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

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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.

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