Sarstedt SAHARA-TSC User manual

Instructions for use SAHARA-TSC
Instructions for Use
SAHARA-TSC
SAHARA-TSC 115V

2
Instructions for use SAHARA-TSC
Basic notes!
Last modied: August 2023
Manufacturer and
customer service address:
Device data:
(to be completed by the customer)
SARSTEDT AG & Co. KG
Sarstedtstr. 1
51588 Nümbrecht
Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
www.sarstedt.com
Type: SAHARA-TSC
Serial No.:
Place of installation:
Issue date:
Inventory No.:
Please keep the Instructions for Use as a reference for
information on your device.
Copyright:
SARSTEDT AG & Co. KG is the copyright holder of these Instructions for Use.
The Instructions for Use are intended only for the operating personnel and for the purchaser of the
device. These Instructions for Use may not be reproduced or distributed in whole or in part without the
written consent of SARSTEDT AG & Co. KG. Violations can have criminal consequences.
Technical modications reserved!
Nümbrecht, August 2023
SARSTEDT AG & Co. KG

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Instructions for use SAHARA-TSC
Table of Contents
Basic notes! ......................................................................................................................................................2
1 Safety information..................................................................................................................................4
2 Explanation of symbols and instructions .............................................................................................4
3 After unpacking ......................................................................................................................................6
4 Scope of delivery ...................................................................................................................................6
5 Indication for use and function..............................................................................................................6
6 SAHARA-TSC membrane keypad..........................................................................................................7
7 Installation and commissioning.............................................................................................................7
7.1 SAHARA-TSC...........................................................................................................................................7
7.2 Protocol printer module ............................................................................................................................8
8 Standby mode ........................................................................................................................................8
9 Pre-warming of the adaptation compresses ........................................................................................8
9.1 Pre-warming using SAHARA-TSC.............................................................................................................8
9.2 Pre-warming using SAHARA-III basic model.............................................................................................9
10 Thawing of cryopreserved leukapheresis products from mobilised donors.....................................10
10.1 Infrared sensor .......................................................................................................................................10
10.2 Thawing .................................................................................................................................................10
11 Error messages and troubleshooting..................................................................................................11
12 SAHARA-TSC service and maintenance .............................................................................................12
12.1 System test ............................................................................................................................................12
12.2 Cleaning.................................................................................................................................................13
13 Decommissioning and disposal .......................................................................................................... 14
14 Servicing and transport .......................................................................................................................14
15 Technical Data SAHARA-TSC ..............................................................................................................14
16 Accessories ..........................................................................................................................................15
17 Warranty and guarantee.......................................................................................................................15

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Instructions for use SAHARA-TSC
1 Safety information
• Please note the information in the service manual.
• The device may only be operated by trained medical personnel.
• The device may only be installed and operated in areas of professional health care facilities with no strong electromagnetic
interference elds. Portable RF communication equipment may aect the device functions and should therefore not be
used at a distance less than 30 cm from parts and cables of the device.
Operate the device only with the mains cable supplied. Using a mains cable other than the original cable supplied may
lead to a higher electromagnetic emission or reduced electromagnetic immunity of the device and result in a malfunction.
This device should not be operated directly beside or stacked with other devices, since this may lead to a malfunction.
If this is however necessary, the devices should be observed with respect to their correct operation.
• To prevent the risk of electric shock, the device must only be connected to a mains supply with a protective earth
connection.
• Check the device for visible signs of damage before switching on. If you notice any safety relevant damage the device
must not be used.
• If the device should be connected to an IT network, the integration of IT devices other than those specied in Chapter 16,
changes to the IT network conguration, additional connection or removal of IT devices, and a software update on the IT
devices used can lead to risks for patients, operators or third parties that were previously unknown. These risks should be
analysed and assessed by the operator.
• To remove leaked liquids do not tilt the device.
• To avoid possible crushing of ngers install and remove the agitation plate only when the device has been turned o.
• If the device has to be opened during cleaning or servicing, it must be turned o and disconnected from the local power
supply by unplugging the mains cable since some device parts are under voltage even when the device has been
turned o.
• The device must not be used within the patient environment.
• The leukapheresis product within the device must not be connected to the patient.
• During an on-going tempering process the leukapheresis product must not be removed from the device.
• Do not modify this equipment without authorization of the manufacturer.
• Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent
national authority in which the user is established.
2 Explanation of symbols and instructions
Follow instructions for use
WARNING
Important information. If ignored a serious or life-threatening injury may occur.
WARNING
Important information. If ignored an electrical shock due to dangerous voltage may occur.
CAUTION
Important information. If ignored a minor injury may occur.
CAUTION
Helpful information on the appropriate use of the device. If ignored an operating error,
malfunction or device defect may occur
Permissible pressure range

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Instructions for use SAHARA-TSC
Permissible temperature range
Store in a dry place
Article number
Serial number
CE mark
Medical device
Manufacturer
Country of manufacture
Manufacturing date
Unique product identication
Separate collection of electrical and electronic equipment
Alternating current

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Instructions for use SAHARA-TSC
3 After unpacking
Immediately upon receipt check the packaging and the device for damage and completeness in accordance with chapter 4.
If you notice any damage caused during transit then please notify the responsible transport company and the sales agency
assigned to your organisation without delay.
Retain the entire packaging in a safe place as evidence for any claim and if required for the return of the device.
4 Scope of delivery
SAHARA-TSC and SAHARA-TSC 115V each consist of:
• the SAHARA-TSC platform including the warming plate
• a warming shell
• the adaptation compress TSC (5 pieces)
• a mains cable
• these instructions for use and
• a service manual
The protocol printer module is not in the scope of delivery of the SAHARA-TSC or SAHARA-TSC 115V
respectively. It must be ordered separately (see Section 16). The use of the protocol printer module is
necessary if the temperature of the leukapheresis products is to be displayed and documented during the
thawing process, or if the system test or occurring errors are to be recorded.
5 Indication for use and function
The dry tempering device SAHARA-TSC allows a fast and temperature-controlled thawing of cryopreserved products
from mobilised donors (therein referred to as leukapheresis products). SAHARA-TSC has been successfully tested using
cryopreserved leukapheresis products from mobilised donors with volumes ranging from 60 ml to 120 ml.
Immediately prior to the transfusion, the cryo-preserved leukapheresis products are thawed separately between a pre-
warmed adaptation compress and an equally pre-warmed aluminium warming shell, employing the “sandwich method”.
Thus, the temperature of each leukapheresis product bag is measured continuously via an infrared sensor which is placed
directly on the surface of the preparation. To achieve an almost homogeneous temperature prole within the leukapheresis
product it is permanently agitated. During the thawing process the adaptation compress serves as a passive heat reservoir
which cools o whereas the temperature of the warming shell is controlled actively by an electrically heated warming plate.
If the infrared sensor detects a free of ice state of the leukapheresis product, a visual and audible signal is output, and the
energy supply via the warming plate is reduced to decelerate the further warming of the leukapheresis product.
Functions:
Safe tempering method
• Contamination risks by water-borne pathogens associated with water baths are prevented
• Temperatures of the warming shell and the adaptation compress are controlled to ensure leukapheresis product quality
that is at least equal to or even be better than using a water bath
• Standardised thawing process
• Delayed key reaction prevents unintentional aborting of the thawing process.
Simple operation
• No adjustment of tempering times and ambient temperatures required
Blood bag agitation
• Gentle agitation to achieve an almost homogeneous temperature prole within the bag and to prevent damage to
the stem cells.
Temperature monitoring
• Measurement of the preparation temperature by means of an infrared sensor.
• Documentation of the recorded preparation temperature by means of a protocol printer.

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Instructions for use SAHARA-TSC
• Fast availability of the leukapheresis products due to visual and audible free of ice indication.
• Display of the degree of tempering of the adaptation compresses.
Integrated system test
• Checking the device functions
• Calibration of temperature sensors
• Use of additional measuring equipment is not required
Protocol printer
• Display and documentation of the measured preparation temperature.
• Documentation of errors
• Documentation of the integrated system test
Easy cleaning
• Leaking stem cells from defective bags are collected in the warming shell and cannot reach the interior of the device
• Warming shell, warming plate and adaptation compresses can be taken out of the instrument separately and can easily be
cleaned and disinfected.
Hygienic thawing conditions
• Easy to clean and disinfect warming shell which can even be autoclaved prior to thawing the leukapheresis product.
6 SAHARA-TSC membrane keypad
Fig. 1: SAHARA-TSC membrane keypad
7 Installation and commissioning
7.1 SAHARA-TSC
• Install SAHARA-TSC away from sources of heat and humidity. The installation base must be horizontal and should not be
exposed to any vibration.
• Connect SAHARA-TSC via the supplied mains cable to the local power supply.
LED POWER
Display of the degree of
tempering for pre-warming
the adaptation compresses
LED ERROR LED temperature alarm STOP key TEST key Display “Heating on”
LED 1
START key
FREE OF ICE LED
LED 9 PREWARM key

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Instructions for use SAHARA-TSC
The device may be connected only to a power supply with protective earth conductor and has to be set
up so that the mains plug can be disconnected from the mains supply at any time.
• Connect the warming plate coding plug to the socket at the rear of the agitator mechanism. Locate the four pins on the
underside of the warming plate on the agitator mechanism and push to secure into position.
• Set the warming shell onto the warming plate so that the grooves in the shell are on the left side.
• Turn on SAHARA-TSC using the power switch. The system automatically enters the standby mode.
The device functions should be checked via system testing (see chapter 12.1) before initial operation
and after maintenance work.
7.2 Protocol printer module
• Turn o SAHARA-TSC at the power switch.
• Insert the mains cable into the power supply connector at the rear of the protocol printer and connect the mains plug to
the local power supply.
• Connect the protocol printer to the serial interface at the rear of SAHARA-TSC by means of the data cable.
• Turn on the protocol printer using the power switch at the rear of the device. The protocol printer automatically enters the
standby mode.
Please note further information in the separate instructions for use for the protocol printer that are
enclosed with the module.
8 Standby mode
After switching on the device, after aborting the pre-warm or thawing process as well as after passing a system test,
SAHARA-TSC automatically enters the standby mode. The warming plate is heated to 36 °C and the thawing function is
activated. This is indicated by the non-illuminated LED of the key.
9 Pre-warming of the adaptation compresses
Prior to thawing cryopreserved leukapheresis products, one adaptation compress per leukapheresis product must be
pre-warmed to between 37 °C and 40 °C. For pre-warming, the SAHARA-TSC, the SAHARA-III basic model or any other
appropriate dry-tempering system can be used.
When using the SAHARA-III basic model or another dry-tempering device for pre-warming, the
adaptation compresses must remain within the device for at least 30 minutes to achieve a complete
warming throughout. Non-observance of this may cause prolonged thawing times.
9.1 Pre-warming using SAHARA-TSC
• Clean and disinfect the adaptation compresses as described in the package insert.
• Open the system ap and lay the required number of up to 4 adaptation compresses in the warming shell as described
in Figure 2. Place the infrared sensor completely on the compress below.

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Instructions for use SAHARA-TSC
Figure 2: Pre-warming of adaptation compresses in SAHARA-TSC
• Close the system ap and operate the key.
The LED in the key lights up. This shows the activation of the pre-warm function.
• Start pre-warming by pressing the key.
Approx. 30 seconds after pressing the key, the blower starts tempering the adaptation compresses on the warming
shell by warming the ambient air within the device. Additionally, the adaptation compresses are tempered by the warming
plate. The progress of the pre-warming process is indicated by the display of the degree of tempering on the keypad.
• The adaptation compresses must remain within the SAHARA-TSC until the degree of tempering has reached 100 %.
Do not remove the adaptation compresses from the SAHARA-TSC before a 100 % degree of tempering
is reached as this could lead to an incomplete warming of the adaptation compresses.
• Immediately before starting the thawing process of the leukapheresis products, abort the pre-warming by pressing
the key.
• Open the system ap and place the adaptation compresses on a heat-insulated bench. Store the adaptation compresses
that are not needed immediately in a closed insulated box (see Chapter 16) to prevent them from cooling.
• After the pre-warming, the function for thawing leukapheresis products is automatically activated. This is indicated by
the LED in the key turning o.
9.2 Pre-warming using SAHARA-III basic model
• Clean and disinfect the adaptation compresses as described in the package insert.
• Open the system ap and place the adaptation compresses on the warming plate as described in Chapter 9.1.
• Close the system ap and start the pre-warming process in the 37 °C function by pressing the key.
• The adaptation compresses must remain in the SAHARA-III basic model for at least 30 minutes.
During the pre-warming process, the warming plate must not be removed from the device.
Do not abort the pre-warming process even if the device indicates a temperature of 37 °C because
this could lead to an incomplete warming of the adaptation compresses.
• Open the system ap and remove one adaptation compress for the planned thawing process.
Leave the remaining adaptation compresses in the SAHARA-III basic model and close the system ap.
• Upon removing the last adaptation compress from the SAHARA-III basic model, cancel the pre-warming process by
pressing the key.
Infrared sensor
Warming shell
Adaptation compress

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Instructions for use SAHARA-TSC
10 Thawing of cryopreserved leukapheresis products from mobilised donors
10.1 Infrared sensor
The mobile probe that is attached to the arm of the warming plate is an infrared sensor, monitoring a circular area of
approximately 7cm². During thawing the infrared sensor is used to measure the temperature of the leukapheresis product
that is placed within this circular area. To achieve a correct temperature measurement there must be no detached labels or
loose tubes within the area of the scanned preparation surface.
10.2 Thawing
• Remove the warming shell from the warming plate and put it on a heat-insulated bench.
• Take the storage box containing the leukapheresis product from the deep freezer immediately before the beginning
of thawing.
• Carefully take the leukapheresis product out of the storage box.
• Lay the leukapheresis product left-justied on the warming shell so that possibly existing bulges of the preparation
will lie within the grooves of the warming shell. The ports must be on the right side (cf. Fig. 3 and 4).
• Completely cover the leukapheresis product with a pre-warmed adaptation compress so that the hole in the adaptation
compress is completely over the leukapheresis product (see Fig. 3 and 4).
The leukapheresis product is warmed via the pre-warmed adaptation compress and warming shell.
Fig. 3 and 4: Setup of the thawing conguration
• Lay the loaded warming shell on the warming plate. Pass the infrared sensor through the hole in the adaptation compress
and place it directly on the leukapheresis product.
Upon locating the infrared sensor, note that the infrared sensor must be completely on the leukapheresis
product and may not partly cover the adaptation compress.
• Start the thawing process by pressing the key.
• Leave system ap open and observe the thawing process.
While the adaptation compress cools o during thawing, the temperature of the warming shell is controlled by the heated
warming plate. If the module Protocol printer is connected to the SAHARA-TSC the temperature of the leukapheresis
product is continuously output via the protocol printer.
During an ongoing tempering process, the warming plate and leukapheresis product must not be
removed from the device.
If the frozen leukapheresis product is almost free of ice the FREE OF ICE-LED will start ashing and a recurrent audible
signal will sound. The free of ice state is indicated by a permanent illumination of the FREE OF ICE-LED as well as
a recurrent audible two-tone signal. Upon detecting the free of ice state, the energy supply to the warming shell is
automatically reduced in order to decelerate the further warming of the leukapheresis product.
• As the FREE OF ICE-LED starts ashing, check the viscosity of the leukapheresis product by hand (cf. Fig. 5 and 6).
Terminate the thawing process by pressing the key at the desired viscosity or temperature and remove the
leukapheresis product from the SAHARA-TSC.
Infrared sensor
Infrared sensor
Stem cell preparation
Stem cell preparation Warming shell
Warming shell
Adaptation compress
Adaptation compress