SAHARA-III Instructions for Use Feb 2016

Instructions for Use

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Technical modifications reserved.

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Instructions for use SAHARA-III

Table of contents

Page

SAFETY ADVICE ... 2

SYMBOL DESCRIPTION... 2

AFTER UNPACKING ... 3

SCOPE OF SUPPLY ... 3

DEVICE DESCRIPTION... 3

KEY PAD ... 5

STARTING ... 5 7.1 7.2 7.3 7.4

MODULE WARMING PLATE ... 5 MODULE MAXITHERM ... 6 MODULE INFUSION WARMER ... 6 MODULE PROTOCOL PRINTER ... 6

THAWING AND WARMING OF BLOOD COMPONENTS ... 7 8.1 8.2 8.3 8.4

INFRARED SENSOR ... 7 POSITIONING OF BLOOD BAGS ... 7 FAST TEMPERING FUNCTION... 7 37 °C FUNCTION ... 9

INFUSION WARMING ... 9

STANDBY MODE ... 10

ERROR MESSAGES AND TROUBLE SHOOTING ... 10

SERVICE AND MAINTENANCE ... 12

12.1 SYSTEM TEST... 12 12.2 CLEANING ... 13 NP

PUTTING OUT OF OPERATION AND DISPOSAL ... 13

AFTER-SALES SERVICE AND TRANSPORT ... 13

TECHNICAL DATA ... 14

ACCESSORIES ... 14

DECLARATION OF CONFORMITY ... 15

WARRANTY AND GUARANTEE ... 15

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Instructions for use SAHARA-III

Safety advice ►

Please note the information in the service manual and “EMC advice”.

►

The device may only be operated by trained medical personnel.

►

This device is subject to special precautions with regard to the electromagnetic compatibility (EMC) and has to be installed and put into operation acc. to the enclosed EMC advice. Portable and mobile HF communication equipment may affect the device functions.

►

Using a mains cable instead of the original one may lead to a higher radiation or reduced interference resistance.

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This device must not be operated directly beside or stacked with other devices. If this is however nec- essary, this device should be observed with respect to its correct operation.

►

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with pro- tective earth.

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Before operation examine the device for evidence of damage. If you notice any safety relevant dam- age the device must not be used.

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Only the approved module protocol printer as specified in chapter 16 must be connected to the serial interface of this device.

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To remove leaked liquids do not tilt the device.

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To avoid possible crushing of fingers install and remove the agitation plate only when the device has been turned off.

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The device must not be operated within the vicinity of the patient.

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The blood bags or infusion containers within the device must not be in contact with the patient.

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During an on-going tempering process blood bags must not be removed from the device.

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If the device has to be opened during cleaning or servicing, it must be turned off and disconnected from the local power supply system by unplugging the mains cable since some device parts are under voltage even when the device has been turned off.

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Do not modify this equipment without authorization of the manufacturer.

Symbol description 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.

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Instructions for use SAHARA-III

ATTENTION Helpful information on the appropriate use of the device. If ignored an operat- ing error, malfunction or device defect may occur

 P

Operating instruction.

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.

Scope of supply SAHARA-III basic model and SAHARA-III basic model 115V each consist of: ►

the SAHARA-III platform incl. module warming plate

►

a mains cable

►

an instructions for use and

►

a service manual.

SAHARA-III MAXITHERM and SAHARA-III MAXITHERM 115V each consist of:

►

the SAHARA-III platform incl. module MAXITHERM

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a mains cable

►

an instructions for use and

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a service manual.

Device description The variants SAHARA-III basic model and SAHARA-III MAXITHERM enable blood components packed in plastic bags such as frozen plasma, cryopreparations, whole blood or erythrocytes to be thawed or warmed up prior to transfusion. The tempering process is carried out dry, which means without the use of water as the heat transferring agent. Instead of water, heat is transferred from a warming plate to the blood components according to the principle of thermal conduction (SAHARA-III basic model only), and from highly turbulent, heated ambient air according to the principle of forced convection (SAHARA-III basic model and SAHARA-III MAXITHERM). In comparison with SAHARA-III MAXITHERM the SAHARA-III basic model needs less time for blood product tempering. However, the SAHARA-III MAXITHERM has double the loading capacity for blood bags. Features: Safe tempering method ► Contamination risks by water-borne pathogens associated with water baths are prevented ►

Actively drying the bag surface provides hygienic conditions surrounding the blood bag

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Instructions for use SAHARA-III

►

Temperatures of the warming plate and ambient air are controlled to ensure a blood component quality equal to the quality obtained when applying the water bath method

►

Standardised thawing and warming procedure

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Delayed key reaction prevents unintentionally aborting the tempering process

37 °C function ► Tempering at a constant ambient temperature of 37 °C ►

Tempering of different blood components

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Tempering of bags with different filling volumes

Fast tempering function ► Rapid thawing and warming of blood components Temperature monitoring ► Contactless measurement of the blood component temperature by an infrared sensor ►

Fast availability of frozen blood components due to free of ice indication

►

Display of the blood component temperature from 29 °C to 37 °C in steps of 1 °C

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Documentation by use of a protocol printer available

Blood bag agitation ► Gentle agitation to achieve an almost homogeneous temperature profile within the blood bag and to prevent damage to the blood Integrated system test ► Checking the device functions ►

Calibration of temperature sensors

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Additional measuring apparatus not necessary

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Documentation by use of a protocol printer available

Easy operation ► No adjustment of tempering times and ambient temperatures required Modular set-up ► Rapid change between basic model and MAXITHERM ►

Infusion warming as additional function available

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Instructions for use SAHARA-III

Key pad START key

Fast tempering key

Free of ice LED

SAHARA III START

Blood component temper- ature display

°C

TEST

LED temperature alarm

LED ERROR

TEST key

STOP key

LED „Heating on“

LED POWER

STOP

Starting SAHARA-III is delivered with a separate mains cable for connecting the device power inlet on the left side of the housing to the local power supply system. SAHARA-III should not be connected to power sockets supplying systems which may cause power disorders such as photocopiers, refrigerators, etc. The installa- tion site chosen must be away from sources of heat and humidity. The installation base must be horizon- tal and should not be exposed to any vibration. Pressing the power switch on the left side of the housing causes SAHARA-III to switch automatically into standby mode. The device may only be connected to a public power supply with protective earth and has to be set up so that the mains plug can be disconnected from the mains supply any time. The device functions should be checked by the system test (see chapter 12.1), if SAHARA-III is started for the first time or after repair works.

7.1

Module warming plate

The module warming plate consists of an agitation plate which is connected to a coding plug by a flat ca- ble.

 Turn off SAHARA-III at the power switch and open the system flap.  In case of a built-in agitation plate pull the plate out of its plug-in connection and remove the cod- ing plug from the agitator mechanism. Do not tilt the agitation plate by hand!

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Instructions for use SAHARA-III

 Connect the coding plug “warming plate” to the socket at the rear of the agitator mechanism. Lo- cate the four pins on the underside of the warming plate onto the agitator mechanism and push to secure into position.

 Turn on SAHARA-III at the power switch. The system automatically enters the standby mode.

7.2

Module MAXITHERM

The module MAXITHERM consists of a double plate and a coding plug.

 Connect the coding plug “MAXITHERM” to the socket at the rear of the agitator mechanism. Lo- cate the four pins on the underside of the double plate onto the agitator mechanism and push to secure into position.

 Turn on SAHARA-III at the power switch. The system automatically enters the standby mode.

7.3

Module infusion warmer

The module infusion warmer consists of a coding plug.

 Connect the coding plug “infusion warmer” to the socket at the rear of the agitator mechanism.  Turn on SAHARA-III at the power switch. The system automatically enters the standby mode.

7.4

Module protocol printer

The module protocol printer consists of a document printer incl. data cable and a mains cable. During tempering of blood products the printer records the course of the blood component temperature and er- ror messages in event of a failure. The printer can also be used for automatic documentation of the sys- tem test.

 Turn off SAHARA-III 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 system.

 Connect the protocol printer to the serial interface at the rear of SAHARA-III by means of the data cable.

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Instructions for use SAHARA-III

 Turn on the protocol printer at the rear. The protocol printer automatically enters the standby mode. Please note further information in the separate operating instructions of the protocol printer.

Thawing and warming of blood components 8.1

Infrared sensor

The infrared sensor fixed on the upper margin of the blower housing scans a circular area of approximate- ly 7 cm2 on the left side of the agitation plate. During tempering of blood components the infrared sensor is used for measuring the temperature of the blood component which is placed within the scanning area without coming into contact with the blood bag. To achieve correct temperature measurement all addi- tional wrappings have to be removed from the blood bag (e.g. bonded plastic sheeting) before starting the tempering process and there must be no multiple or detached labels or loose tubes within the area of the scanned blood bag surface. In cases where additional wrappings cannot be removed, measurement of the blood component temperature can only be attained for blood bags with transparent and tight fit wrapping.

8.2

Positioning of blood bags

The variants basic model and MAXITHERM differ in their agitation plates. The warming plate of the basic model is actively heated from beneath with the blood bags placed on one tempering level. In contrast to this blood bags in the MAXITHERM are placed on a nonwarmed double plate with two different temper- ing levels. The loading capacity of SAHARA-III for blood bags is therefore doubled. To achieve optimal tempering times and an accurate measurement of the blood component temperature please bear in mind the following diagrams for the correct positioning of blood bags on the agitation plate:

8.3

Side view

Front view

Fast tempering function

The fast tempering function enables the SAHARA-III to warm or thaw blood components within a short period of time. Before using the fast tempering function, all of the following three conditions must be ful- filled:

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Instructions for use SAHARA-III

All blood components have the same initial temperature

Frozen blood components are colder than –20 °C

Minimum filling quantity for each blood bag: ►

►

Frozen blood component WITHOUT additional wrapping:

240 ml / 250 g

Frozen blood component WITH additional wrapping:

200 ml / 210 g

Liquid blood component:

190 ml / 200 g

If one of the three conditions cannot be fulfilled, then the blood components must be tempered with the 37 °C function (see chapter 8.4).

 If possible remove all additional wrappings and multiple labels from the blood bags (e.g. bonded plastic sheeting) or use blood bags with tight fit and transparent wrapping. This reduces the tem- pering time and enables a more precise measurement of the blood component temperature. Blood bags without tight fit wrapping or uneven surface may lead to extended tempering times.

 Place the blood bags on the agitation plate. Please note the information regarding positioning in chapter 8.2.

 Close the system flap and activate the fast tempering function by pressing the

key.

The LED within the ++ key illuminates.

 Press START. If the tempering process is not started within 20 sec, then the 37 °C function will be automatically re- activated. Approximately 30 sec. after pressing the START key, the blower starts tempering the blood components loaded on the agitation plate by warming the ambient air within the device. When used with the warming plate module the blood bags are also tempered by the warming plate. During an on-going tempering process the agitation plate and blood bags must not be removed from the device. When reaching the free of ice state the free of ice LED lights up permanently and an audible signal sounds. Starting from 29 °C the blood component temperature is indicated on the temperature display in 1 °C steps. Additionally, starting from a blood component temperature of 34 °C recurrent audible signals sound, with its intensity increasing during the tempering process.

 Terminate the tempering process by pressing the STOP key at the desired blood component tem- perature and remove the bags.

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Instructions for use SAHARA-III

By pressing the STOP key the fast tempering function is automatically deactivated. The system then au- tomatically enters the standby mode. If not stopped manually within 90 min, the tempering process will be automatically terminated and a long audible signal sounds. Afterwards the system enters the standby mode.

8.4

37 °C function

The 37 °C function allows blood components to be thawed or warmed at a constant ambient temperature of 37 °C. The 37 °C function must always be used, if at least one of the conditions for the fast tempering function cannot be fulfilled. To prevent unintentional use of the fast tempering function the 37 °C function is automatically activated after every tempering process. This is indicated by the unlighted LED within the ++ key.

 If possible remove all additional wrappings and multiple labels from the blood bags (e.g. bonded plastic sheeting) or use blood bags with tight fit and transparent wrapping. This reduces temper- ing time and enables a more precise measurement of the blood component temperature. Blood bags without tight fit wrapping or uneven surface may lead to extended tempering times.

 Place the blood bags on the agitation plate. Please note the information regarding positioning in chapter 8.2.

 Close the system flap and press START. Approximately 30 sec. after pressing the START key, the blower starts tempering the blood components loaded on the agitation plate by warming the ambient air within the device. When used with the warming plate module the blood bags are also tempered by the warming plate. During an on-going tempering process the agitation plate and blood bags must not be removed from the device. By reaching the free of ice state the free of ice LED lights up permanently and an audible signal sounds. Starting from 29 °C the blood component temperature is indicated on the temperature display in 1 °C steps. Additionally, by reaching a blood component temperature of 37 °C a recurrent audible signal sounds every 5 min.

 Terminate the tempering process by pressing the STOP key at the desired blood component tem- perature and remove the bags. If not stopped manually within 90 min, the tempering process will be automatically terminated and a long audible signal sounds. Afterwards the system enters the standby mode.

Infusion warming The module infusion warmer can be used to heat infusion solutions filled in plastic vessels or glass bottles as well as tubes, surgical instruments, contrast media, etc. to 37 °C. Always check, if and how long the items can be exposed to 37 °C. Only warm items which do not have to be agitated during tempering.

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Instructions for use SAHARA-III

 Place the items in the interior of the SAHARA-III.  Close the system flap and press the START key. The blower starts tempering the items by warming the ambient air within the device. Starting from 29 °C the ambient air temperature is indicated on the temperature display in 1 °C steps.

 Terminate the tempering process by pressing the STOP key and remove the tempering items. NM

Standby mode By switching on the device, after termination of the tempering process or after successful conclusion of the system test the SAHARA-III enters the standby mode. For this the 37 °C function is automatically acti- vated and the LEDs POWER, “Heating ON” and the LED within the STOP key are illuminated permanently. In case of SAHARA-III basic model the warming plate is heated up to 36 °C. The blower is turned off.

Error messages and trouble shooting In case of a system failure the device issues an error message by illuminating the ERROR LED and a single LED of the temperature display. Furthermore a system failure is indicated by a permanent audible alarm signal. If the module protocol printer is connected to SAHARA-III, the error will be documented on the printout. After announcing the failure the device is locked from further use and can only be re-started by turning off and on at the power switch. The device must not be used until the error is eliminated. The audible alarm signal during an error message can be deactivated for 2 minutes by pressing the STOP key. If an error message or a malfunction should arise during operation, then the temperature of the blood components or the tempering items must be measured immediately after removal from the device with respect to a mistempering. In case of blood bags this can be done easily and reliably with a calibrated thermometer: simply fold the bags along its length and place the thermometer in the hollow. If the ther- mometer reads a temperature that is unacceptable, then the blood components may become useless for transfusion purposes. Please contact the responsible physician! The following table assists you to identify 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 af- ter the other. If the measures listed in the table do not eliminate the error, then please notify the after- sales service (see chapter 14). Control 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 the information in chapter 12.1. Error

Description

Measure(s)

Infrared sensor soiled or defect

Clean the infrared sensor with as little glass cleaner as possible. Afterwards dry it.

message ERROR + free of ice

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Instructions for use SAHARA-III

Error

Description

Measure(s)

Wrong change of cod- ing plug

Turn off SAHARA-III at the power switch. Insert correct coding plug com- pletely into the socket of the agitator mechanism. Turn on SAHARA-III.

Inadmissible tempera- ture range

Module warming plate and MAXITHERM:

message ERROR + 29 °C ERROR +

If there is no blood bag within the scanning area of the infrared sensor, displace the blood bags on the agitation plate according to chapter 8.2 and start a new tempering process.

Check whether the scanned surface of the blood bag is plain (no addi- tional packaging, detached labels, or other objects). Remove any ob- jects that may cause a measuring error. Start a new tempering process.

30 °C + tempera- ture alarm

Module infusion warmer: Check ambient temperatures within SAHARA-III. As required remove tem- pering items from SAHARA-III. ERROR +

Warming plate tem- Check that the coding plug is pushed completely into the socket of the agi- perature sensor defect tator mechanism. If necessary loose the plug and push it in one more time.

31 °C ERROR +

Ambient air tempera- ture sensor defect

Notify after-sales service!

Blower defect

Cool the device down to room temperature, with the upper housing re- moved.

Ambient air heating defect

Notify after-sales service!

32 °C ERROR + 33 °C ERROR + 34 °C

(overheating possible)

+ tempera- ture alarm ERROR + 35 °C

Warming plate heating Check that the coding plug is pushed completely into the socket of the agi- defect tator mechanism. If necessary loose the plug and push it in one more time. (overheating possible)

+ tempera- ture alarm

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Instructions for use SAHARA-III

Error

Description

Measure(s)

No communication with warming plate or ambient air tempera- ture sensor

Check that the coding plug is pushed completely into the socket of the agi- tator mechanism. If necessary loose the plug and push it in one more time.

No communication with infrared sensor

Notify after-sales service!

message ERROR + 36 °C ERROR + 37 °C

Service and maintenance 12.1 System test By means of the integrated system test the device functions including the electromechanical components and temperature sensors are checked. The first and second test step checks the operation of the LEDs and the agitator mechanism. This has to be observed by the user. The further test steps are performed auto- matically. The conclusion of each test step is indicated by a short audible signal and an illumination of a temperature LED. The system test takes about 30 – 40 min for SAHARA-III basic model and about 20 – 30 min for SAHARA-III MAXITHERM. If a malfunction is observed by the user during the first and second test step then SAHARA-III should be suspended 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 shown on the temperature display. An explanation of the different error codes as well as the appropriate measures are shown in chapter 11.

 Install the module warming plate or the module MAXITHERM (see chapter 7).  Clean the agitation plate carefully and operate the SAHARA-III for approx. 15 min within the standby mode.

 For an automatical test report connect the module protocol printer to SAHARA-III (see chapter 7.4).

 Press the TEST key. All LEDs of the key pad are illuminated simultaneously for approx. 5 sec.

 Check the operation of the LEDs. The agitator mechanism starts a recurrent moving of the agitation plate.

 Check the movement of the agitation plate.  Keep the system flap closed for the following test steps. The device functions should always be checked, if SAHARA-III is started for the first time or after repair works. The system test must be performed at least every 3 months.

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IInstructions for use SAHA ARA-III

12..2 Cleaniing So tthat the SAH HARA-III is ready for basicc cleaning, the upper ho ousing and thhe agitation plate must first f be rem moved. All th he subsystem ms in the inteerior are now w freely acce essible and ccan be easilyy cleaned. Fu urther- morre, the upper housing can be cleanedd thoroughlyy at a more suitable site. For a regular dissinfection off the system alcohol-based disinfection agents shhould be use ed. However,, other disinfection ageents like oxyggen generati ng sporicides may be use ed during unnscheduled disinfections. d . Prio or to cleaning g also observve the notes of the disinffection agentt manufacturrer!

 Turn offf the device at the power switch and disconnect it from the loocal power supply s system m.  Open thhe toggle-typpe fastener oon the systemm’s rear paneel and lift thee back of thee upper houssing by about 2 cm.

 Keepingg the upper housing h at thhis angle, pussh it to the frront by abouut 2 cm. Lift and a remove it.  In case of a built-in agitation plaate pull the plate p out of its plug-in coonnection an nd remove th he cod- ing plugg from the aggitator mech anism. Do not tilt the agitation platee by hand!

 Clean thhe surface by b gently rubbbing it with sufficient disinfectant. In case of contamination with organic material (blood, secreti ons etc.) the e visible matterial should first be rem moved by meeans of a one-w way cloth or cellulose c soaaked with dissinfectant wh hich shall be discarded afterwards. Gen nerally, a dissinfection byy wiping is too be preferrred to a disin nfection by sspraying beccause the sp praying mayy endanger the t doer and d does not h ave a reliable effect. A disinfection d bby spraying should s only be b car- ried d out if the areas to clean n cannot be rreached by wiping. w Keeep liquids and d objects away from the blower and the t agitator mechanism.. Do n not use sharrp-edged or sharp s objectss or scouring g agents for cleaning. c

Pu utting outt of opera ation and d disposa al This pro oduct has be een made frrom high-quaality parts an nd materialss which can be re-used and a re- cycled. Therefore, do d not throw w the producct away with h normal houusehold wastte at the end d of its life. This is indicate ed by this syymbol on th he product. For F a producct return, pllease contacct your distribu utor or the manufacturer m r. Help prote ect the enviro onment by reecycling used products.

Aftter-sales service and a transsport If yo ou have queestions regarding the devvice, please contact c the manufacture m er or the sale es agency asssigned to yyour organization. Please e make a notte of the serrial number of the devicee and speciffy the error in i case of a malfunction n. If th he device hass to be shipp ped for repaiir, servicing or o testing, please pack it properly to prevent anyy trans- it damage. For this t we strongly recomm mend the use e of the orig ginal packagiing or a transport case author- a ized d by the man nufacturer or o your sales agency. The e manufacturer will assuume no responsibility for dam- agee incurring du uring transport caused bby improper packaging. Any carriagee charges forr the return of the devvice must be paid by the customer.

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Instructions for use SAHARA-III

We reserve the right to make improvements and modifications to the device which lead to a technical en- hancement.

Technical data Sizes:

WHD: 320 mm  325 mm  493 mm

Weight:

SAHARA-III basic model:

13,7 kg

SAHARA-III basic model 115V: 13,7 kg SAHARA-III MAXITHERM:

13,4 kg

SAHARA-III MAXITHERM 115V: 13,4 kg Rated voltage (±10 %):

SAHARA-III basic model:

230 V AC

SAHARA-III basic model 115V: 115 V AC SAHARA-III MAXITHERM:

230 V AC

SAHARA-III MAXITHERM 115V: 115 V AC Frequency:

50/60 Hz

Max. power:

655 W

Accuracy of temperature measurement:

Max. ± 4% at 37 °C

Ambient conditions during operation:

+10°C – +30°C 30 % – 75 % rel. air humidity 790 hPa – 1060 hPa max. 2000 m operating altitude

Ambient conditions during storage and -20°C – +50°C transport: 500 hPa – 1060 hPa

Expected service life:

10 years

Fuse:

2 x T 4,0 A H 250 V

Protection class:

Accessories Product

Product Code

Paper for protocol printer

79.8710.575

Ink ribbon for protocol printer

79.8710.576

Stainless steel tray

97.8710.501

Module infusion warmer for SAHARA-III

97.8710.550

Module protocol printer for SAHARA

97.8710.570

Star Micronics impact printer SP542MD

Module MAXITHERM for SAHARA-III basic model

97.8710.580

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Instructions for use SAHARA-III

Product

Product Code

Module warming plate for SAHARA-III MAXITHERM

97.8710.590

Declaration of conformity Due to the EC Council Directive MDD 93/42/EEC, appendix IX the dry tempering system SAHARA-III with the variants SAHARA-III basic model, SAHARA-III basic model 115V, SAHARA-III MAXITHERM and SAHARA- III MAXITHERM 115V is a medical product of class IIa. The company TRANSMED Medizintechnik GmbH & Co. KG is manufacturer according to the EC Council Di- rective 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

Warranty and guarantee During the warranty period, repairs on the device must only be carried out by SARSTEDT AG & Co. or by persons authorized by SARSTEDT AG & Co. In case of improper handling or repair, this warranty will be- come null and void. Warranty and liability claims are excluded if they can be traced back to one or several of the following causes: ►

Unintended use of the device.

►

Improper assembly, putting into operation, operation and maintenance of the device.

►

Operation of the device with defective safety equipment or incorrectly mounted or non-functioning safety features and protective devices.

►

Failure to comply with the information in the instructions for use concerning transportation, storage, assembly, putting into operation, operating, maintenance, setup work and waste disposal.

►

Unauthorized modifications to the device.

►

Catastrophic failure due to external cause and/or force majeure.

►

Improper repair work.

The product guarantee is 12 months, beginning with the date of purchase. This guarantee applies to the replacement or repair of any components which the manufacturer has found to be defect and which have not been modified without authorization, misused, or misapplied. Wearing parts are excluded from the product guarantee. The manufacturer sees himself 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.

SAHARA-III-Gebrauchsanweisung-2016-02-26-en.docx

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SAHARA System

SAHARA-III Instructions for Use Feb 2016