowl to the reservoir.
Press and hold to run the pump. Press

when complete.

FCT 2: Empty the bowl to the holding bag.
Press and hold to run the pump. Press

when complete.

FCT 3: Invert the holding bag. Press and
hold to remove air. Press when com­plete.

Vacuum pressure exceeded the setting.
Make sure the suction line is not clam­ped. Press to resume.

FCT 1 was selected while the device was in Stop
mode. These functions enable the pump to be man­ually engaged.

FCT 2 was selected while the device was in Stop
mode. These functions enable the pump to be man­ually engaged.

FCT 3 was selected while the device was in Stop
mode. These functions enable the pump to be man­ually engaged.

This message appears if the device vacuum system
could not regulate the vacuum pressure, possibly
because of a clamp on the vacuum line between the

None None

None None

None None

Medium Medium

fluid trap and the reservoir.

1. Confirm that vacuum and suction lines are not
clamped or immersed in liquid.

2. To continue, press

.

3. Press to restore vacuum.

4. If the previous steps do not resolve the issue,
turn off the power, then turn it on, and retry.

Note: If prompt returns, the device can still be used
if an external regulated vacuum source is connected
to the reservoir. Contact your Medtronic service
representative.

a

Prompt will have different audible and visual alert signals when issued during setup.

Visual alert
signal

18.5 Error prompts, audible and visual alert signals

Error prompts may appear during device operation or startup.

Error

The vacuum system failed. Vacuum is not
available. Press to resume.

Response Audible alert

signal

This message appears if the device vacuum system

Medium Medium

has failed.

Visual alert
signal

1. Confirm that vacuum and suction lines are not
clamped or immersed in liquid.

2. Turn off the power, then turn it on, and retry.

3. If the previous steps do not resolve the issue,
contact your Medtronic service representative.

Note: The device can still be used if an external
regulated vacuum source is connected to the
reservoir.

18.6 Irrecoverable errors, audible and visual alert signals

These errors cannot be recovered by the device or user. The device should be taken out of service until it is examined by a Medtronic
service representative or biomedical equipment technician trained and certified by Medtronic.

Error

Failure of any of the following components
will produce a message containing the com­ponent name, the error code, and a state­ment to contact Medtronic for service:

• Air detector

• Centrifuge

Response Audible alert

signal

Contact your Medtronic service representa-

Medium Medium
tive, and provide the error code displayed on
the screen.

Warning: Close all clamps and use caution if
transferring the disposables to a new device.

Visual alert
signal

46

Error Response Audible alert

signal

Visual alert
signal

• Diagnostic hardware

• External A/D convertor

• Level sensor

• Weight sensor

• Device microprocessor

• Roller pump controller

• Power supply

• Valve

• GUI communications

• Keypad

• Temperature sensor

• SD card

• NVRAM

• Vacuum system

• System controller

• System error

a

No visual alert signal is issued.

b

No audible alert signal is issued; message to contact Medtronic does not appear.

a

b

19 Service and maintenance

19.1 Service interval

A notification appears when maintenance is due.

Warnings – Read and follow all of the following warnings when servicing or maintaining the device.

• Contact your Medtronic service representative, or a biomedical equipment technician trained and certified by Medtronic, to
perform preventative maintenance and calibration of the device. Preventative maintenance and calibration should be performed
on an annual basis. Blood spillage, biohazard risk, low blood quality, slip hazard, and other concerns, could result if preventative
maintenance and calibration are not performed.

• Always turn off and unplug the device prior to working inside the cabinet or changing any fuses. Inside the cabinet are various
electrical components and wiring. Physical contact with any of these components while the device is plugged in could result in
severe electrical shock. For continued protection against risk of fire, replace fuses only with the same type and rating. Fuses
should be replaced by a Medtronic service representative or Medtronic-trained and certified biomedical equipment technician.
Internal grounding is provided for safety.

• Enclosure current leakage is a primary indicator of electrical shock hazard to personnel making contact with any exposed
portion of the equipment. Each device is tested during the final quality inspection to verify enclosure current leakage is less than
100 µA (under normal operating conditions) and less than 300 µA (under single-fault conditions). Ensure that the current
leakage is tested at least once a year, or more frequently as required, by the operating facility’s biomedical engineering
department or other qualified service technician. In addition, always test the enclosure current leakage and insulation after an
event such as a fluid spill, after a major voltage surge in the power source has occurred, or after any device repair.

Note: Contact your Medtronic service representative for replacement packaging prior to returning the device to Medtronic.

19.2 Pump head

• The tubing guides and pump head should be examined periodically for burrs and sharp edges that could lead to tubing damage
and failure. Contact your Medtronic service representative if any defective or damaged parts are observed.

• Ensure that the pump head rollers move freely.

19.3 Service and maintenance screens

1. To view service and maintenance screens, press

2. Select the desired field.

.

47

Figure 38. Service and maintenance screen

1 Current device notifications
2 Current device information such as software operating system, graphical user interface, and system controller

versions; serial number; and device, centrifuge, roller pump, and vacuum pump run times
3 Logged device errors
4 Allows the user to calibrate the touchscreen
5 Allows the user to perform the centrifuge cleaning operation
6 Allows the service technician to perform authorized software updates
7 Export service information (not shown): Allows the user to export notifications, device information, and error logs

19.4 Notifications

Notifications provide information about device conditions that are important but do not stop device operation. The presence of a
notification is indicated by a yellow outline on the and the Reset alert field (Figure 39), and on the Notifications field of the
Service and maintenance screen (Figure 38). The following information describes the appearance and behavior of device
notifications:

• A new notification, or a postponed notification that has reappeared, causes yellow outlines to appear in the screen areas
described previously.

• Pressing the Reset alert field allows the user to postpone a yellow-outlined notification. Postponing the notification causes the
yellow outlines to disappear from the screen areas described previously. The following reset options are available:

– Minutes: Select this option, and then use
– Cases: Select this option, and then use and to set the number of cases before a notification reappears.
– Forever: For applicable notifications, select this option and the notification will not reappear.

• Notifications disappear entirely once the underlying condition is corrected. For example, the notification Max vacuum is still
set. Adjust if necessary. disappears after the vacuum setting is changed.

• Active notifications, whether yellow-outlined or not, can be accessed by pressing Notifications from the Service and
maintenance screen.

• If there are active notifications, and if there are no higher-priority prompts also active, the notifications will continuously appear
(scroll) in the Prompts area of the Main screen.

The following table contains a list of device notifications:

Table 2. Notifications, audible and visual alert signals Notification Description Audible alert

Maintenance due in __ days. The device begins counting down when mainte-

The real-time clock failed. See error log
for details. Contact Medtronic for service.

Max vacuum is still set. Adjust if neces­sary.

Emergency wash is still set. Adjust if nec­essary.

Case records will not be stored unless a
password is set in Settings.

and to set the number of minutes before a notification reappears.

signal

nance is due in 30 days, and updates the counter
daily. Contact your Medtronic service representa­tive to perform maintenance on the device.

Case records will not contain an accurate time
stamp. Contact your Medtronic service representa­tive.

Max vacuum has been set for 10 min or more. If
Max vacuum is not desired, change the vacuum

setting as shown in Section 13.3.
Emergency wash has been set for 10 min or more.

If Emergency wash is not desired, change the
Wash volume setting as shown in Section 13.5.1.

Set the password, in order to store case records as
shown in Section 12.4.

None Low

None Low

None Low

None Low

None Low

Visual alert
signal

48

Table 2. Notifications, audible and visual alert signals (continued)
Notification Description Audible alert

The SD card failed. See error log for
details. Contact Medtronic for service.

The vacuum system failed. See error log
for details. Contact Medtronic for service.

Storage available for only __ more case
records. Export and delete records
before they are overwritten.

The GUI communications failed. See
error log for details. Contact Medtronic for
service.

The keypad failed. See error log for
details. Contact Medtronic for service.

Figure 39. Notifications screen

The service log is not functional. Contact your
Medtronic service representative.

The vacuum system is not functional. Contact your
Medtronic service representative.

Device internal data storage contains 90 or more
case records. Delete records as described. See
Section 14.5.

There is a problem with the internal electronics.
Contact your Medtronic service representative.

The or control is not functioning properly.
Contact your Medtronic service representative.

signal

None Low

None Low

None Low

None Low

None Low

Visual alert
signal

19.5 System information

To view system information (software versions and runtime statistics) press System information from the Service and
maintenance screen.

19.6 Error log

To view device errors, press Error log from the Service and maintenance screen.

19.7 Calibrate touchscreen

Note: This function is not available during blood processing.

Note: If the touchscreen is inoperable, press and hold for 10 s to calibrate the touchscreen. Follow the instructions that appear

on the screen after 10 s.

1. Press

2. Wait until the device is fully stopped. The message Machine stopped. Press to enable self-start. appears.

3. Press Calibrate touchscreen from the Service and maintenance screen.

4. Follow the instructions on the screen.

to stop processing if necessary.

19.8 Clean centrifuge

For instructions for cleaning the centrifuge, press Clean centrifuge from the Service and maintenance screen. Follow the
instructions on the screen. See Chapter 16 for full cleaning instructions.

19.9 Update software

Contact your Medtronic service representative to perform software updates.

19.10 Export service information

1. To export information for service, press Export service information from the Service and maintenance screen.

2. Insert a USB flash drive into a USB port (type A).
Caution: Use only a USB flash drive provided by Medtronic.

3. Press Download to USB.

4. The message Download is complete. appears. Press OK.
Note: If the download is unsuccessful, the message Download failed appears.

49

20 Device disposal and ownership transfer

20.1 Deleting case data

Delete all case data before disposing or transferring ownership of the device (Section 14.5).

20.2 End of life disposition

Contact your Medtronic service representative before disposing of the device.

21 Specifications

21.1 Technical specifications

Electrical classification Class I, Type BF (suction/anticoagulant line), Ordinary, Contin-

Power

Voltage 100 V~ to 240 V~
Frequency 50 Hz / 60 Hz
Phase Single
Current 10 VA to 425 VA
Fuses 7 A / 250 V slow blow, 3AG, 200 A breaking capacity (Littelfuse

Power cord 3 prong hospital grade connector (varies by geography); length

Speed, flow rate, and pressure

Centrifuge 0 rpm to 10 000 rpm (±5%)
Pump 0 mL/min to 1 000 mL/min (±7%)
Vacuum −10 mmHg to −370 mmHg ±( |[5%]| + 8 mmHg)

Weight sensor Self-start: 800 mL ±400 mL
Dimensions

Width 69 cm (27 in)
Height (without IV pole) 80.5 cm (31.7 in)
Depth 42.5 cm (16.7 in)

Weight (device including IV pole) 50 kg (110 lb)
IP rating IPX1
Temperature limit

Operational 15°C to 30°C (59°F to 86°F)
Storage (clinic) 15°C to 30°C (59°F to 86°F)
Storage (warehouse) 15°C to 30°C (59°F to 86°F)
Transit -35°C to 60°C (-31°F to 140°F)

Humidity range

Operational 25% to 70% noncondensing
Storage (clinic) 25% to 70%
Storage (warehouse) 10% to 90%
Transit 10% to 90%

Pressure range

Operational 80 kPa to 101 kPa (11.6 psi to 14.6 psi)
Storage (clinic) 80 kPa to 101 kPa (11.6 psi to 14.6 psi)
Storage (warehouse) 80 kPa to 101 kPa (11.6 psi to 14.6 psi)
Transit 59.5 kPa to 101 kPa (8.6 psi to 14.6 psi)

uous operation

0313007.MXP or equivalent)

must not exceed 3 m (118 in)

21.2 Electromagnetic compatibility declaration

• IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests.

• Class A, Group 1

Warning: The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
If it is used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate
protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or
reorienting the device.

Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 in) to any part of the device, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this device could result.

Warning: Do not stack or attach additional instrumentation to the device, in order to minimize the potential for RF interference.

Warning: Power cord and USB cable length must not exceed 3 m (118 in).

50

IEC 60601-1-2 table 4 – enclosure port

Basic EMC

Phenomenon

standard or

test method

Professional healthcare facility environment

Electrostatic discharge IEC 61000-4-2 ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated RF EM fields IEC 61000-4-3 3 V/m

80 MHz – 2.7 GHz
80% AM at 1 kHz

Proximity fields from RF wireless commu-

IEC 61000-4-3 See IEC 60601-1-2 table 9

nications equipment
Rated power frequency magnetic fields IEC 61000-4-8 30 A/m

50 Hz or 60 Hz

IEC 60601-1-2 table 5 – input AC power port (1 of 2)

Phenomenon

Basic EMC

standard

Professional healthcare facility environment

Electrical fast transients / bursts IEC 61000-4-4 ±2 kV

100 kHz repetition frequency

Surges

IEC 61000-4-5 ±0.5 kV, ±1 kV

Line-to-line
Surges

IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV

Line-to-ground
Conducted disturbances induced by RF

fields

IEC 61000-4-6 3 V

0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80% AM at 1 kHz

Voltage dips IEC 61000-4-11 0% UT; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle

and
70% UT; 25/30 cycles
Single phase: at 0°

Voltage interruptions IEC 61000-4-11 0% UT; 250/300 cycle

a

Significant power loss may cause the device to shut off.

IEC 60601-1-2 table 8 – signal input/output parts port

Phenomenon

Basic EMC

standard

Professional healthcare facility environment

Electrostatic discharge IEC 61000-4-2 ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transients / bursts IEC 61000-4-4 ±1 kV

100 kHz repetition frequency

Surges

IEC 61000-4-5 ±2 kV

Line-to-ground
Conducted disturbances induced by RF

fields

IEC 61000-4-6 3 V

0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80% AM at 1 kHz

Immunity test levels

Immunity test levels

a

a

Immunity test levels

IEC 60601-1-2 table 9 – test specifications for enclosure port immunity to RF wireless communications equipment

Test frequency

(MHz)

Band

(MHz)

Service Modulation

Maximum

power

(W)

Distance

(m)

Immunity test

level

(V/m)

Pulse modula-

385 380 – 390 TETRA 400

tion

1.8 0.3 27

18 Hz

450 430 – 470

710

704 – 787

780

GMRS 460,

FRS 460

LTE Band 13,

17

FM

±5 kHz deviation

1 kHz sine

Pulse modula-

tion

217 Hz

2 0.3 28

0.2 0.3 9745

51

IEC 60601-1-2 table 9 – test specifications for enclosure port immunity to RF wireless communications equipment

Test frequency

(MHz)

810
870

930

1 720
1 845

1 970

Band

(MHz)

800 – 960

1 700 – 1 990

Service Modulation

GSM 800/900,

TETRA 800,

Pulse modula-

iDEN 820,
CDMA 850,
LTE Band 5

GSM 1800;

CDMA 1900;

GSM 1900;

Pulse modula-

DECT;

LTE Band 1, 3, 4,

tion

18 Hz

tion

217 Hz

Maximum

power

(W)

Distance

(m)

2 0.3 28

2 0.3 28

Immunity test

level

(V/m)

25; UMTS

Bluetooth,

2 450 2 400 – 2 570

WLAN

802.11 b/g/n,
RFID 2450,

Pulse modula-

tion

217 Hz

2 0.3 28

LTE Band 7

5 240

5 785

5 100 – 5 800

WLAN 802.11

a/n

Pulse modula-

tion

217 Hz

0.2 0.3 95 500

22 Warranties

22.1 Equipment limited warranty for US customers

(US customers only)

A. This LIMITED WARRANTY provides the following assurance to the purchaser of the autoLog IQ autotransfusion system,

hereafter referred to as the “Equipment”:

(1) Should the Equipment fail to function within normal tolerances due to a defect in materials or workmanship within a period

of 1 year, commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or
replace any defective part or parts of the Equipment; (b) issue a credit to the purchaser equal to the Purchase Price, as
defined in Subsection A(2), against the purchase of the replacement Equipment; or (c) provide a functionally comparable
replacement Equipment at no charge.

(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally

comparable, or replacement, Equipment.

B. To qualify for this repair, replacement, or credit set forth in Section A, the following conditions must be met:

(1) The Equipment must be returned to Medtronic within 60 days after discovery of the defect (Medtronic may, at its option,

repair the Equipment on site).

(2) The Equipment must not have been repaired or altered outside of Medtronic’s factory in any way which, in the judgment

of Medtronic, affects its stability and reliability. The Equipment must not have been subjected to misuse, abuse, or
accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT,

INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE
EQUIPMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

(2) This LIMITED WARRANTY is made only to the purchaser of the Equipment. AS TO THE PURCHASER OF THE

EQUIPMENT AND ALL OTHERS, MEDTRONIC MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO
EXPRESS OR IMPLIED WARRANTY TO THE PURCHASER SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN
A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene

mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal,
unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions
of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this
LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the
purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this LIMITED

WARRANTY.

1

1

This LIMITED WARRANTY is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN 55432. It applies only in the United States. Areas
outside the United States should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.

52

22.2 Equipment limited warranty for customers outside the US

2

(For countries outside the US)

A. This LIMITED WARRANTY provides the following assurance to the purchaser of the autoLog IQ autotransfusion system,

hereafter referred to as the “Equipment”, that should the Equipment fail to function within normal tolerances due to a defect in
materials or workmanship within a period of 1 year, commencing with the delivery of the Equipment to the purchaser, Medtronic
will at its option: (a) repair or replace any defective part or parts of the Equipment; (b) issue a credit equal to the original
Equipment purchase price (but not to exceed the value of the replacement Equipment), against the purchase of replacement
Equipment; or (c) provide functionally comparable replacement Equipment at no charge.

B. To qualify for the repair, replacement, or credit set forth in Section A, the following conditions must be met:

(1) The Equipment must be returned to Medtronic within 60 days after discovery of the defect (Medtronic may, at its option,

repair the Equipment on site).

(2) The Equipment must not have been repaired or altered by someone other than Medtronic in any way which, in the

judgment of Medtronic, affects its stability and reliability.

(3) The Equipment must not have been subjected to misuse, abuse, or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is not responsible for any incidental or

consequential damages based on warranty, contract, tort, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory

provisions of applicable law. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to
be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portions of the LIMITED WARRANTY
shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not
contain the particular part or term held to be invalid.

2

This LIMITED WARRANTY is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN 55432. Areas outside the United States should
contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.

53

Medtronic, Inc.

*M967226A001*

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]
LifeLine Technical Support, 24-hour consultation service:
1 877 526 7890

Medtronic Perfusion Systems

7611 Northland Drive
Minneapolis, MN 55428
USA
[phone]
Customer service and product orders:
1 800 854 3570
www.perfusionsystems.com

Plexus Manufacturing Sdn Bhd

Bayan Lepas Free Industrial Zone
Phase II, 11900 Bayan Lepas
Penang
Malaysia
[phone]

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
[phone]

Canada

Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
1 800 268 5346

© 2018 Medtronic
M967226A001 1B
2018-09-10