Biosafe Smart-Max User manual

Smart-Max

Multi-functional platform

Operator’s Manual

Smart-Max

Multi-functional platform

Operator's Manual

OM - 2320

Date of release: 13 December 2013

OM – 2320 – 00 – 00

TABLE OF CONTENTS

1. Preface ....................................................................................... 1

2. Smart-Max main unit ................................................................. 9

3. Smart-Max menus .................................................................... 13

4. Cryo-SC protocol ..................................................................... 23

5. Maintenance ............................................................................. 33

6. Contacts ................................................................................... 35

OM – 2320 – 00 – 00

OM – 2320 – 00 – 00

1. Preface

1.1 Introduction to the Smart-Max device and its features

The Smart-Max uses a thermal plate for controlled cooling and heating of blood,
blood derivatives or cellular products.
The Smart-Max allows mixing of product bags by means of compressed air inside
polyurethane cuff bags.
The device can inject biological products inside product bags by means of two
peristaltic pumps.

The Smart-Max device consists of:

• Cooling/heating plate

• Universal mixing device

• Injection device

1.2 Indication for use

The Smart-Max device is intended for use in the processing of blood, blood
derivatives or cellular products in order to cryo-prepare, thaw, incubate or inject
biological products for medical purpose.
The Smart-Max device is intended for the safe and reproducible mixing of bag(s)
under regulated temperature (cooling or heating) and / or injection of biological
additives into the bag at a controlled rate.

1.3 Manufacturer

Biosafe SA is an ISO 9001 / ISO 13485 certified company, working under a number
of national and regional directives.

1.3.1 Address

Biosafe SA • Route du Petit-Eysins 1 • 1262 Eysins • Switzerland
Telephone: [phone] • Fax: [phone]

www.biosafe.ch • [e-mail]
Biosafe America, Inc. • 1225 North Loop West, Suite 120 • Houston, TX 77008 • USA

Telephone: [phone] • Fax: [phone]
www.biosafeamerica.com • [e-mail]

Biosafe Asia-Pacific Ltd. • Room 3012, 30/F, Tower 1, The Gateway, 25 Canton
Road • Tsim Sha Tsui, Kowloon • Hong Kong
Telephone: [phone]
www.biosafeasiapacific.com • [e-mail]

Biosafe Medical Device International Trading (Shanghai) Co. Ltd. • Rm 80, 38F, Park
Place No.1601 Nanjing West Road • Shanghai 200040 • China
Telephone: [phone] • Fax: [phone]
www.biosafechina.com • [e-mail]

Preface OM – 2320 – 01 – 00 1

1.4 How to use this manual

This operating manual is organized in functional sections to provide easy access to
information concerning the Smart-Max device.
Prior to using the Smart-Max device, this manual should be read in its entirety.
The Table of Contents can be used to locate specific information.

1.4.1 Proprietary clause

The content of this manual is the exclusive property of Biosafe SA.
It is strictly forbidden to reproduce and/or disseminate any of the contents without the
prior written permission of Biosafe SA.

1.5 Warnings and Precautions

1.5.1 General

To ensure safe and effective use of the Smart-Max, operation should only be
entrusted to trained personnel.
The Smart-Max equipment has not been designed for any modification by the end­user or third party.
Intervention such as modification, revision, maintenance or repair should only be
performed by approved Biosafe technicians.

Unauthorized intervention performed by the user may result in
incorrect operation of the system.

Prior to using any part of the Smart-Max, the operator should read all instructions in
this manual.
In addition, the operator must check that the equipment functions safely and ensure
proper working conditions prior to use.
A Biosafe representative should be contacted if any doubt exists concerning the use
of the Smart-Max device.

Biosafe is not liable for any injury or damage resulting from use of the Smart-Max
device that does not conform to the indications in this Operator’s Manual.

Biosafe cannot be held responsible for the quality and subsequent effects of products
processed on the Smart-Max that have undergone subsequent post-processing.

1.5.3 Blood manipulations

If blood spillage or leakage occurs, the product should be discarded (see Chapter 6
for cleaning procedures).

Gloves and protective clothing should be worn for all blood handling operations.

1.5.4 Electro-Magnetic Compatibility
Recommendations as required by IEC 60601-1-2 §6.8.2.201

Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this

Preface OM – 2320 – 01 – 00 2

accompanying document. Portable and mobile RF communications equipment can

Guidance and manufacturer’s declaration – electromagnetic emission

The Smart-Max is intended for use in the electromagnetic environment specified below. The customer or
the user of the Smart-Max should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The Smart-Max uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

RF emissions
CISPR 11

Class A

The Smart-Max is suitable for use in all establishments other
than domestic and those directly connected to the public­voltage power supply network that supplies buildings used for
domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations
/
flicker emissions
IEC 61000-3-3

Complies

Guidance and manufacturer´s declaration – electromagnetic immunity

The Smart-Max is intended for use in the electromagnetic environment specified below. The user of the Smart­Max should assure that it is used in such an environment.

Immunity test

IEC 60601

test level

Compliance level

Electromagnetic environment -

guidance

Electrostatic
discharge (ESD)

IEC 61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.

Electrical fast
transient / burst

IEC 61000-4-4

± 2 kV for power
supply lines

± 1 kV for input/output
lines

± 2 kV for power
supply lines

± 1 kV for input/output
lines

Main power quality should be that of
a typical commercial or hospital
environment.

Surge
IEC 61000-4-5

± 1 kV differential
mode

± 2 kV common mode

± 1 kV differential
mode

± 2 kV common mode

Main power quality should be that of
a typical commercial or hospital
environment.

affect Medical Electrical Equipment.
All staff involved must receive an explanation of the ESD warning symbol and

training in ESD precautionary procedures, and that the users hand should be
discharged by earth bonding (Refer to 1.8 Symbol chart and abbreviations).

The Smart-Max should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Smart-Max should be observed to verify
normal operation in the configuration in which it will be used. Tables below help to
determine such conditions.

Table 201 – Guidance and manufacturer´s declaration – electromagnetic
emission – for all EQUIPMENT AND SYSTEMS (see 6.8.3.201 a) 3))

Table 202 – Guidance and manufacturer's declaration – electromagnetic
immunity – for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6))

Preface OM – 2320 – 01 – 00 3

Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines

IEC 61000-4-11

< 5 % UT
(>95 % dip in UT )
for 0,5 cycle

40 % UT
(60 % dip in UT )
for 5 cycles

70 % UT
(30 % dip in UT )
for 25 cycles

95 % UT
(5 % dip in UT )
for 5 seconds

< 5 % UT
(>95 % dip in UT )
for 0,5 cycle

40 % UT
(60 % dip in UT )
for 5 cycles

70 % UT
(30 % dip in UT )
for 25 cycles for 115V only

95 % UT
(5 % dip in UT )
for 5 seconds

Main power quality should be that of
a typical commercial or hospital
environment. If the user of the
Smart-Max requires continued
operation during power interruptions,
it is recommended that the Smart­Max be powered from an
uninterruptible power supply or a
battery.

Power frequency
(50/60 Hz)
magnetic field

IEC 61000-4-8

3 A/m

30 A/m

Power frequency magnetic fields
should be at levels characteristic of
a typical commercial or hospital
environment.

NOTE UT is the a. c. mains voltage prior to application of the test level.

Preface OM – 2320 – 01 – 00 4

Table 204 – Guidance and manufacturer´s declaration – electromagnetic

Guidance and manufacturer´s declaration – electromagnetic immunity

The Smart-Max is intended for use in the electromagnetic environment specified below. The customer or the
user of the Smart-Max should assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Compliance level

Electromagnetic environment - guidance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80 MHz

3 V/m
80 MHz to 2,5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications
equipment should be used no closer to any part
of the Smart-Max, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.

Recommended separation distance

Pd  2.1

80 MHz to 800 MHz

Pd  3.2

800 MHz to 2,5 GHz

where p is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).a

Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.b

Interference may occur in the vicinity of
equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and
reflection from structures, objects and people.

a

Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Smart-Max is used exceeds the applicable RF compliance level above, the Smart-Max should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Smart-Max.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING (see

6.8.3.201 b))

Table 206 – Recommended separation distances between portable and mobile

Preface OM – 2320 – 01 – 00 5

RF communications equipment and the EQUIPMENT or SYSTEM -

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b))

Recommended separation distances between

portable and mobile RF communications equipment and the Smart-Max device

The Smart-Max is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Smart-Max can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Smart-Max as recommended below, according to the maximum output power of the communications
equipment

Separation distance according to frequency of transmitter

M

Rated maximum

output of

transmitter

W

150 kHz to 80 MHz

Pd  2.1

80 MHz to 800 MHz

Pd  2.1

800 MHz to 2,5 GHz

Pd  3.2

0,01

0.12

0.12

0.23

0,1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

1.6 Warranty

Biosafe’s products are designed and manufactured to provide reliable performance

when properly maintained and used in accordance with the instructions provided in
this manual. Each unit is carefully inspected and tested before shipping.
In case of equipment failure or malfunction, Biosafe will replace or repair the
concerned equipment according to the agreement in place.
Equipment failure or malfunction for reasons other than a manufacturing defect (such
as improper handling of the machine or non-compliance with the Operator’s Manual)
is not covered under the Biosafe warranty program and such equipment will be
replaced or repaired at the charge of the end-user.
Biosafe shall under no circumstances be liable for consequential or economical
damage that may be an indirect or direct consequence of a defective part.

1.7 Customer support

All Smart-Max devices are supplied with a copy of the Operator’s Manual.
In addition, competent technical staff will provide end-user training prior to use and
will be available for specific questions or clarifications.
For assistance in technical or application issues, please contact your local
representative or call Biosafe Customer Service in Switzerland + 41 22 365 2705.

Preface OM – 2320 – 01 – 00 6

1.8 Symbol chart and abbreviations

Refer to instruction manual/booklet

General warning sign

Caution

Class I

Equipment energized from an external electrical power source

Type B equipment providing a degree of protection against
electrical shocks particularly regarding allowable leakage
current

CE marking of the Smart-Max instrument

~

Alternating current

O

Power off

I

Power on

Expiry date

Not reusable, for single use only.

Date of manufacture

REF

Product number

LOT

Batch designation

Refer to chapter 6.2

Pins of connectors identified with the ESD warning symbol
should not be touched. Connections should not be made to
these connectors unless the user’s hand is discharged by
earth bonding.

Preface OM – 2320 – 01 – 00 7

Preface OM – 2320 – 01 – 00 8

2. Smart-Max main unit

2.1 General description

The Smart-Max device is intended for the safe and reproducible mixing of bag(s)
under regulated temperature (cooling and heating) and / or injection of biological
additives into the product bag at a controlled rate.

The main features of the Smart-Max are:

 USB ports to connect printer, barcode reader, memory stick and other PC

interfaces

 LAN, WLAN integration
 User selectable multi-language support
 Enhanced traceability features (e.g.: procedure report file accessible via USB

key)

 Pneumatic mixing with highly flexible pouches
 Universal cooling plate for small and large cryobags.
 Temperature range involves both cooling and heating between 1°C - 45°C.
 2 peristaltic pumps for injection of cryopreservation solution and other

reagents, with the possibility of two parallel injections

 Remote access via internet connection

Smart-Max main unit OM – 2320 – 02 – 00 9

Mode

Operation

Storage & Transport

Temperature*

+7°C to +27°C

0°C to 45°C

Relative

humidity

30% to 75%, non-condensing

20% to 75%, non-condensing

Maximum

Altitude

2000m, 80 kPa

2000m, 80 kPa

Installation, assembly and modification of the Smart-Max must be done by an approved

Biosafe technician

2.2 Operating and storage requirements

2.2.1 Environmental specifications

The Smart-Max must only be operated under the following environmental conditions:

*The stand-by functioning temperature is +10°C
*Tolerance of the temperature displayed on the screen is +/-1°C
*Tolerance of the injected volume is 5%

The Smart-Max should:

 only be operated on a flat, stable, horizontal and clean surface
 be used in an open environment to allow sufficient ventilation
 be cleaned regularly
 be kept upright during transport
 be connected to a grounded power supply directly (no adapters or

extension leads)

 be installed such that the power switch (located on the back of the machine)

is accessible to power off the device without difficulty

The Smart-Max should not be exposed to:

 direct sunlight or strong light sources
 liquids or corrosive substances
 physical shocks or vibrations
 heavy weights
 other equipment that contains magnets or generate

magnetic/electromagnetic fields (such as mobile phones)

Smart-Max main unit OM – 2320 – 02 – 00 10

8. Peristaltic pumps

5. Bag pole

holder

1. Cover

2. Syringe

holder

3. Closing mechanism

4. Touch screen

6. Pneumatic bags

for mixing

7. Base plate

(small and large bags)

9. Stop button

2.3 Smart-Max Main Processing Unit – Components

Smart-Max main unit OM – 2320 – 02 – 00 11

1. Cover

Cover to close or open after bag insertion or removal

2. Syringe holder

Syringe holder adapted for different syringe sizes

3. Closing mechanism

Closing mechanism to lock cover in place

4. Touch screen

Color touch screen

5. Bag pole holder

Support to hang the input, source and other bags. Safe working load is up to 1kg

6. Pneumatic bags for mixing

Pneumatic pouches activated by air pressure

7. Base plate (small and large bags)

Base plate that can accept bags of varying size and volume

8. Peristaltic pumps

Two peristaltic pumps for controlled solution injection

9. Stop button

Stop button to abort a procedure in case of emergency

2.4 Technical specifications of the Smart-Max

Type of protection against electric shock: Class I equipment.
Degree of protection against electric shock: Type B applied part.

For cleaning procedure, please refer to Chapter 6.1

2.4.1 Dimensions (approximate):

Width: 27 cm (10.6”)
Length: 32 cm (12.7”)
Height: 17 cm (6.7”)

2.4.2 Weight:

8.5 kg (18.7 lbs)

2.4.3 Power:

Use only the original certified cable for the power supply.
The Smart-Max equipment should always be connected to an Uninterruptible Power
Supply (UPS).

Input range: 100 to 240 VAC (The Smart-Max automatically adjusts for the
local supply voltage)
Input frequency: 50/60 Hz
Consumption: 250 VA

Smart-Max main unit OM – 2320 – 02 – 00 12

3. Smart-Max Menus

To ensure correct usage of the touch screen display, the user should allow a 1
second delay between each touch of the screen.

3.1 Starting Menu

Upon switching on the Smart-Max, an automatic test is performed and the starting
menu is displayed (Fig. 1).

Fig.1

3.2 Smart-Max Menu

3.2.1 Protocol description

Press the protocol icon to display the list of applications available (Fig. 2):
For each application, the respective protocol can then be selected and launched. For

specific instructions on each protocol, please refer to the corresponding chapter
below.

Smart-Max menus OM – 2320 – 03 – 00 13

Fig.2

3.2.2 Settings and Data functions

Settings and Data functions can be accessed by pressing the Menu key. The
settings menu includes a service sub-menu which should only be used by Biosafe
service technicians (Fig. 3).

Smart-Max menus OM – 2320 – 03 – 00 14

Fig.3

3.2.3 To change language

Select the “Language” icon and choose the appropriate option (Fig. 4).

Fig. 4

3.2.4 Traceability settings

The Smart-Max can be used with a Traceability Kit composed of a printer and a
barcode reader.

This Traceability Kit enables the traceability function for both the procedure and the
protocol. Report files can be printed directly by the printer supplied as part of the
Traceability Kit. Full protocol data (logfiles) can be downloaded to the USB key
provided with the Smart-Max.

Enabling of the traceability option requires a password. Biosafe provides traceability
option passwords to approved operators.

Select “Edit” on the traceability label in order to input or scan text/values (Fig. 5 and

6).

Smart-Max menus OM – 2320 – 03 – 00 15

Fig. 5

Fig. 6

Pressing returns the display to the main screen.

Smart-Max menus OM – 2320 – 03 – 00 16

3.2.6 Saving data options

In order to save protocol data, select the “Data” icon which allows the displaying of
various reports available at the end of each procedure (Fig. 7).

Fig. 7

The report files contain statistical information on the procedure, including:

• Date and time of processing

• Temperature

• Volume

These values ensure that the process has been performed correctly and that the
product has suffered no extreme conditions.

The logfiles (protocol data) provide more technical information, including:

• Sensors recordings

• Power supply data

These files are used by Biosafe technicians to diagnose the cause of malfunctions.
The report files are pdf files generated from summary files and include a graph of the

procedure.
Once either “Report Files”, “Save Log Files” or “Save Support File” has been chosen

from the Data menu (Fig. 7), a list of files is displayed along with several options. The
files are identified by the time and date they were created (corresponding to the end
of the procedure).

All files can be saved simultaneously, using the “Save all Files” option. Alternatively,
individual files can be saved by selecting them and using “Save selected Files”.

Smart-Max menus OM – 2320 – 03 – 00 17

3.3 Protocol Running

The following screen appears when a Smart-Max protocol is running (Fig. 8).

The screen indicates the following:

1. Procedure phase

2. Remaining procedure time (seconds)

3. Added reagent/solution volume into bag(s)

Fig. 8

3.4 Troubleshooting

3.4.1 General

This chapter describes various alarms that can happen during a procedure, and the
actions that need to be taken in such cases.

Warnings and errors are signaled by an alarm.
“Warning” messages allow the procedure to continue once the problem has been
fixed.
“Error” messages do not allow the procedure to continue and will require the
operator to restart it (Fig. 9).

Smart-Max menus OM – 2320 – 03 – 00 18

WARNING MESSAGES

WARNING

ID

DESCRIPTION

CORRECTION

COVER_OPENED

9018

Warning for cover

open.

Close the cover and continue

the procedure.

WARN_TEMPERATURE_LOW

9022

Warning

temperature low.

Temperature was detected

by the protocol as low.

Continue the procedure. If

the warning persists, contact

Biosafe support.

WARN_TEMPERATURE_HIGH

9023

Warning

temperature high.

Temperature was detected

by the protocol as high.

Continue the procedure. If

the warning persists, contact

Biosafe support.

Fig. 9

When an “Error” message appears, you are asked to perform the following steps:

1. Read and write down the error message

2. Press to turn off the alarm

When an error occurs, please inform Biosafe service.

3.4.2 Warning messages during the procedure

Smart-Max menus OM – 2320 – 03 – 00 19

ERROR MESSAGES

ERROR ID

DESCRIPTION

CORRECTION

TEMP_1_HIGH
TEMP_2_HIGH
TEMP_3_HIGH

TEMP_12_HIGH

10000
10100
10200
10400

The temperature

measured by the

sensors on the

base plate is high.

Switch-off the Smart-Max

device and wait for a few

minutes to let the device cool

down.

Check that air vents are not

obstructed and restart the

Smart-Max.

If the error persists, call

Biosafe support.

TEMP_5_HIGH

10600

The internal

temperature is

high.

TEMP_1_OUT_OF_RANGE
TEMP_2_OUT_OF_RANGE
TEMP_3_OUT_OF_RANGE

11000
11100
11200

Temperature

sensor on the base

plate is not
functioning

properly.

Switch-off the Smart-Max

device and wait for a few

seconds, then restart.

If the error persists, call

Biosafe support.

TEMP_5_OUT_OF_RANGE

11400

Internal

temperature sensor

is not functioning

properly.

PRESSURE_HIGH

PRESSURE_MAXIMUM

COMPRESSOR_POWER_HIGH

PRESSURE_OUT_OF_RANGE

12000
12050
12100
12200

The mixing

mechanism is not

functioning

properly.

Switch-off the Smart-Max

device and wait for a few

seconds, then restart.

If the error persists, call

Biosafe support.

FAN_DISCONNECTED

FAN_SPEED_LOW

13000
13100

The rear fun is not

functioning

properly.

Switch-off the Smart-Max

device and wait for a few

seconds, then restart.

If the error persists, call

Biosafe support.

PELTIER_POWER_CIRCUIT

14000

Temperature

controlling system

not functioning

properly.

Switch-off the Smart-Max

device, wait few seconds and

then restart.

If the error persists, call

Biosafe support.

COVER_OPENED

15000

Cover has been

opened during a

procedure.

Close the cover and restart

the procedure. Ensure to

check and adapt parameters

(see troubleshooting guide

specific for each protocol).

ELEMENT_EXCEPTION

19999

Software error in

hardware element

handling.

Switch-off the Smart-Max

device, wait few seconds and

then restart.

If the error persists, call

Biosafe support.

SOFTWARE_EXCEPTION

20000

Software error

occurred.

Switch-off the Smart-Max

device, wait few seconds and

then restart.

If the error persists, call

Biosafe support.

DEVICE_STOP

10133

STOP key was

pressed.

Validate to restart when

ready.

3.4.3 Error messages during the procedure

Smart-Max menus OM – 2320 – 03 – 00 20

PROTOCOL_ABORT

10134

Cancel/abort

button was

pressed.

The user aborted the

procedure. Start the

procedure again.

PROTOCOL_ERROR

10135

An undefined
protocol error

occurred.

A problem with the protocol

was detected. If the problem

persists, contact Biosafe

support.

MICROCONTROLLER_COMM

20100

An error occurred

in the internal

machine

communication

with the

microcontroller

Switch-off the Smart-Max

device, wait few seconds and

then restart. If the error

persists, call Biosafe support.

3.5 Using the Smart-Max

The user must ensure proper working and environmental conditions, and
check that the equipment functions safely prior to usage.

Smart-Max menus OM – 2320 – 03 – 00 21

Smart-Max menus OM – 2320 – 03 – 00 22

4. Cryo-SC protocol

The user must ensure proper working and environmental conditions, and
check that the equipment functions safely prior to usage.

The Cryo-SC protocol is designed to allow injection of cryoprotectant solution in
volume reduced cord blood with volumes between 10 and 25 ml (before
cryoprotectant solution addition). The Smart-Max device allows a single cord
procedure at a time or two units in parallel.

4.1 Protocol selection

Switch on the Smart-Max AS-310 and wait until the starting menu is displayed. To
prepare bag(s) for the procedure, it is suggested to cool them down to the desired
temperature (e.g. 4°C) with the Smart-Max by using the pre-cooling feature or in a
standard fridge.

In the main menu, select the protocol icon and enter the Cryo-SC protocol by
pressing on the corresponding icon. This selection automatically triggers the cooling
system to begin reaching the desired temperature of 4°C.

Cryo-SC protocol OM – 2320 – 04 – 00 23

Leave the Smart-Max cover closed at all times, opening it only to insert or
remove bags. This ensures the device will reach the required temperature in
the fastest time.

Fig. 1

In the protocol menu (Fig. 1), press to select desired bag configuration.
Selection includes solution addition to a single bag, or two bags in parallel.

If only a single small bag is used, ONLY the right side is selectable and bag
must be placed on right side of the plate.

Make your choice by clicking on the appropriate icon (1 or 2 small bags), then select

to return to the general menu of the protocol (Fig. 1).

4.2 Cryobag preparation and installation on Smart-Max

Prepare cryoprotectant solution to be added to volume-reduced cord blood following
your own validated procedure, in a 10 or 20 ml syringe.

The unit head of processing is responsible for choosing and validating the
cryoprotectant solution and quantity to be added for cryopreservation.

Under aseptic conditions, or using a closed kit, connect the syringe containing the
cryoprotectant solution to the FA-100.1 DMSO extension line. The other end of the
FA-100.1 DMSO extension line should be connected to the cryobag containing the
volume reduced cord blood.

Cryo-SC protocol OM – 2320 – 04 – 00 24

For specific characteristics of Biosafe’s single-use kits, please refer to the
related Cryopreparation chapter of the Operator’s Manual which describes

connection and preparation of the cryobag for addition of cryopreservation
solution.
Please remember that is necessary to add an extra amount corresponding to
the dead volume of the tubing (1.5 ml) and of applicable, the DMSO filter (1 ml).

Once the FA-100.1 DMSO extension line clamp is opened and primed, open the
cover of Smart-Max and place the cryobag(s) on the platform(s) (Fig. 2). Pay
attention to properly place the tubing between the cryobag and the syringe in the
designated space.

Fig. 2

Check carefully that the bag(s) is in place and close the cover. Ensure proper locking
of the cover by pressing in the black knob placed on the left side (Fig.3).

Fig. 3

Install the syringe containing the cryoprotectant solution in the dedicated support: 10
ml syringes in the small holder, or 20 ml syringes in the large holder (Fig.4).

Fig. 4

Cryo-SC protocol OM – 2320 – 04 – 00 25

Install the connector of the FA-100.1 DMSO extension line in the designated holder,
ensuring proper connection (Fig. 4): this will prevent dislodging of syringe containing
cryoprotectant solution during functioning of the peristaltic pump.

Install the tubing of the FA-100.1 DMSO extension line around the circular pump
head, in the direction indicated in Fig. 5. Ensure no kinks or twists of the tubing occur
and then secure tubing around pump by closing the lever of the pump by rotating
forward.

Perform a visual check to ensure installation has properly occurred.

Fig. 5

4.3 Parameter selection

Press button, and the screen will display the protocol’s specific user
selectable parameters (Fig. 6).

Fig. 6

Cryo-SC protocol OM – 2320 – 04 – 00 26

Cooling time

Time for cooling the cryobag(s), before starting cryoprotectant solution addition.
Adjustable value between 0 to 20 minutes. If the cryobag(s) has already been cooled
in a fridge, enter 0 to start injection of cryoprotectant solution immediately.
Default value is 10 minutes.

Injection time

Desired time for injecting cryoprotectant solution. Adjustable parameter between 0 to
20 minutes. Recommended value is 12 minutes.

Volume to inject

Volume of cryoprotectant solution to be added to the cryobag(s). Recommended
value is 5 ml.

Once the desired values have been entered, the corresponding flow rate for injection
will be calculated and compared with the device’s limit.

The maximum flow rate possible with the FA-100.1 DMSO extension line is 0.9
ml/min (higher value will not be accepted by the device).

In case of parallel procedures for two cryobags, the same parameters will be
applied to both units. Please install the first unit and keep the cover closed
until the second unit is ready. When the second unit is ready for cryoprotectant
addition, open the cover, install the cryobag, complete the traceability
information, close the cover and launch the automated procedure.

Press the button: if the traceability option is enabled, you’ll be able to insert
the corresponding values; if the traceability option is not enabled, it will start the
automated procedure.

4.4 Traceability function and launching of the automated procedure

If the traceability option of Smart-Max is enabled, the following screen is displayed
(Fig. 7)

Fig. 7

Cryo-SC protocol OM – 2320 – 04 – 00 27

Press on , and you can configure the list of ID’s by selecting those that
you want to insert.
When a specific ID is highlighted, enter the corresponding value using the barcode

reader or displayed keyboard, then press .
Ensure proper locking of the cover by pressing in the black knob placed on the left

side (Fig. 3).

In case some of the traceability ID’s have already been inserted, please check the

exactitude of the values, eventually complete the information and start the automated
procedure.

4.5 Starting of the procedure

Press the button, and the screen will display a list of important points to be
verified prior to start of the automated procedure (Fig. 8):

Fig. 8

Ensure all requirements on the list have been verified, and press to begin
the protocol.

During the automated procedure, the display screen reports relevant information for
the procedure (Fig. 9 & 10).

Cryo-SC protocol OM – 2320 – 04 – 00 28

Fig. 9

Fig. 10

4.6 Post procedure actions

When the procedure is completed, the following screens are displayed (Fig. 11 & 12):
Before removing the cryobag, remember to close the clamp on the FA-100.1

extension line to avoid unexpected injection of additional solution inside the bag.

Cryo-SC protocol OM – 2320 – 04 – 00 29

Fig. 11

Fig. 12

Open the cover by pressing in the black knob on the right side of the cover (Fig. 13),
and remove the bag(s). Opening of the cover will automatically terminate the
procedure and Smart-Max will return to the starting page of the protocol.

Cryo-SC protocol OM – 2320 – 04 – 00 30

Fig. 13

Prepare the cryobag(s) for freezing following your own validated procedure.

4.7 Troubleshooting

In case of any error or procedure interruption, a message will appear on the display
(Fig. 14).

Fig. 14

After pressing , the Smart-Max automatically displays the main menu.
For a description of possible errors and corrective actions, please refer to section 3.4
of the Operator’s Manual.
After following the actions reported in the table, you can re-load protocol Cryo-SC to
complete the aborted procedure.

Due to the cord blood unit being in contact with cryoprotectant solution,
troubleshooting actions must be performed as quickly as possible and
validated by the laboratory manager.

Cryo-SC protocol OM – 2320 – 04 – 00 31

new Procedure time = new Volume

Initial Volume

Initial time

= 2.5

*

*

12

5

= 6 mins

Before launching the new procedure, all protocol parameters must be checked and
adapted:

Cooling time

In case the interruption occurred during the pre-cooling phase, restart the procedure
and set the parameter at the same value.
In case this phase has already occurred, set the parameter to 0: this will allow
injection to start immediately.

Volume to inject

In case injection of cryoprotectant solution had begun, reduce this value by the
quantity of solution already injected into the cryobag (excluding the volume used for
priming the DMSO extension line).
For example, if the total volume of cryoprotectant in the syringe was 6.5 ml (after
priming) at the start of the procedure, and the syringe contained 4 ml at the moment
of interruption, and the desired volume to inject into the bag is 5ml, the Volume to
add should be set at 5 – (6.5 – 4) = 2.5 ml.
In case the injection of cryoprotectant solution had NOT yet started, set the
parameter at the same value.

Injection time

The value of the parameter must be adapted corresponding to the Volume of
cryoprotectant solution still to be added.
In the previous example Volume to add is now set at 2.5 ml, therefore the new
Procedure time must be set at:

If the parameters have been adapted correctly, the flow rate displayed should be
equal to that of the initial procedure.

Press the button, verify the points listed and the correct installation of the
syringe and the DMSO extension line and then start the automated procedure.

Cryo-SC protocol OM – 2320 – 04 – 00 32

5. Maintenance

As with any electrical equipment, fluid entering the Smart-Max can

adversely affect its performance. Do not attempt to clean any internal

parts of the Smart-Max – this should only be done by a Biosafe

approved technician. If in doubt, contact Biosafe for advice.

Any other maintenance or technical intervention should only

be performed by Biosafe approved technicians.

The Smart-Max is designed to require minimal maintenance.
The only maintenance the operator must perform consists of cleaning the outer
surfaces of the Smart-Max and the associated power cables.

The Smart-Max equipment should be serviced every 1000 procedures or, at a
minimum, once per year. The elements that require servicing by the Biosafe
approved technician are described in the Service Manual.

4.1 Cleaning

The Smart-Max should be cleaned on a regular basis or after any incident such as
product leakage.
The following procedure should be used for cleaning:

1. Switch off the Smart-Max before beginning the cleaning procedure to prevent
risk of electrical shock.

2. Rubber gloves and a protective gown should be worn to prevent direct skin
contact with any spilled cord blood during the cleaning procedure.

3. With gauze bandage or a soft paper soaked with warm water clean the blood
off the surface. Dry the damp surface with soft paper and repeat as necessary
to ensure the surface is clean.

4. Use an antibacterial solution to disinfect the surface - such as Meliseptol®.

4.2 Waste management

This product is subject to Directive 2002/96/EC of the European
Parliament and the Council of the European Union on waste electrical
and electronic equipment (WEEE) and, in jurisdictions adopting that
Directive, is marked as being put on the market after August 13, 2005,
and should not be disposed of as unsorted municipal waste. Please
utilize your local WEEE collection facilities in the disposition of this
product and otherwise observe all applicable requirements.

Maintenance OM – 2320 – 05 – 00 33

4.3 Warranty

Biosafe products are designed and manufactured to provide reliable, trouble free
performance when properly maintained and used in accordance with the Operator’s
Manual.
Biosafe warrants to the original purchaser that the unit has been fully tested and
delivered according internal Biosafe procedures. Maintenance service and, if
required, repairs are free of charge for one year from the date of shipment.
Equipment failure due to reasons other than manufacturing defects such as
accidents, misuse or failure to perform scheduled maintenance is excluded from
warranty coverage.

Maintenance OM – 2320 – 05 – 00 34

6. Contacts

Biosafe SA

Route du Petit-Eysins 1

Telephone: [phone]

1262 Eysins, VD

Fax: [phone]

Switzerland

E-mail: [e-mail]

www.biosafe.ch

Support

Telephone: [phone]

E-mail: [e-mail]

Biosafe America, Inc.

1225 North Loop West

Telephone: [phone]

Suite 120

Fax: [phone]

Houston, TX 77008

E-mail: [e-mail]

USA

www.biosafeamerica.com

Support

Telephone: [phone]

E-mail: [e-mail]

Biosafe Asia-Pacific Ltd.

Room 3012, 30/F

Telephone: [phone]

Tower 1, The Gateway

Fax: [phone]

25 Canton Road

E-mail: [e-mail]

Tsim Sha Tsui, Kowloon

Hong Kong

www.biosafeasiapacific.com

Support

E-mail: [e-mail]

Biosafe Medical Device
International Trading (Shanghai)
Co. Ltd

Rm 80, 38F, Park Place No.1601

Telephone: [phone]
Fax: [phone]

Nanjing West Road

E-mail: [e-mail]

Shanghai 200040

China

www.biosafechina.com

Support

E-mail: [e-mail]

Biosafe Latin America

Av. Chedid Jafet, 222 – 5th floor

Telephone: [phone]
Fax: [phone]

Block D – Vila Olimpia

E-mail: [e-mail]

04551-065 Sâo Paulo

Brazil

www.biosafelatinamerica.com

Support

E-mail: [e-mail]

Contacts OM – 2320 – 06 – 00 35

Local representative (if applicable)

Contacts OM – 2320 – 06 – 00 36