SAHARA -TSC series instructions for Use

INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

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Safety advice ! ! ! ! !

! ! ! ! ! ! !

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Read all sections of these instructions for use carefully. Note the information given in the service manual. Keep these instructions in a place easily accessible to all users. The device may only be operated by trained medical personnel. Install and connect the device in accordance with these instructions. Before operation examine the device for evidence of damage. If you notice any damage or malfunction that might affect the safety of the device it must not be used. Always use the device as directed in these instructions. If the device has to be opened during cleaning or servicing, it must be turned off and disconnected from the local power supply system. Only use warming plates and agitator mechanism with the same color coding. During operation, neither the preparation nor the device must be connected to the patient. Do not tilt the warming plate by hand. Do not insert any objects through the blower covers or into the agitator mechanism. Do not pour or spray any liquids in the blower or the agitator mechanism.

Symbol description Important information. If ignored an operating error, malfunction or defect may occur.

Helpful information on the appropriate use of the device. Operating instruction.

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After unpacking Immediately upon receipt check the packing 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.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system 4

Scope of supply SAHARA-TSC and SAHARA-TSC 115V each consist of: the SAHARA-TSC platform including the warming plate a warming shell a mains cable these instructions for use and a service manual The module Protocol printer is not part of the delivery scope of SAHARA-TSC or SAHARA-TSC 115V respectively. It must be ordered separately (see Chapter 15). The use of the module Protocol printer is necessary if the temperature of the stem cell preparations shall be displayed and documented during the thawing process, or if the system test or occurring errors shall be recorded. The SAHARA-TSC system consists of: a SAHARA-TSC a SAHARA-III basic model a module Protocol printer a SAHARA module cart including the connecting mains cable to operate the 3 devices mentioned above via the SAHARA module cart a packaging unit of adaptation compresses

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Device description The dry-tempering device SAHARA-TSC allows a fast and temperature-controlled thawing of cryo-preserved blood stem cell preparations of volumes between 60 ml and 120 ml. Immediately prior to the transfusion, the cryo-preserved stem cell preparations are thawed separately between a pre-warmed adaptation compress and an equally prewarmed aluminium warming shell, employing the „sandwich method“. Thus, the temperature of each stem cell preparation bag is measured continuously via an infrared sensor which is placed directly on the surface of the preparation. To achieve an almost homogeneous temperature profile within the stem cell preparation it is permanently agitated. During the thawing process the adaptation compress serves as a passive heat reservoir which cools off 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 stem cell preparation, a visual and audible signal is output, and the energy supply via the warming plate is reduced to decelerate the further warming of the stem cell preparation. By means of the SAHARA-TSC system, other blood components than stem cell preparations can be thawed or warmed prior to transfusion, too.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

Features: Safe tempering method Contamination risks by water-borne pathogens as associated with water baths are prevented. Temperatures of the warming shell and the adaptation compress are controlled to ensure that the contact temperature of the stem cell preparation does not exceed a maximum of 37°C. Standardised thawing process. Delayed key reaction prevents an unintentional abort of the thawing process. Leaking stem cells from defective bags are recovered within the warming shell. Easy operation A pre-setting of the tempering times and of the ambient temperature is not necessary. Bag agitation Gentle agitation to achieve an almost homogeneous temperature profile 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. Fast availability of the stem cell preparations due to visual and audible free of ice indication. Display of the degree of tempering of the adaptation compresses. Integrated system test Check of the device functions. Calibration of the temperature sensors. Additional measuring apparatus is not necessary. Protocol printer Display and documentation of the measured preparation temperature. Documentation of errors Documentation of the integrated system test

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system Easy cleaning Warming shell, warming plate and adaptation compresses can be withdrawn separately and can easily be cleaned and disinfected. Hygienic thawing conditions Easy to clean and disinfect warming shell which can even be autoclaved to receive the stem cell preparation during thawing.

PREWARM key

SAHARA-TSC keypad START key

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FREE OF ICE LED LED 1... LED 9

PRE WARM

Display of the degree of warming for tempering forpre-warming pre-warmingof the adaptation compresses adaptation compresses

TEST

Figure 1: Keypad of SAHARA-TSC

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LED LED temperature temperature alarm alarm

100%

LED ERROR

STOP key

LED „Heating

LED POWER

STOP

TEST key

START

Installation and starting 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.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

SAHARA-TSC should not be connected to sockets supplying other systems such as photocopiers, refrigerators etc. 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. Warming plate and agitator mechanism must always have the same color code. 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 device automatically enters the standby mode. The device functions should be checked by means of the system test before the initial operation and after repair works (see Chapter 12.1). 7.2

Module Protocol printer

Turn off 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. For more detailed information please see the separate instructions for use of the protocol printer, which are enclosed in the module. 7.3

SAHARA-TSC system

Place the SAHARA module cart away from sources of heat and humidity. Place SAHARA-TSC, SAHARA-III basic model and the module Protocol printer on the SAHARA-module cart. Connect SAHARA-TSC, SAHARA-III basic model and the module Protocol printer to the SAHARA-module cart, using the delivered connecting mains cables.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

Connect the mains plug of the module cart to the local power supply. The SAHARA module cart should not be connected to sockets supplying other systems such as photocopiers, refrigerators etc. Connect the coding plug of the SAHARA-TSC warming plate to the socket at the rear of the SAHARA-TSC agitator mechanism. Locate the four pins on the underside of the warming plate on the agitator mechanism and push to secure into position. Connect the coding plug of the SAHARA-III warming plate to the socket at the rear of the SAHARA-III agitator mechanism. Locate the four pins on the underside of the warming plate on the agitator mechanism and push to secure into position. Warming plate and the corresponding agitator mechanism must always have the same color code. Connect the data cable of the module Protocol printer to the serial interface at the rear of SAHARA-TSC. Set the warming shell onto the SAHAHRA-TSC warming plate so that the grooves in the shell are on the left side. Turn on SAHARA-TSC, SAHARA-III basic module and the module Protocol printer at the power switch. Turn on the SAHARA module cart at the power switch. All devices automatically enter the standby mode. The device functions of SAHARA-TSC and SAHARA-III basic model should be checked by means of the system test before the initial operation or after repair works (see Chapter 12.1 and SAHARA-III operating instructions).

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Standby mode After switching on the device, after aborting the pre-warm or thawing process as well as after a passed 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 PREWARM key.

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Pre-warming of the adaptation compresses Prior to thawing cryo-preserved stem cell preparations, one adaptation compress per preparation has to be pre-warmed to between 37°C and 40 C. For pre-warming, SA-

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

HARA-TSC, 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 prewarming, the adaptation compresses must remain within the device for at least 30 minutes to grant a complete warming of the compresses. A non-observance of this hint may cause prolonged thawing times. 9.1

Pre-warming by means of SAHARA-TSC

Clean and disinfect the adaptation compresses as described in the package insert. Open the system flap and lay the required number of up to 5 adaptation compresses in the warming shell as described in Figure 2. Place the infrared sensor completely on the compress below.

Infrared sensor Adaptation compress Adaptionskompressen

Warming shell Figure 2: Pre-warming of adaptation compresses in SAHARA-TSC

Close the system flap and press the PREWARM key. The LED of the PREWARM key lights up. This shows the activation of the pre-warm function. Start pre-warming by pressing the START key. About 30 sec. after pressing the START key the blower starts tempering the adaptation compresses loaded 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%.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system Do not remove the adaptation compresses from the SAHARA-TSC before a warming degree of 100% is reached because this could lead to an incomplete warming of the adaptation compresses. Immediately before starting the thawing process of the stem cell preparations, abort the pre-warming by pressing the STOP key. Open the system flap 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 15) to prevent them from cooling. After the pre-warming, the function for thawing blood stem cells is automatically activated. This is indicated by the LED in the PREWARM key going out. 9.2

Pre-warming by means of SAHARA-III basic model

Clean and disinfect the adaptation compresses as described in the package insert. Open the system flap and place the adaptation compresses on the warming plate as described in Chapter 9.1. Close the system flap and start the pre-warming within the 37°C function by pressing the START key. The adaptation compresses must remain in the SAHARA-III basic model for at least 30 minutes. 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 flap 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 flap. Upon removing the last adaptation compress from the SAHARA-III basic model, abort the pre-warming process by pressing the STOP key. With regard to the use of SAHARA-III basic model for thawing and warming blood components please see the separate instructions for use.

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Thawing of cryo-preserved blood stem cell preparations 10.1 Infrared sensor The mobile probe that is fixed at the arm of the warming plate is an infrared sensor, monitoring a circular area of about 7 cm². During thawing the infrared sensor is used to

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

measure the temperature of the stem cell preparation that is placed within this circular area. To achieve a correct temperature measurement all additional wrappings have to be removed from the preparation (e.g. bonded plastic sheeting) before starting the tempering process, and there must be no detached labels or loose tubes within the area of the scanned preparation surface. In cases where additional wrappings cannot be removed, a correct measurement can only be attained for preparations with transparent and tight fit wrapping. 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 stem cell preparation from the deep freezer immediately before the beginning of thawing. Carefully take the stem cell preparation out of the storage box. Preferably, remove all extra wrappings (e.g. bonded plastic sheeting) or use stem cell preparations with transparent and tight fit wrapping. This reduces the tempering time and allows a more precise measurement of the preparation temperature. Lay the stem cell preparation left-justified 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 stem cell preparation with a pre-warmed adaptation compress so that the hole in the adaptation compress is completely placed on the stem cell preparation (cf. Fig. 3 and 4). In order to reduce the thawing time you can also place two adaptation compresses, stacked one upon the other, on the stem cell preparation. The stem cell preparation is warmed via the pre-warmed adaptation compress as well as via the warming shell. Infrared sensor Stem cell preparation

Adaptation compress

Adaptation compress Warming shell

Stem cell preparation

Warming shell Infrared sensor

Fig. 3 and 4: Setup of the thawing configuration

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

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 stem cell preparation. At locating the infrared sensor, pay attention to the fact that the infrared sensor must entirely bear on the stem cell preparation and must not partly cover the adaptation compress. Start the thawing process by pressing the START key. Leave the system flap open and carefully observe the thawing process. While the adaptation compress cools off 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 stem cell preparation is continuously output via the protocol printer. If the frozen stem cell preparation is almost free of ice the FREE OF ICE-LED will start flashing and a recurrent audible signal will resound. The free of ice state is indicated by a permanent illumination of the FREE OF ICE-LED as well as a recurrent audible twotone 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 stem cell preparation. As the FREE OF ICE-LED starts flashing, check the viscosity of the stem cell preparation by hand (cf. Fig. 5 and 6). Terminate the thawing process by pressing the STOP key at the desired viscosity or temperature and remove the stem cell preparation from the SAHARA-TSC. A control of the stem cell preparation temperature during the thawing process is only possible when using the module Protocol printer. If possible, the stem cell preparation should be transfused immediately after the thawing process.

Fig. 5 and 6: Sensory and visual check of the preparation viscosity

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

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Error messages and trouble shooting In case of a system failure the SAHARA-TSC issues an error message by illuminating the ERROR LED and the FREE OF ICE-LED or the LEDs of the degree of tempering respectively. Furthermore, a permanent audible alarm signal resounds. If the module Protocol printer is connected the error will be documented in the printout. After the error message the device is disabled for further use and can only be re-started by turning off and on at the power switch. The device must not be used for the thawing of cryopreserved blood stem cell preparations or for the pre-warming of adaptation compresses until the error has been eliminated. The audible alarm signal during an error messages can be deactivated for 2 minutes by pressing the STOP key. If an error message is output during the thawing process, the temperature of the stem cell preparation must be measured immediately after its removal from the device. This can be done easily and reliably by means of a calibrated thermometer: Simply fold the bag along its length and place the thermometer in the hollow. If the thermometer reads an unacceptably high temperature the stem cell preparation may become useless for transfusion purposes. Please, in any case, contact the responsible physician! The following table assists you in identifying the cause of an error and remedy it. If more than one measure appears to be suitable in remedying a particular error, then each measure must be implemented one after the other. If the measures listed in the table do not eliminate the error please notify the after-sales service (see Chapter 13). Control the success of every single measure by initiating the system test. For this, the device must be turned off and on at the power switch. Please note also the information in Chapter 12.1.

Cause: Error message

Measure(s):

ERROR + FREE OF ICE ERROR + LED 1

Clean the optics of the infrared sensor with as little glass cleaner as possible and dry it afterwards.

Infrared sensor soiled or defect

Turn off SAHARA-TSC at the power switch. Completely inWrong or missing cod- sert the coding plug of the warming plate into the socket of the agitator mechanism. Turn on SAHARA-TSC again. ing plug

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system ERROR Overtemper- 1. Check if a stem cell preparation is lying within the scanning area of the infrared sensor. If this is not the case, + ing possible switch off and on again the SAHARA-TSC. Place a cryoLED 2 preserved stem cell preparation under the infrared sen+ sor and start a new tempering process. Tempera2. Check whether the infrared sensor is lying completely on ture the stem cell preparation and does not partly cover the alarm adaptation compress. The scanned surface of the stem cell preparation must not show any protruding objects (no additional packaging, detached labels etc.). Remove those objects and start a new tempering process. ERROR Warming Make sure that the coding plug of the warming plate is inplate sensor serted completely into the socket of the agitator mechanism. + If necessary, loose the plug and push it in one more time. LED 3 defect ERROR + LED 5

Warming shell not removed during system test or blower defect

ERROR + LED 7

1. Remove the warming shell from the warming plate during Warming the system test. shell not removed 2. Cool the device down to room temperature by leaving the during the system flap open. system test 3. Make sure that the coding plug of the warming plate is or warming inserted completely into the socket of the agitator mechplate heating anism. If necessary, loose the plug and push it in one element demore time. fect

ERROR + LED 8

No commu- Make sure that the coding plug of the warming plate is innication with serted completely into the socket of the agitator mechanism. If necessary, loose the plug and push it in one more time. warming plate or ambient air temperature sensor

ERROR + LED 9

No commu- Make sure that the coding plug of the warming plate is innication with serted completely into the socket of the agitator mechanism. infrared sen- If necessary, loose the plug and push it in one more time. sor

1. Remove the warming shell from the warming plate during the system test. 2. Cool the device down to room temperature by leaving the system flap open.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

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Maintenance of SAHARA-TSC 12.1 System test By means of the integrated system test the device functions including the electromechanical components and temperature sensors are checked in 10 steps. The first and second test step check the operation of the LEDs and of the agitator mechanism. This has to be observed by the user. The following test steps are performed automatically. The conclusion of each test step is indicated by a short audible signal and the illumination of an LED of the degree of tempering display. The system test takes about 30 – 40 min. If a malfunction is observed by the user during the first and second test step then SAHARA-TSC should be locked from usage and the after-sales service must be contacted. If a system error is detected during the following test steps, then the system test will be automatically aborted and an error code is displayed in the FREE OF ICE LED or in the LEDs of the degree of tempering display, as well as in the printout of the protocol printer if the corresponding module is connected. An explanation of the different error codes as well as the appropriate measures are given in chapter 11. Turn off SAHARA-TSC at the power switch. Remove the warming shell from the warming plate and thoroughly clean the warming plate. Locate the infrared sensor on the warming plate. Turn on SAHARA-TSC at the power switch and operate it in standby mode for about 15 min. Press the TEST key. Step 1: All LEDs of the keypad light up simultaneously for about 5 sec. Check the function of the LEDs. Step 2: The agitator mechanism starts a recurrent movement of the warming plate. Check if the warming plate recurrently tilts to the front and to the back. Steps 3 to 10: Keep the system flap closed for the following test steps. The steps 3 to 10 are performed automatically. After a passed system test the SAHARA-TSC automatically enters the standby mode.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

Lift the infrared sensor and arrest it in the top position. The device functions should always be checked if the device is started for the first time or after repair works. In any case, a check of the device functions must be performed at least every 3 months. 12.2 Cleaning To prepare the SAHARA-TSC for cleaning, the upper housing, the warming shell and the warming plate must first be removed. All the subsystems in the interior are now freely accessible and can easily be cleaned. Furthermore, the upper housing can be cleaned thoroughly at a more suitable site. Turn off the device at the power switch and disconnect it from the local power supply system. Open the toggle-type fastener on the system’s rear panel and lift the back of the upper housing by about 2 cm. Keeping the upper housing at this angle, push it to the front by about 2 cm. Lift and remove it. Remove the warming shell from the warming plate. Pull the warming plate out of its plug-in connection and remove the coding plug from the agitator mechanism. Do not tilt the warming plate by hand! Both alcohol- and formaldehyde-based agents may be used to clean or disinfect the system. In all cases, cleaning by wiping should be preferred to spray cleaning. If need be, the warming shell can also be sterilised in an autoclave. For cleaning the adaptation compresses, please see the enclosed instructions for use. Do not use sharp-edged or sharp objects or scouring agents for cleaning SAHARA-TSC. Keep liquids away from the blower and the agitator mechanism.

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After-sales service and transport If you have questions regarding the device, please contact the sales agency assigned to your organisation. Please make a note of the serial number of the device and specify the error in case of a malfunction. If the device has to be shipped for repair, servicing or testing, please pack it properly to prevent any transit damage. For this we strongly recommend the use of the original packaging or a transport case authorized by the manufacturer or your sales agency. The manufacturer will assume no responsibility for damage incurring during transport caused by improper packaging. Any carriage charges for the return of the device must be paid by the customer.

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system

The manufacturer reserves the right to make improvements and modifications to the device which lead to a technical enhancement.

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Technical Data Sizes:

W H D: 320 325 493 (measured in mm)

Weight:

14,3 kg

Rated Voltage (±10 %):

SAHARA-TSC:

230 V AC

SAHARA-TSC 115V: 115 V AC Frequency:

50-60 Hz

Rated power, current consumption:

SAHARA-TSC:

550 W, 2,4 A

SAHARA-TSC 115V: 550 W, 4,8 A Accuracy of infrared sensor:

Max. ± 1,5°C at 0°C

Ambient conditions:

5 - 30 °C max. 85 % rel. air humidity

Protection class:

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I

Accessories Product

Product code

SAHARA-III basic model Pre-warming of adaptation compresses, mains power 230 V

97.8710.500

SAHARA-III basic model 115V Pre-warming of adaptation compresses, mains power 115 V Transport case SAHARA-III Secure transport of SAHARA-TSC and SAHARA-III SAHARA module cart for 2 devices, vertical Allows the mobile use of 2 SAHARA devices aligned one above the other. Central power supply, pull-out work surfaces, four steerable costors and a spacious drawer. SAHARA module cart for 1 device Allows the mobile use of 1 SAHARA device. Central power supply, pull-out work surfaces, four steerable costors and a spacious drawer. SAHARA module cart for 2 devices, horizontal Allows the mobile use of 2 SAHARA devices aligned side by side. Central power supply, pull-out work surfaces, four steerable costors and a spacious drawer.

Module Protocol printer

97.8710.502 97.8710.505

97.8710.520

97.8710.521

97.8710.522

97.8710.570

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INSTRUCTIONS FOR USE SAHARA-TSC and SAHARA-TSC system Documentation of the tempering process, the system test and occurring errors

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Protocol printer paper Spare paper roll for the module Protocol printer

79.8710.575

Ink ribbon protocol printer Spare ink ribbon for the module Protocol printer

79.8710.576

Adaptation compress TSC Adaptation compress for thawing stem cell preparations, SU=5 pieces

97.8710.610

X° Control Mono Box Insulating box to keep adaptation compresses warm

97.8750.140

Declaration of conformity Due to the EC Council Directive MDD 93/42/EEC, appendix IX the dry-tempering devices SAHARA-TSC and SAHARA-TSC 115V are medical electrical products of class IIa. The following harmonized standards are applicable to the devices: EN 60601-1:1996, EN 60601-1-2:1993, EN 55011:1991, EN 61010-1:1993+A2:1995 and EN 61010-2-010:1994+A1:1996. The company TRANSMED Medizintechnik GmbH & Co. KG is manufacturer according to the EC Council Directive MDD 93/42/EEC. Because TRANSMED has implemented an assessment of conformity to MDD 93/42/EEC they are allowed to label the device with the EC mark

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Warranty If there are no other prearrangements in the contract of sales, the device comes with the legal warranty. This warranty applies to the replacement or repair, free of charge, of any components which the manufacturer has found to be defective and which have not been modified without authorization, misused, or misapplied. The manufacturer sees itself responsible for the safety, reliability, and effectiveness of the device only when checkups, installation, expansions, readjustments, modifications, and repairs have been conducted by persons authorized by the manufacturer and when the device is being used in full compliance with these instructions for use.

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