Operators Manual Selectomat PL - V - EN1
December 12, 2022 | Author: Anonymous | Category: N/A
Short Description
Download Operators Manual Selectomat PL - V - EN1...
Description
Daily putting into service Carry out described maintenance. Switch on mains switch. Switch on steam generator (if available) Run a vacuum test Run a pre--heating program Run a Bowie--Dick test
L Taking out of the sterilized / disinfected goods. P t Sterilizers with manual unloading: a Open door on unloading side. m o t c Take out sterilized or disinfected e goods. l e S
Close the door.
Operation Loading and starting
Sterilizers with automatic unloading:
Sterilizers with manual loading:
The door on the unloading side opens automatically, if the unloading ramp is not occupied.
Open door on loading side. Enter the goods to be sterilized or disinfected. Close the door.
Select a program. Press STAR START T
The loading cart is moved out of the chamber.
m r The door closes automatically. o F t r oSwitching off h S Switch off mains switch.
After a delay time, tthe he sterilizers switches off.
Automatic program run until Take out.
l Sterilizers with automatic loading: Select a program. Place a loading cart on the loading ramp. Door on loading side opens automatically. Loading cart is moved into the chamber. Door on loading side closes automatically. Automatic program run until Take out.
010044945--71130 / Rev07
a u a m g n i t a r e p O
Switch off steam generator (if available) Switch off the master switch after operation and in case of an emergency.
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Operating manual
Steam sterilizer Selectomat PL Order No.: Serial No.: Operator:
Your Your MMM Customer Service:
Manufacturer:
MMM--Kundenservice MMM--Ku ndenservice Bayern Hauptstraße Hauptstra ße 2
MMM customer service Headquaters Hauptstraße Hauptstraß e2
MMM Münchener Münchener Medizin Mechanik GmbH Semmelweisstraße Semmelwe isstraße 6
D--92549 D--92549 S Stadlern tadlern / O Opf. pf.
D--92549 D--92549 Stadler Stadlern n / Opf.
D--82152 D--82152 Planegg
Tel.: 01802 / 323629 Fax: 09674 / 80--318
Phone:: 09674 / 80--0 80--0 Fax: 096 09674 74 / 80---318 318
Phone: 089 / 89918--0 Fax: 089 / 89918--118 -118
Operating Operatin g manual manual Selectoma Selectomatt PL
010044945--71130 / R Rev07 ev07
0036
.
Notes to the machine designation
Selectomat PL 666666--2H -2H L
e.g.
Machine type Chamber size Version Version: --11 --22 H V G R
= = = = = =
single door two--do - door hori horizo zont ntal ally ly open openin ingg sl slid idin ingg do door or vert vertic ical ally ly open openin ingg slid slidin ingg do door or floor level loading cham ch ambe berr at the righ right, t, co cont ntro roll mo modu dule le on th thee le left ft sid sidee
L
=
cham ch ambe berr at the le left ft,, cont contro roll mo modu dule le on the righ rightt sid sidee
Legend
Symbols used in this operating manual:
Attention: hot surface!
Attention ! Risk of injury. Important ! Observe to eensure nsure correc correctt machine functioning.
Action, to be done by the operator operator..
Key stroke, to be done by the operator
Operating manual Selectomat PL
010044945-- 71130 / Rev07
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Contents
1
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 1.1.1 1.1.2 1.2 1.3 1.4 1.5 1.5.1 1.5.2 1.5.3 1.5.4 1.5.5 1.6 1.6.1 1.6.2 1.7 1.8
Appropriate use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Goods to be sterilized and sterilization processes . . . . . . . . . . . . . . . 6 Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Operating Safety Ordinance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Authorized operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Personal protective equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Rules of conduct to be observed during operation . . . . . . . . . . . . . . . 9 Working in the chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Opening of the sterilizing chamber door . . . . . . . . . . . . . . . . . . . . . . 9 Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Mobile telephones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Component room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Conduct in the event of emergency . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Program stop switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Master switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Residual risks of successful sterilization . . . . . . . . . . . . . . . . . . . . . . 12 Verif erification ication of the succe successful ssful sterili sterilization zation resu result lt – Validat alidation ion ooff th thee ssteriteri-
lization process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8.1 Validation of the processe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8.2 Routine tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9 Directives, regulations and standards . . . . . . . . . . . . . . . . . . . . . . . . .
6
13 13 13 14
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Machine description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.14.1 2.14.2 2.14.3 2.14.4 2.14.5 2.14.6
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pressure vessel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Locking mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Loading and unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Steam supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electric equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Airdetector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Steam manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operator identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A Auutomatic program preselection by barcode . . . . . . . . . . . . . . . . . . . Assembly and Commissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Program description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Universal 134 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Universal SD 134 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plastics 121 (standard) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection 105 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alloplast 134 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BD test 134 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15 16 16 16 16 17 17 17 17 18 18 19 20 21 21 22 22 23 23 24
2.14.7 Vacuum test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 2.14.8 Pass- through program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Operating manual Selectomat PL
010044945-- 71130 / Rev07
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2.14.9 Creutzfeldt--Jakob process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.14.10 Pre- Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15 Warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.16 Special programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.17 Program sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Display and operating elements . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.1 3.2 3.3 3.4 3.5
Operating and loading side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U Unnloading side (two door models) . . . . . . . . . . . . . . . . . . . . . . . . . . . Signal lamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indicating pressure gauges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.1 4.2 4.3 4.4 4.5 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6 4.7 4.7.1 4.8 4.9 4.10 4.11 4.12 4.12.1
C Coonditions for putting into service . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily putting into service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Waiting times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manual unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manual unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manual barcode entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delete barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delete all barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start a program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Start a pass- through program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Batch documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Display and print stored batch documents . . . . . . . . . . . . . . . . . . . . . Configuration of warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activate steam manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Configuration of standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledge malfunction messages . . . . . . . . . . . . . . . . . . . . . . . . . Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Release documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
Operating safety and malfunctions . . . . . . . . . . . . . . . . . . . . . . . . 57
5.1 Safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.1 Tim Timee me measuri asuring ng ssteriliz terilization ation and disinf disinfection ection and temperature monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.2 Airdetector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Extraordinary termination of the program sequence . . . . . . . . . . . . . 5.2.1 Program termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2.2 Emergency- Stop program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2.3 Manual termination of the program run . . . . . . . . . . . . . . . . . . . . . . . 5.2.4 P Prrogram interruption via program stop button . . . . . . . . . . . . . . . . . . 5.3 Additional door function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3.1 Suck back door seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
26 26 26 26 27 31 32 33 33 34 35 35 37 37 39 40 43 43 44 44 45 47 48 48 50 53 54 55 56 56 57 70 70 71 71 71 71 73 74 74
5.4 Analyses of malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4.1 Function test: vacuum pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4.2 Functio Functionn test: Lamps on unloading unloading side (two- door version only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4.3 Function test: Cold water valves of vacuum pump . . . . . . . . . . . . . . 5.4.4 Function test: Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
76 77 78 79 80
5.5
Screen calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.1 6.2 6.3 6.4 6.4.1 6.4.2 6.4.3 6.5 6.6
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IInnspection and maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . Replacing the door seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interior walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . External care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Component room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Software Licence Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
8
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
82 83 87 87 87 87 88 88 89
Annex
Service Menu Description Spare parts list Wear and tear parts list Piping System Diagram Wiring System Diagram
Operating manual Selectomat PL
010044945-- 71130 / Rev07
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1 Safety The follow following ing inf inform ormatio ationn mus mustt be tho thorou roughl ghlyy read read and obs obser erved ved by all per person sonss in charg cha rgee of ins install tallatio ation, n, com commis mission sioning ing,, ope opera ration tion,, or main mainten tenanc ancee of the theequ equipme ipment. nt. It is a matter matter of pers personal onal safety aand nd reliability of ster sterilization. ilization. The safety of the system, which which the ssteriliz terilizer er is par partt of, lie liess with the pers person on re respons sponsible ible of the installa installa-tion of the system. If the steri sterilizers lizers is not used acco according rding to it itss appro appropriat priatee uuse, se, the inher inherent ent protective protective functions of the the sterilizer may be affected.
1.1 1. 1 1.1.1
Appro ppropr pria iatte use use Goods to be sterilized sterilized and sterilizat sterilization ion p proc rocesse essess
All items it ems must be thoroughly prepre--cleaned -cleaned and di disinfected sinfected prior to sterilization in order to reduce the initial bioburden. Afterwards the items must be packed to protectt the tec theste steril rilize izedd item itemss aga agains instt rec reconta ontamina mination tion.. For Forthispurpo thispurpose se onl onlyy packin packingg material for sterilized items may be used that complies with the pertinent DIN or EN standards. The steam st steriliz erilizer er Selec Selectomat tomat PL is suita suitabl blee fo forr the steri steriliz lizat atio ionn of the thefo follo llowi wing ng medical devices: Instruments Utensils (e.g. kidney bowls, saline bowls) Clothes Other porous porous material (e (e.g. .g. dressing materials, swabs) Thermoresistent rubber rubber ware and plastic aarticles rticles Implants (e.g. alloplast prostheses) and for the disinfection of Utensils and and anae anaesthetic sthetic acc accessories essories The following minimum weight should be loaded: exclusively metal load: 50 g exclusively textile load: 150 g exclus lusive ively plastic tics load: 150 g other material, composite composite material or mixed load: 150 g The sterilizer is not suitable for the treatment of liquids in open or closed bottles and containers or for the discard sterilization of hospital waste (e.g. C waste) and pathogenic batches. The standard programs of the sterilizer are not suitable for the treatment of the Creutzfeldt--Jakob Creutzfeldt-Jakob disease germ. How However, ever, it is possible to install the Creutzfeldt-Jakob process as well. Chap. 2.14.9
6
Safety 1.1.2 1.1 .2
Se Serv rvic ices es
The services, services, in particular the sterilization steam must meet the requiremen requirements ts indicated in the technical data sheet, in the site preparation drawing and in the piping plan, in order to prevent damages caused by overpressure and corrosion. The services are to be checked regularly for their compliance with the requirements (see DIN 58946 T6).
1.2 1. 2
Opera Operati ting ng Safe Safety ty Or Ordin dinan ance ce
Please oberve the employer’s obligations resulting from the Operating Safety Ordninance. According to t o the Pressure Equipment Directive, the sterilizer Selectomat PL of chamber sizes above 669 (included) is a pressure equipment, category III and thus an equipment that requires requires surveillance in terms of the operating safety safety ordinance. Prior to putting into service, the sterilizer must be inspected by a technical expert (Operating Safety Ordinance (BetrSichV) §14 para. 1 and 2). According to the Operating Safety Ordinance, the following periods for the recurring inspections carried out by a technical expert are provided for:
Operating manual Selectomat PL
Outsidee inspec Outsid inspection tion (door mecha mechanism) nism)
2 year yearss (§ 17 an annex 5 item 26)
Inside inspection
5 years (§15)
Strength test
10 years (§15)
010044945-- 71130 / Rev07
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Safety 1.3 1. 3 Attention
Auth Author oriz ized ed oper operat ator ors s
Steam Ste am sterili sterilizer zerss may only be operat operated ed by per person sonss whose whose traini training, ng, knowled knowledge ge and practical experience ensure proper handling of the device.
Thes Thesee pers person onss are are to be instr instruc ucte tedd in th thee pr prop oper er ha hand ndlin lingg of the de devi vice ce by an ex expe pert rt with the aid of the operating instructions. An expert is someone who, due to his or her training, knowledge and current practical experience in the handling and the functions of the equipment disposes of the required know---how how (BetrSichV §1/7). The personnel responsible for the operation of the steam sterilizer must be trained no later than the time of delivery, and must have completely read and understood the ope opera rating ting ins instru tructio ctions. ns. The Theope operat rator or of the sterili sterilize zerr is res respon ponsib sible le forarra forarrangin ngingg sufficient instruction in the operation of the sterilizer. Staff trainin Staff trainingg con conce cerni rning ng the han handlin dlingg and mainte maintenan nance ce should should be carrie carriedd out reguregularly. MMM offers special training courses dealing with the release of sterilization processes. The operator must issue working instructions. These working instructions define the internal organization associated with the operation of the system. The name(s) of the person(s) authorised to operate the sterilizer must be recorded in a med medica icall ddevi evice ce log logboo bookk tha thatt m must ust be kep keptt in in acc accord ordanc ancee wit withh DI DIN N 58. 58.946 946,, par partt 6. If there is a change change in personn personnel, el, the new ope operating rating perso personnel nnel must be tra trained ined with the aid of these operating instructions. Additionally, the change in operating responsi spo nsibili bility ty mus mustt be rec record orded ed in the med medica icall devic devicee log logboo book. k. The own owner er is ulti ultimamately responsible for the instruction of all personnel.
8
Safety 1.4 1. 4
Pers Persona onall prote protect ctiv ive e equip equipmen mentt
Thesterilizerfeaturesanumberofsafetydevicesinordertoincreasetheoperational safety saf ety for forthe the ope opera rating ting per person sonnel nel.. Ne Never verthe theles less, s, the ope operat rating ing per person sonnel nel might might get injured by incorrect or improper operation.
Attention
During Dur ing operat operation ion the metal metal walls walls of the ste steril rilizin izing g chambe chamberr and the doo doors rs heat heat up to such such a de degr greethattouc eethattouchin hing g themwiththe themwiththe barehand barehand migh mightt lead lead to burn burns. s. Therref The efor ore, e, loadi loading ng an and d unloa unloadin ding g of go good odss to be ster sterili ilize zed d ma may y on only ly be perf perfor or-med with gloves and long--sleeved working clothes.
Attention
In case of maintenance work below the the door and in the component room, it is necess nec essary ary to secur securee the door door aga against inst uninten unintended ded act activa ivatio tion n by scr screwi ewing ng the safety screw in the blind hole of the door guide rail. The position of the safety screw scr ew must must be fixed fixed with a count counter er nut nut.. If n not ot obser observed, ved, there there is the risk of in jury from the door drive chain and the d door oor spring
Attention
During maintenance work the machine must be switched off.
1.5 1. 5
Rule Rules s of condu conduct ct to be obser observe ved d during during operation
1.5.1 1.5. 1
Attention Attention
Working orking in the chambe chamberr
Switch off the master switch and lock it to prevent unintended activation whenever work is done inside the chamber (cleaning, maintenance). Prior Pri or to enter entering ing the chambe chamberr, actuat actuatee the progr program am stop stop swi switch tch and withdr withdraw aw the key and keep it with you.
The mas master ter swi switch tch dis discon connec nects ts the equ equipme ipment nt all---pole pole from from the mai mains ns (se (seee chap.2.12) 1.5.2 1.5. 2
Opening Opening of the the ster steriliz ilizing ing cham chamber ber doo doorr
The program run is automatically controlled by the control system. The opening of the sterilizing chamber door is allowed by the controller and the electric safety system only if certain conditions are given to prevent any hazards hazards for the operator operator..
Attention
Operating manual Selectomat PL
It is therefore not allowed to force the sterilization chamber door open – not even in case of a malfunction.
010044945-- 71130 / Rev07
9
Safety 1.5.3 1.5 .3
Prog Progra ram m star startt
If certain components which have been tested for ccompliance ompliance to safety regulations should fail or are destroyed, operating errors can cause critical safety hazards.
Attention
For this reason the unit must not be started until the door has been closed. 1.5.4 1.5. 4
Important
Mobile telephones may be used in the room of the sterilizer only in case of emergency. Portable and mobile HF communication devices may interfere with medical electrical devices. 1.5.5 1.5. 5
Attention
Mobile Mobile te teleph lephone oness
Compon Component ent ro room om
Only instruc instructed ted person personss are are allowe allowed d to enter enter the compone component nt room. room. Risk Risk of in jury from hot machine parts, discharge of hot steam or water in case of malfunctions, from door drive and from defective electrical components.
10
Safety 1.6 1. 6 1.6.1 1.6. 1
Attention
Condu Conduct ct in the the even eventt of emerge emergenc ncy y Pr Progr ogram am stop stop switc switch h
If any irregularities or errors occur during the cycle run, immediately press the program stop switch.
Irregularities may include: unusual noises steam escaping from the c component omponent room start of a wrong program Termin erminat ation ion of the prog progra ram m in or orde derr to av avoi oidd da dama mage gess to th thee go good odss to be ster sterili ili-zed. Pressingg the pro Pressin progra gram m sto stopp switch switchinte interru rrupts pts the thecyc cycle le run runand andbri brings ngsthe the system system into a safe operating condition. Chap. 5.2.3. Notify an expert. Eliminate the irregularity or error which caused you to press the
Important
program progra m sto stopp switch switch.. The Thenn unl unlock ock the pro progra gram m sto stopp swi switch tch using using the key pro provid vided. ed. The goods to be sterilized must be considered as not sterilized. On two--door systems, only the door on the loading side can be opened. 1.6.2 1.6 .2
Attention
Mast Master er swit switch ch
In case of malfunctions of the system which could pose a threat to persons or prope property rty,, immedia immediate tely ly switch switch off the mas maste terr sw switc itch h and lock lock it to preve prevent nt unin unin-tended activation.
The mas master ter switch switch dis discon connec nects ts the system system (al (alll---pole) pole) from from the main mainss (se (seee also also cha chappter 2.13)
Operating manual Selectomat PL
010044945-- 71130 / Rev07
11
Safety 1.7
Residua Residuall risks risks of succes successf sful ul steri steriliza lizatio tion n
Successful sterilization is supported by a number of measures: The process relevant relevant parameters (s (sterilization terilization temperature, sterilization time) for all the sterilization programs comply with the EN 285 standard. During program run the sterilizer automatically monitors all process--relevant process--relevant parameters. In the ever everyy---day day start---up up proc procedure edureof of the sterilizer sterilizer,, a routin routinee test (Bow (Bowieie---Dick Dick test) is performed by the operator. The sterile material is protected against recontamination by means of suitable packaging.
Nevertheless a trouble--free trouble--free sterilization program run is no guarantee for the sterility of the t he sterilized material. The following residual risks that might lead l ead to nonnon--sterility must be observed: Insufficiant cleaning and disinfection call the sterilization result into question. The effectiveness effectiveness of the sterilization progra program m for the actual load that is used by the operator can only be verified by way of validation. Insuffic Insufficient ient steam quality and leakages of the chamb chamber er can caus causee inster insterility ility.. Such critical states are not recorded by a sterilizer without IPC. They must be controlled by a BowieBowie--Dick -Dick test and a vacuum test. The Bowie--Dick Dick test carried out daily during putting into service proves only that steam penetration in the test pack was satisfactory when the test was carried out. Aftersterilizationthepackingofthesterilematerialmustnotbemoistnordamaged. ged. Such Such items items mu must st be cons conside idere redd as no nonn---steri sterile le an andd mus mustt be sort sorted ed ou outt by the operating personnel prior to storing. It mu must st be note noted, d, howe howeve verr, that that a little littlewa wate terr on the theto topp of thepac thepacka kage gess are are ha harm rm-less, if they have dry off within 30 minutes after the sterile package is removed
from the sterilizer.
12
Safety 1.8
Verific erificat ation ion of the succes successfu sfull sterili sterilizazation result – Validation of the sterilization process
The verification of the successful sterilization result is effected by: Validation of the processe Routine tests Evaluation of the batch documentation 1.8.1
Validation alidation of the processe processe
The main purpose of the validation of sterilization processe carried out aaccording ccording totheMedicalDeviceAct(MDD)istoachievehighsterilizationassuranceandthus to protect the patient. Validation is the necessary proof of the process efficacy. Cleaning, disinfection and sterilization sterilization of medical devices are to be carried out according to the indications of the manufacturer and with suitable validated processes, so that the success of the process is assured and can be repeated and that the safety and the health of patients, users or third parties is not put at risk (according to MD operator directive of 29. June 1998 § 4 para. 2). Validation consists of commissioning and performance qualification. Commissi Commis sion oning ingis is usua usually lly effe effect cted ed when when a syst system em is in insta stalle lledd fo forr thefirs thefirstt tim time. e. The The installation conditions and the functions of the system are checked. During performance qualification, the sterilizer and the influencing parameters such as steam quality, packaging, loading and the goods to be sterilized are assessed. Performance qualification is repeated once a year. Performance qualification consists of. Documentation of the trays and goods goods to be sterilized as used in the hospital Selection of the difficult to sterilize goods (together with the person in charge of validation) Execution of measurements Assessment of the validation documentation Release for operation 1.8.2 1.8 .2
Rout Routine ine te test stss
Routine Rout ine tests tests con consis sistt of a con contro troll of the measur measuring ing sys system, tem, con contro troll system, system, Bow Bowieie-Dick Dick te test st and the vacu vacuum um test test and is to be ca carr rrie iedd ou outt du duri ring ng in insp spec ectio tion. n. Cha Chap. p. 4.2 and 6.2
Operating manual Selectomat PL
010044945-- 71130 / Rev07
13
Safety 1.9
Direct Directive ives, s, regula regulatio tions ns and standa standards rds
The steam sterilizer is designed and built with respect to applicable standards, directives and legal regulations. It is equipped with all required safety safety,, control and user instruments. According to the EC conformity declaration signed by the manufacturer, manufacturer, the steam sterilizer corresponds to the relevant stipulations of directive 93/42/EEC relating to medical devices, 97/23/EC concerning pres pressure sure equipment, 89/336/EEC concerning cern ing electr electromagne omagnetic tic compa compatibility tibility,, and 73/23/EEC 73/23/EEC conc concering ering elect electrical rical opera opera-ting equipment and it bears the CE mark. Unimpeded servicing access to all fittings, valves, pipes and electrial components of each machine must be possible. The following directives, regulations and standards were observed:
EC directive 93/42/EEC concerning medical devices
EC directive 97/23/EC 97/23/EC concerning pr pressure essure equipment equipment EC directive 89/336/EEC concern concerning ing electromagnetic compatibility EC directive 73/23/EEC 73/23/EEC concerning eelectrical lectrical operating equipment DIN EN 285 steam sterilizers EN60204EN60204 --11 safety of machin machines es DIN EN 61010--1 61010--1 and 61010 61010---22 --40 40 safety reg regulati ulations ons for electrical meas measuring, uring, control, monitoring and laboratory units. DIN EN 60601--160601--1--2 -2 electrical m medical edical devices; electromagnetic compatibility DIN EN 60601--1--4 1--4 electr electrical ical medic medical al devic devices; es; progr programmabl ammablee electr electrical ical medical systems AD2000 sheets
The follow following regulation regulations s and direc directives tives must be obser observed ved during during install installation ation and operation ofing steam sterilizers: BetrSichV - operational safety regulation TRB-TRB-- rules, particularl particularly: y: -- TRB -- line 000 -- General -- TRB -- line 500, 513, 532 (tests) -- TRB -- line 700 operating of pressure vessel TRBS Technical Technical rules ffor or operating saf safety ety DIN 58946 58946 T1, T6 and T7 sterilization, steam sterilization
14
2 Machi Machine ne descri descript ptio ion n The steam sterilizer Selectomat PL serves the steam sterilization of medical devices.
2.1 2. 1
Techn echnic ical al Data Data
Operator: Model:
Selectomat PL
Order No.: Year of delivery: Year of manufacture: Serial No.: Max.. per Max permiss missible ible ope opera rating ting temp tempera eratur ture: e:
145 ˚C
Max. permiss. operating overpressure of the pressure vessel:
3,2 bar
Dime Dimens nsio ions ns of us usef eful ul room room (HxW (HxWxD xD): ):
[dm] [dm]
Volume lume of pre ress ssuure vess vesseel inte interrior ior:
dm3
Volume lume of pre ress ssuure vess vesseel exte exterrior ior:
dm3
Capa Ca paci city ty of th thee pre ress ssuure vess vesseel:
StE StE (st steeriliz ilizaation tion un unit it))
Electrical connection values Nominal voltage:
230 / 400 Volt three- phase current
Nominal current: Nominal current consumption: Type of current: Adjusted sound volume level:
3/N/PE AC 400V Mean value: dB
Nominal frequency:
50 Hz
Peak value: dB
For system connections see “Technical Data Sheet” or “Installation Drawing”. For further technical details see pressure vessel drawing.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
15
Machine description 2.2 2. 2
Pres Pressu sure re vess vessel el
In accordance with the regulation for pressure vessels, the pressure vessel is designed, manufactur manufactured ed and tested for a maximum permissib permissible le operating overp overpress ressure ure of 3.2 bar and for a negative pressure of ---1 -1 bar bar..
2.3 2. 3
Lock Lockin ing g me mech chan anis ism m
Depending on the system version the sterilizing chamber is equipped with one or two sliding doors. Each Each sliding door is closed in a pressure---tight tight way by means of a deflatable special seal. The sliding door(s) open in vertical (V) direction.
2.4 2. 4
Load Loadin ing g an and d un unlo load adin ing g
On single--door single--door systems lloading oading and unloading of tthe he sterilizing chamber is done manually.
2 .5
Ste Steam supply pply
Steam supply is possible in the following versions: Steam supply from an in--house house steam source Steam supply from an electric electric steam generator either integrated or installed se
16
parately Combination of inin --house steam supply or electric steam generator. generator. Manual switching.
description ion Machine descript 2.6 2. 6
Cont Contro roll syste stem
The control system controls the automatic program run, batch documentation and the operator guidance. In ca case se of a ma malf lfun unct ctio ionn onthe on theau auto toma maticcyc ticcycle le ru run, n, a pr prog ogra ram m in inte terr rrup uptio tionn is initia initia-ted.
2.7 2. 7
Elec Electr tric ic equi equipm pmen entt
The ele electr ctric ic equ equipme ipment nt cor corre respo sponds nds to the VDE VDE regula regulation tionss in for force ce and is ins install talled ed according to the system of protection IP 33.
2.8 2. 8
Aird Airde etect ector
(option) The airdetector serves the monitoring of the sterilizer process process.. It checks by means of the temperature, if a leakage is present, to make sure, that the sterilizing conditions are met.
2.9 2. 9
Stea Steam m mana manage gerr
(option) The steam steam man manage agerr reg regula ulates tes the timed timed seq sequen uence ce of the progra programs ms of sev sever eral al ste sterili rili-zers, so that the steam is tapped from the supply system as evenly as possible. The sterilizer indicates its readiness for start on demand by means of a green lamp and the display. Only then the sterilizer can be loaded and started. The sterilizer must not be loaded earlier, as otherwise the goods to be sterilized would be heated up and dried to an unacceptably high degree. In sterilizers with automatic loading, the load is loaded only after start release by the steam manager. The barcodes may be readread--in -in prior to start release. Thesteammanagercanbeactivatedordeactivatedbyauthorizedpersonsonly.This is effected by changechange--over -over of the machine parameter.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
17
Machine description 2.10 2. 10 Stan Standb dby y (option) The standb standbyy fun functi ctions ons ser serves ves the red reduct uction ion of the ste steam am consum consumptio ption. n. If the theste steril riliizer is not used for a period of time that can be individually set (see chap.4.10) (no progra pro gram m act active ive,, scr screen eenis is not nottou touche ched), d),the thesta standb ndbyy mod modee is aut automa omatica tically llyact activa ivated ted.. As soon as the screen is touched, the standby mode is over over.. As the sterilizer cools down during the standby mode, we recommend to run a preheating program first after a long downtime. During standby, the jacket regulation is stopped and the sterilizer cools down (energy saving).
2.11 2.1 1 Operator Operator identificat identification ion It is possible to enter an operator ID either on the touch screen or by means of the barcode scanner. scanner. However, this ID is not checked by the sterilizer Selectomat PL! Itisprintedonthebatchprotocoltorecordthepersonwhohasstartedthecorresponding program.
18
description ion Machine descript 2.12 2.1 2 Automat Automatic ic progra program m presele preselect ction ion by barbarcode (add--on) The configur configuration ation of bbarco arcode de processing processing is eff effected ected bbyy the cus customer tomer serv service ice in accordance with customer demands. Depending Depend ing on the typ typee of the bar barcod codes es ent enter ered, ed, aauto utomati maticc pro progra gram m prese preselec lection tion by the sterilizer is possible. The preselected program is marked in the program selection men menuu aft after er ent entry ry of the bar barcod codes. es. All oth other er pro progra gram m are are dea deacti ctivat vated ed and ca canno nnott be selected. Standard version
If barc barcodes odes w with ith diff differen erentt progr program am nu numbers mbers and differen differentt steri sterilization lization temper temperaatures are entered, the program with the lowest temperature is chosen. If a bar barcod codee wit withh SD pro progra gram m is ent entere ered, d, the theSD SD pro progra gram m wit withh the low lowest estste steril riliiza zatio tionn te tempe mpera ratu ture re is ch chos osen en.. Ifthere Ifthere is no SD SDpr prog ogra ram m wi with th th thee low lowes estt ste steri riliz lizaation temperature available, the barcode is rejected. When When a barc barcod odee is en ente tere red, d, tthe he syst system em cche heck cks, s, if th ther eree is al alre read adyy a pr prog ogra ram m wi with th the same sterilization sterilization tempe temperatur raturee but diffe different rent steri sterilizatio lizationn time. If so, the barcodee is rejec cod rejected ted,, whi which ch mea means, ns, tha thatt all pro progra grams ms with withthe thesam samee ste steril riliza ization tiontem tem-perature must mave the same sterilization time. Barcodes with program program numbers of deactivated programs are rejected.
Flexible version
Progra Programs ms wit withh differ different ent sterili steriliza zation tiontime timess are are ac accep cepted ted provid provided ed tha thatt theste the sterili rili-zation temperature of all barcodes is the same. The order of barcodes entered determines which mode is used.
If progr programs ams with diff differen erentt steri sterilization lization temper temperature aturess are enter entered, ed, the compatibicompatibility test follows the standard mode. Sterilization times and temperatures must be the same. If programs programs with the same sterilization temperature but differ different ent sterilization times are entered entered,, the compatibili compatibility ty check foll follows ows the flexib flexible le mode. Only barcodes with the same sterilization temperature can be entered.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
19
Machine description 2.13 2.1 3 Assembl Assembly y and Commiss Commissioni ioning ng Important
The sterilizer is to be connected to the supply lines as depicted in the installation drawing, the technical data sheet and in accordance with local regulations. Make sure, that the supply voltage and current correspond to the values indicated on the type plate. Observee EN 610 Observ 6101010---1, 1, se sectio ctionn 6.1 6.10.2 0.2 whe whenn connec connecting tingto to the electr electric ic mai mains. ns. Mak Makee sure that: the existing screwed screwed cable gland is used as strain relief. the protective cable is the longest of all cables of the connecting cable.
Important
Switch off the main switch and lock it to prevent unintended activation whenever work is done on the system. Prior to commissioning, the operator must obtain approval from the authorities in charge. The operator receives from the manufacturer all necessary documents and a detailed list of all measures that are to be executed.
20
Machine descript description ion 2.14 2.1 4 Program Program descri descripti ption on The sterilizer offers 7 standard programs: 3 sterilization programs 2 routine test programs (B&D test, vacuum test) warmup program 1 pass--through through program (in 2 door sterilizers)
In add additio ition, n, a num numberof berof opt optiona ionall pro progra grams ms (sp (speci ecial al pro progra grams) ms)ar aree ava availab ilable le tha thatt can be modified to special requirements. If requested, the number of available programs can be reduced or extended by the MMM customer service. service. All available programs are displaye displayedd in the program sethat ca cann be ac acce cess ssed ed by the theto touc uchh scre screen en.. A ma maxim ximum um of 12 pr prog ogra rams ms lection lec tion menu menu that can be activated at the same time. The nex nextt page pagess con contai tainn a des descri criptio ptionn of the progra program m sequenc sequences es.. The expo exposur suree tem tem-perature pera tureare arethe the maximu maximum m oper operating ating temper temperature ature.. The corr correspo esponding ndingpres pressure/ sure/time time diagrams are shown in chapter 2.17 . The program times vary depending on the chamber size and on the loading in the stated sizes. 2.14.1 Universal Universal 134
(standard) Steam steril Steam steriliza ization tion pro progra gram m ac accor cordin dingg to the pul pulsing sing vac vacuum uum pro proces cesss wit withh additio additio-nal air displacement in the lower vacuum, fixed process sequence timing and vacuum drying. Program time: 30 - 40 min Exposure time: 5 min Expo Exposu sure re te temp mper erat atur ure: e: 13 1344 ˚C Goods to be sterilized Clothes Wrapped instruments Items that are difficult to ventilate
Operating manual Selectomat PL
010044945-- 71130 / Rev07
21
Machine description 2.14.2 Universal Universal SD 134
(standard) Steam ste Steam steril riliza ization tion pro progra gram m ac accor cordin dingg to the pulsin pulsingg vac vacuum uum pro proces cesss with withadd additio itio-nal air displacement in the lower vacuum, fixed process sequence timing and vacuum drying. Alternating aeration and evacuation in drying stage to enhance the drying efficiency. Program time: 60 - 70 m miin Exposure time: 5 min Expo Exposu sure re te temp mper erat atur ure: e: 134 134 ˚C Goods to be sterilized Clothes Wrapped instruments Items that are dif difficult ficult to dr dryy (e.g. extra heavy packages) 2.14.3 Plastics Plastics 121 (standard)
(standard) Steam ste Steam steril riliza ization tion pro progra gram m ac accor cordin dingg to the pulsin pulsingg vac vacuum uum pro proces cesss with withadd additio itio-nal air displacement in the lower vacuum, fixed process sequence timing and vacuum drying. Program time: 45 - 55 min Exposure time: 20 min Expo Exposu sure re te temp mper erat atur ure: e: 121 121 ˚C Goods to be sterilized
Heat sensitive (rubber, steam items resistent plastics)
22
description ion Machine descript 2.14.4 Disinfecti Disinfection on 105
(option) Steam dis Steam disinf infect ection ion pro progra gram m ac accor cordin dingg to the pul pulsing sing vac vacuum uum pro proces cesss with withadd additio itio-nal air displacement in the lower vacuum, fixed process sequence timing and vacuum drying. Program time: 30 - 40 min Exposure time: 5 min Expo Exposu sure re te temp mper erat atur ure: e: 10 1055 ˚C Goods to be disinfected Heat sensitive material Please note: This program is not listed listed by RKI (German Federal Health Office) of approved disinfection processes. 2.14.5 Alloplast Alloplast 134
(option) Sterilizatio Steriliz ationn pro progra gram m for forallo allopla plastic sticmate materia rial, l, suc suchh as pro prothe thesis sises es mad madee of sili silica ca gel at 134 ˚ C with subsequentd drying without vacuum. Program time: Exposure time: Expo Exposu sure re te temp mper erat atur ure: e:
Operating manual Selectomat PL
70 - 90 min 5 min 13 1344 ˚C
010044945-- 71130 / Rev07
23
Machine description 2.14.6 2.14 .6 BD test test 1 134 34
(standard) Test program for packed test packages at 134 ˚C with subsequent drying. The Bowie--Dick Bowie--Dick test is a st steam eam penetration test. It shows whether tthe he evacuation of porous sterilization material (clothes) and the subsequent steaming is sufficient for reaching the exposure temperature in the test load over the required exposure time. Program time: 20 - 30 min Exposure time: 3.5 min Expo Exposu sure re te temp mper erat atur ure: e: 134 134 ˚C This test must be carried out at operating temperature (e.g. following a cycle without load). The following message is displayed for information purposes No sterilization program Test pack
We recommend a test pack of the dimensions of 300 mm length, 220 mm width (height appr. 250 mm) and a weight of 6.5 kg for the BowieBowie--Dick -Dick test. The test pack must be composed of correspondingly folded cotton cloths. We recommen com mendd to usefresh usefreshly ly wa washe shedd cot cotton tonclo cloths ths to ens ensureidenti ureidentical cal startin startingg con conditi ditions ons for each test. The The te test st sh shee eett is to be inser inserte tedd in the mid middl dlee of this this pa pack ck,, whic whichh must must th then en be wr wrap ap-ped in a cloth/paper packing. We recommend using test sheets available from our AfterAfter--Sales -Sales Service Centre, MMM article articl e No. 531829 531829---3924. 392 4. Evaluation of test results
After the test run, the ttest est sheet must show a uniform discoloration. Bright spots on the test sheet indicate inadequate steam penetration.
Important
The Bowie--Dick test is not a test of sterility. For further information please consult our customer service centre. Please note: Please consult the booklet “Guidelines for the handling of sterilization material” for fur furthe therr ins instru tructio ctions ns con conce cerni rning ng the han handlin dling, g, pac packag kaging ing and ste sterili rilizat zation ion of difdifferent goods to be sterilized.
24
description ion Machine descript 2.14.7 Vacuum test
(standard) Automatic program for testing the chamber ttightness. ightness. It is man mandat datory oryfor forsat satisf isfact actory oryste sterili rilizat zation ion andthus forthe ass assura urancethat ncethat all ger germs ms have have been been kille killed, d, that that al alll ai airr is remo remove vedd from from the thest ster erili ilizi zing ng ch cham ambe berr an andd in pa part rtic icuular from the items being sterilized. Otherwise any remaining air will form „air pockets“ within porous items in i n which (due to the poor thermal conductivity of air) the necessary sterilizing temperature will not be reached. To demonstrate the absence of air leakages the program control features a vacuum to check the sterilizing chamber for tightness. Thus the sterilizing chamber is test to checked for air tightness. The test procedure procedure is as follows: The cchamber hamber is eva evacuated, cuated, followed by a holding time of five minutes. Then the actual vacuum testing time of 10 minutes follows. The total program runtime is approx. 20 minutes. The following message is displayed for information purposes No sterilization program. Vacuum test passed: The test test is con consid sidere eredd to be pas passed sed,, if dur during ing the test test time the pre pressu ssure re in the chamchamber rises by less than 13 mbar. mbar. The display then shows Taki Takingng--o -out. ut. Vacuum test not passed: If during the test time the pressure in the chamber rises by more than 13 mbar, the vacuum vac uum test test will willbe be rep repeat eated ed aut automa omatica tically lly.. Ifthe If thepre pressu ssure re rises rises abo above ve the theper permiss missiible value again, the error message Last Vacuum test failed will will appear at program end. Prior to further use the sterilizer must then t hen be inspected and repaired, if i f necessary, necessary, by an authorised technician. The vacuum test must then be repeated. 2.14.8 Pass--through program
(standard in 2 door version) Program for the return transport of empty loading carts from the unloading side ttoo the operatin operatingg side throu through gh the ch chamber amber of the syste system m (onl (onlyy in two---door door syste systems). ms). Only one door each can be opened. This pro progra gram m may als alsoo be use usedd for forser servic vicee pur purpos poses es (e.g. (e.g. cle cleani aning ng of the chambe chamber). r).
Operating manual Selectomat PL
010044945-- 71130 / Rev07
25
Machine description 2.14.9 CreutzfeldtCreutzfeldt--Jakob process process
(option) Steam sterilization program according to tthe he prepre--vacuum -vacuum process with additional air displacement in the lower vacuum, fixed process sequence timing and vacuum drying. According to tthe he RobertRobert--Koch-Koch--Institut -Institut (RKI) with its gui guideline deline ”Treatment of CJD ment CJD pa pati tien ents ts as we well ll as peop people le be bein ingg at risk risk of th thee CJ di dise seas asee an andd th thee ap appr proopriate sterilization of instruments”, latest issue on 8 May 1998 (part of the official bulletin bull etinof of the Ge Germa rmann hea health lth offic office, e, issue issue 41/1 41/1998 998,, No No.. 7, p. 279---285) 285) an exp exposu osure re timee ofon tim of onee hourat hourat a ste steri riliz lizat atio ionn te temp mper erat atur uree of of13 1344 Cisrequired.Inadditionspecial cleaning and disinfection is to be observed. (recommendation by RKI) ˚
2.14.10 Pre--Heating
(option) Program for prepre--heating -heating the sterili sterilizing zing chamber. On twotwo--door -door systems, only the door on the loading side can be opened afterwards, as opposed to sterilization programs.
2.15 2. 15 Warmu armup p (option) The warmup program allows the operator to program the Selectomat PL, that the sterilizer sterili zer starts running a given seque sequence nce of progr programs ams automatica automatically lly at a chosen time (preferably on the following day prior to the first shift). The start time of the Warmup can be configured for each day individually. A maximum of 5 programs can be set.
2.16 2.1 6 Special Special programs programs (option) Speciall progra Specia programs ms with individ individually ually set pprogr rogram am para parameter meterss can be installe installedd by the MMM customer service if required.
26
description ion Machine descript 2.17 2.1 7 Program Program sequenc sequences es The The next next page pagess show show th thee pr pres essu sure re/t /tim imee ch char arts ts of th thee in indi divi vidu dual al pr proograms:
P2 Universal 134 p n
o i t a u c a v E
g n n i o i t m a a u e c t a S v E
g n i m a e t S
n o i t a u c a v E
P7 BD --- Test 134 g n i t a e H
g n i z i l i r e t S
f e i l e r e r u s s e r P
g n i y r D
g g t n i n u i o r i s e A a e k l a e T R
atmospheric pressure
t
Operating manual Selectomat PL
010044945-- 71130 / Rev07
27
2 8
P 4 P l a s t i c s 1 2 1
p
Evacuation Steaming Evacuation Steaming Evacuation
p
Evacuation Steaming Evacuation Steaming Evacuation
P 3 U n i v e r s a l S D 3 1 4
a t m o s p h e r i c
Heating
a t m o s p h e r i c p r e s s u r e
p r e s s u r e
Heating Sterilizing
M a c h i n e d e s c r i p t i o n
Sterilizing Pressure relief Pressure relief Drying Drying
Airing Releasing
Airing
Take out
t
Releasing Take out
t
O p e
6 P Evacuation
8 5 0 m b a r 9 5 0 m b a r
0 1 0 0 4 4 9 4 5 7 1 1 3 0 / R e v 0 7
Steaming Evacuation a t m o s p h e r i c p r e s u r e
Heating
Evacuation Steaming
A l l o p l a s t i c s 1 3 4
Evacuation Steaming Evacuation
a t m o s p h e r i c p r e s s u r e
Sterilizing Pressure relief
Heating Disinfecting Pressure relief
Drying Drying Airing
Airing t
2
p
p
a r t i n g m a n u a l S e l e c t o m a t P L
B 1 6 / B
Releasing
7 1
Take out
Releasing t
Take out
5 P D i s i n f e c t i o n 1 0 5
M a c h i n e d e s c r i p t o i n
9
3 0
p
Evacuation Steaming Evacuation Steaming Evacuation
P 1 0 C r e u t z f e l d t
B 1 0
Evacuation
a t m o s p h e r i c p r e s s u r e
VT---Test 10 min
Heating Airing a t m o s p h e r i c p r e s s u r e
Sterilizing
6 0 m b a r
B 1 6 / B 1 7
Releasing
Pressure relief
Drying
Airing Releasing t
Take out t
3 Displ Display ay and and operat operatin ing g elemen elements ts 3.1 3. 1
Oper Operat atin ing g an and d lo load adin ing g si side de
Touchscreen
End
p
P 8 V a c u u m t e s t
M a c h i n e d e s c r i p t i o n
Printer (option)
Program stop switch
Mains switch Mains switch steam generator (option) Signal lamp red (malfunction steam generator) (option) Signal lamp green (steam generator on) (option) LCD display (steam generator) (option)
Operating manual Selectomat PL
010044945-- 71130 / Rev07
31
Displa Disp lay y an and d op oper erat atin ing g el elem emen ents ts 3.2 3. 2
1
2
Unloa nloadi ding ng side ide (two door models)
Pressure gauges for chamber pressure 3
4 0 --1 1 bar 5
Signal lamps
Program Stop Switch
Close door Open door
32
Disp spla lay y an and d op oper erat atin ing g el elem emen ents ts Di 3 .3
Sig Signal nal lamp lamps s
The colour signal lamps correspond to EN285: Colour
Meaning
On
Gree Gr een n
Rea eady dy for op opeera ra-tion
readyy for oper read operation ation progr program am runni running; ng; malfuncion occured
(MMM definition) Bl u e
Yell llow ow
door sealing pressure on
no program running; door sealing pressure off
In op oper erat atio ion n
progra pro gram m run runnin ningg
no progra program m run runnin ningg (relief) dur during ing door door mov moveement
program end
program over; door has been opened
machine malfunction
no malfunction
Door (s) locked
Cycle end
(EN285, 6.1.3.c) Red
Flashing
(EN285, 6.1.3 a)
(EN285, 6.1.3.b) White
Off
Malfunction
(EN285, 6.1.3.d)
door sealing pressure is being built up (in preparation) or being relieved
3.4 3. 4
Indic Indicat ating ing press pressure ure gauge gauges s
Jacket
The pressure gauge in the component room indicates the steam pressure in the ring channel jacket.
Compressed Compressed air
Thepressuregaugeisinstalledattheairpressurereducerinthecomponentroom and indicates the air pressure in the line leading to the switch cabinet.
Steam supply pressure pressure
The pressure gauge indicates the steam pressure in the steam supply line.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
33
Disp lay y an and d op oper erat atin ing g el elem emen ents ts Displa 3.5 3. 5
Touc ouch sc scre ree en
The sterilizer is equipped with a touch screen. Touching the buttons actuates the corresponding functions. signal lamps
Start
Open door Close door Cycle history Barcode management
Control menu
Messages
Program selection
Program information
34
4 Oper Operat atio ion n
4.1 4. 1
Condi Conditi tions ons for for putti putting ng into into serv servic ice e
Inspection and and maintenance plan exists Operating permission exists Validation has been carried carried out Sterilization programs that are not used have been blocked responsible for the operation has been carried out Instruction of the personnel responsible Working instruc instructions tions exist
4.2 4. 2 Important
Daily Daily putti putting ng into into serv servic ice e
If a st stea eam m gene genera rato torr is instal installe led, d, the thein instr struc uctio tions ns fo forr use use of th thee st stea eam m ge gene nera rator tormu must st also be observed when operating the sterilizer.
Carry out described maintenance
Press master switch
Press mains switch The integrated lamp lights up.
press the button P08 VACUUM TEST
start the vacuum test Access the program selection menu by actuating the following button.
press The result of the vacuum test must be recorded in the day protocol. If an air detector is not installed: carry out the vacuum test once a day.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
35
Operation If an air det detect ector or is ins install talled: ed: car carry ry out the vac vaccum cum test test eve every ry fou fourr we weeks eks,, acc accord ording ing to DIN 58 946, part 6.
-he ating or any other program for activate program P11 pre--heating heating the chamber
start the prepre--heating -heating program
after program end open the door and enter the Bowie--Dick test pack
close the door
select P07 B&D test 134
run the BowieB owie--Dic -Dickk test
36
Operation 4.3 4. 3
Wait aiting ing times imes
Do not not run run a prog progra ram m of a lo lowe werr te tempe mpera ratu ture re imm immed edia iatel telyy af afte terr a pr prev evio ious us prog progra ram m of a high higher er te temp mper erat atur ure, e, bbec ecau ause se the ch cham ambe berr wo would uld be to tooo ho hott fo forr such such a pr prog ogra ram. m. For this reas reason on the follow following ing waiting times for cooling are prescribed prescribed after after programs of the following temperature (guide values with open chamber door): 134˚C 105 ˚C : 40 minutes 105 ˚C : 30 minutes 121˚C 134˚C 121 ˚C : 10 minutes
→
→
→
It is advisable to plan the operational procedure accordingly.
4.4 4. 4
Manu Manua al unlo unloa ading ding Correct loading of the loading cart
Heavy containers must be arranged at the bottom and in the center of gravity!
Light weight and small containers Heavy containers
Loading cart
Transport cart
Make sure that the loading cart is firmly arrested on the transport cart.
Attention
The transport transport cart must be firmly firmly connect connected ed to tthe he ster sterilizer ilizer or the rramp, amp, be-
Attention
fore the loading cart is carried over.
The sterilizer is in phase Program selection
Open the door on the loading side
Enter the goods to be sterilized or disinfected.
Close the door
Operating manual Selectomat PL
010044945-- 71130 / Rev07
37
Operation select a program The selected program is marked on the screen.
start the program The selected program runs automatically. If textiles or hygroscopic items are loaded, make sure, that the program is started immediately afte afterr ente enteri ring ng the thego good ods. s. In ca case se of wa waiti iting ng tim times es it is be bette tterr to de depo posit sit the goods outside the sterilizer to avoid overheating. The goods must be entered only immediately before starting the program. The courses of pressure, temperature and air detector are shown on the display in real time. After a certain period of time, the remaining cycle time is displayed.
38
Operation 4.5 4. 5
Manu Manua al unlo unloa ading ding
After the program run is complete, the sterilizer remains iinn cycle stage Take out .
open the door
open the door The display shows the Program selection menu
Attention remove the sterilized or disinfected goods from the chamber Careful - hot - Alwa Always ys wear prot protective ective ggloves! loves!
Close the door
On two--door two--door systems the door on the unloading si side de can be opened and closed as ofte oftenn as nece necess ssar aryy unti untill the the do door or on th thee lo load adin ingg side side is op open ened ed.. The The do door or on th thee lo loaading side can only be opened, if the door on the unloading side hast been closed. After program run of either program 7 (Bowie---Dick Dick test), program 8 (V (Vacuum acuum test) program 11 (Heating up) or a disinfection program, only the door on the loading side can be opened in process stage Taking out . Please note: We recommend to keep the chamber doors closed when the system is not used in order to reduce heat loss and to avoid dirt accumulation in the chamber.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
39
Operation 4 .6
Operation ion
close the door The user menu has four different main interfaces: 1. Program selection menu
40
Operation 2. Online cycle menu
3. Remaining time
Operating manual Selectomat PL
010044945-- 71130 / Rev07
41
Operation 4. Control menu
The control menu serves to enter machine parameters and is almost only used by
MMM cust MMM custome omerr se serv rvic ice. e. It is ac acce cess ssibl iblee by a pa pass ss wo word rd to en ensu sure re,, tha thatt on only ly au auth thor oriized persons make the required settings. After the sterilizer is switched on by the mains switch and initialisation is over, the program selection menu is shown on the screen.
42
Operation 4.6.1 4.6 .1
Barc Barcod odee en entr try y
(add--on) Read in the barcodes with the barcode scanner at a distance of approximately 15 cm. The barcode window opens.
The barcodes entered are shown in the list. They are related to the program started next. The number of barcodes entered is shown on the bottom of the screen. 4.6.2 4.6. 2
Manual Manual barcod barcodee entry entry
(add--on) Barcodes that cannot be read in by scanner must be entered manually.
press this button to change to the barcode window.
press the entry field next to the arrow buttons; an alphanumeric field opens.
enter the barcode
confirm the entry
Operating manual Selectomat PL
010044945-- 71130 / Rev07
43
Operation press this button to save the barcode
quit the menu 4.6.3 4.6. 3
Delet Deletee barcod barcodes es
Barcodes entered can be deleted from the list.
press to change to the barcode menu
select the barcode to be deleted using the arrow buttons.
confirm the entry
delete the barcode 4.6.4 4.6. 4
Delet Deletee all bar barcod codes es
All barcodes entered can be deleted from the list.
press to change to the barcode menu
press to change to the barcode menu
press to delete all barcodes entered
quit menu
44
Operation 4.6.5 4.6 .5
St Star artt a pr prog ogra ram m
Start a program program in the prog program ram sele selection ction menu. Sele Select ct the re require quiredd progr program am on the touch screen.
select a program.
close the door.
start the program. To be able to start a program, the doors on the loading and unloading side must be closed and the sterilizer must be ready for operation. If user identification is active.
The user identification is prompted.
touch the entry field; an alphanumeric field opens.
enter the user ID
confirm the entry The user ID can also be entered by barcode scanner.
confirm the entry; the program starts. The onl online ine cyc cycle le dia diagra gram m is now shown shown on the screen screen.. Dur During ing the progra program m run run,, the curren cur rentt pr proce ocess ss cur curves ves of pre pressu ssure re and temper temperatu ature re are sho shown wn.. If ava availab ilable le the temtemperature curve of the air detector is also shown:
Operating manual Selectomat PL
010044945-- 71130 / Rev07
45
Operation
If the touch screen is not touched for a given period of time (to be set), the display changes chang es automa automatically tically and show showss the remain remaining ing cycle time, as well as the program program name, nam e, cyc cycle le num number ber of the cur curren rentt cycle cycle,, curr current ent cycle cycle sta stage, ge, cha chambe mberr pre pressu ssure re (re(re-
cording) and chamber temperature (recording). Touch the screen to change to the display of the online cycle menu.
46
Operation 4.6.6
Start a pass--through -through prog program ram
Start the program from the program selection menu.
Select P9 pass through
start the program The screen shows: The door on the unloading side can be opened. After the door on the unloading side has been fully opened, the program selection menu me nu is disp displa laye yed. d. The The door dooron on th thee un unlo load adin ingg side sideca cann be op open ened edse seve vera rall tim times es un until til the doo doorr on the lload oading ing side has bee beenn opened opened once. once. Th Thee doo doorr on the uunloa nloading ding sid sidee must be closed to open the door on the loading side.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
47
Operation 4.7 4. 7
Batc Batch h do docu cume ment ntat atio ion n
(add--on) After cycle end, the process data can be printed. The batch documentation contains the following information: general data about user, user, operator, prog program ram and batch characteristics of the pressure pressure and temperature curves as a ffunction unction of time charac character teristi istics cs of airdet airdetec ector tor tem temper peratu ature re as a fu funct nction ion of ttime ime (on (only ly if airdet airdetecector is installed) protocol of measured va values lues in clear text optionally, all barcode barcode numbers of labels rea readd in by barcode scanne scannerr The batch document saved in the sterilizer can be transferred to an external server server after after cyc cycle le end end.. Thetra The transf nsfer erred redbat batch ch docume documents ntscan canthe thenn be arc archive hivedd per perman manent ently ly on a separate storage medium. After a batch has been released, the operating personnel is responsible for the batch protocol to be transferred to the external archive. The customer is responsible for the con contro troll of of the ele electr ctroni onicc arc archive hive.. M Make ake sur suree tha thatt ther theree is no sys system tem malf malfunc unction tion
in the network connection. If a protocol could not be transferred to the electronic archive, either keep the corresponding paper printprint --out out or reject the corresponding batch. 4.7.1
Display Display and print stored stored batch batch docum documents ents
The The la last st 20 cycl cycles es st stor ored edin in the the ste steri riliz lizercan ercan be bedi disp spla laye yedd an andd print printed edin in thepro theprogr gram am selection or online cycle menu.
open the selection of stored protocols The file names of the stored batches are made up of the t he date, the program number number,, the program name and the batch number.
select a batch by means of the arrow buttons
confirm the selection The file name and the date of storage of the selected batch are displayed. For further information, information, such as program name or cycle times, procee proceedd as follows:
press this button for further information about the batch
48
Operation
To quit this menu
press or print the batch protocol
press The batch protocol is printed on the connected printer.
quit the menu.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
49
Operation 4.8 4. 8
Conf Config igur urat atio ion n of warm warmup up
(add--on) If automatic automatic war warmup mup is active active,, the ster sterilizer ilizer start startss automat automatically ically a progr programmed ammed series of progra programs. ms. The desir desired ed star startt times can be conf configure iguredd in the contr control ol menu for each day of the week. It is also possible to determine, on which days the warmup is to be effected. For example: warmup is to be effected from Monday till Friday but not on the weekend. Starting from the program selection menu
press this button
touch the pass word field to open the numerical pad; enter the user pass word
confirm the entry
confirm the pass word
touch the field warmup
50
Operation
Important
Activate the automatic warmup by setting a green tick for those days, warmup is desired.
touch the field of the day warmup is desired; a green tick appears.
touch the time field to enter the desired start time; hours, minutes and seconds are entered separately.
touch the th e hourhour--fi -field eld
enter the time in the now open numeric pad
confirm the entry Enter the minutes and seconds accordingly.
save the entry. After warmup is activated, the corresponding symbol is displayed on the bottom of the screen.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
51
Operation Determine the program sequence of warmup:
Recomme Rec ommende ndedd seq sequen uence ce::
8 VT 11 Preheating 7 B&D test (only possible if automatic loading and unloading exists)
touch the field for program sequence; the numeric pad opens
enter the corresponding program number (0 = no program selection)
conform the entry
save the entry
quit the menu
quit the control menu
52
Operation 4.9 4. 9
Acti Activa vate te stea steam m mana manage gerr
(add--on) The steam steam man manage agerr can onl onlyy be act activa ivated ted and dea deactiv ctivate atedd by author authorize izedd per person sonnel nel.. Starting from the program selection menu
press this button
touch the pass word field; enter the user pass word in the now open numeric pad
confirm the entry
confirm the pass word touch the field warmup Activate the steam manager by setting a green tick in the corresponding field.
Important
save the entry
Operating manual Selectomat PL
010044945-- 71130 / Rev07
53
Operation quit the menu
quit the control menu
4.10 4.1 0 Configur Configurat ation ion of stand standby by (add--on) Depening on the operating procedure, a time period can be set, after which the standby mode is activated.
press this button
touch the pass word field; enter the user pass word in the now open numeric pad
confirm the entry
confirm the pass word
touch the field warmup
activate the standby field
enter the time, after which standby is activated in the time field; enter hours, minutes and seconds separately.
touch the hour--field
enter the time in the now open numeric pad
54
Operation confirm the entry Enter minutes and seconds accordingly.
save the entry
quit the menu
quit the control menu
4.11 4.1 1 Acknowledge Acknowledge malfunction malfunction messages messages
Notes and malfunction messages are displayed on the bottom of the screen. Some messages must be acknowledged: Please acknowledge.
touch the message field enter the user pass word in the now open numeric pad.
confirm the entry
confirm the pass word
Operating manual Selectomat PL
010044945-- 71130 / Rev07
55
Operation 4.12 4. 12 Rele Releas ase e The goods of each batch must be controlled and released prior to use or storage in the sterile goods store. Release requires the following: As Asses sessme sment nt of the theful fulll pro proces cesss cycle cycle reg regar ardingthe dingthe cor correc rectt pro progra gram m select selection iontha thatt corresponds to the configuration, as well as the observance of the process relevant parameters, in particular temperature, pressure and times according to the results achieved during validation. Visual control for integrity of the packaging or sealing and for condensate on the packaging. Inspec Inspection tion of the mar marking king,, if nec necess essar aryy also also of the proces processs ind indica icator tors. s. If pro proces cesss indicators indica tors are used, the work working ing instru instruction ction for the relea release se must includ includee crite criteria ria for the evaluation of these. The batch can only be released if the batch documentation has been generated. It must be easy to distinguish released released goods from those not released. released. This can be done either by marking or by organisational measures.
4.12.1 Release Release documentat documentation ion
The res result ult of the relea release se mus mustt be doc docume umente nted. d. The rel relea ease se may be ef effe fecte ctedd throug throughh an appointed person. This documentation must show the person who releases and the reference to the cycle. Depending on the result of the release control it is acceptable to release individual packages of a batch and to reject others. If packages are rejected, it is necessary to document the reason for the rejection.
56
5 Operati Operating ng s safet afety y and mal malfun functi ctions ons
5.1 5. 1
Safe Safetty dev devic ice es
The steril sterilize izerr is equ equippe ippedd with th thee nec necess essary ary sa safet fetyy and mo monito nitorin ringg dev device icess to ena ena-ble ope operat ration ion with without out dan danger ger,, pro provid vided ed it is use usedd in acc accord ordanc ancee wit withh theapp the approp ropria riate te use (see chap.1.1 ). Should one of the errors occur as described below, and he corresponding alarm is indicated on the display, cause ofservice). the error must be remedied by an authorised person (preferably MMMthe customer Unless stated Unless stated othe otherw rwise ise,, the cyc cycle le run wil willl be con continu tinued ed as soo soonn as the malfun malfunctio ctionn has been removed. If more than one message occur simultaneously, these will be displayed one after the other other..
All pressures stated in chap. 5.1 are given as overpressure in bar. List of monitoring functions:
Operating manual Selectomat PL
010044945-- 71130 / Rev07
57
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Machine ready for operation Standby active
Machine is ready for operation The machine is in standby mode. Standby mode has just been left, the machine is heating up.
Machine is i s warming up. Please wait.
p l y n g m a o o i n l c m a i o l t p o y t o n r s o r d e d e i r l v o e t R D p r h t r h p i n c t t w a o c r a n b l t o a S i n r t o t p t n u r e u c r o e t o t n t n i i r P e g m a a s r s g e o r M P
r d Notes for the e e operator r b i m u a q e h r c t e z n i r e m u e s s g e r d e p e l e D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
-
x
-
-
-
-
-
-
-
-
x
-
-
x
-
-
-
-
-
x
-
-
x
-
-
-
-
Power failure Power failure f ailure Please acknowledge An alarm occured
that must be acknowledged. Loading door open Limit switch of loading door has been acuated when ready for operation. switch itch of unUnloading door open Limit sw loading door has been acuated when ready for operation. Limit switch of loa Loading door open ding door has been during cycle run acuated during program run. Unloading door open Limit switch of unloading door has been during cycle run acuated during program run. Time exceed loading door Time exceed unloading door
Time during opening of the loading door has been exceeded. Time during opening of the unloading door has been exceeded.
x
x
x
x
x
x
-
-
x
x
x
----
-
x
-
-
-
-
-
x
-
-
x
-
-
-
-
-
x
-
-
x
-
-
-
-
x
x
x
x
x
-
x
-
-
Call customer service
x
x
x
x
x
-
x
-
-
Call customer service
x
x
-
x
x
-
-
-
x
Remove door malfunction
x
x
-
x
x
-
-
-
x
Remove door malfunction
Remove malfunction and acknowledge message
58
Operating safety and malfunction Response of the unit p l y n g m a o m i o n l c o a l t p o o n i y t s r d r e d o e i r l v o e t R D p r h t r h p i c n w t t r n a o c a b l t o a S i n r t o t p t n u r e u c r o e t o t n t n i i r e P g m a a s r s g e o r M P
Message on the screen
Malfunction
Service door open on loading side
Switch of service door loading side has not been actuated.
x
x
----
-
x
-
-
-
-
Service door open on unloading side
Switch of service door unloading side has not been actuated.
x
x
----
-
x
-
-
-
-
Notes for the r e d e r operator b i u m a q e h r c t e n z i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
Close maintenance door on loading side during normal operation. Close maintenance door on unloading side during normal
operation. Remove obstacle on loading or unloading side. Acknowledge message on screen.
Safety bar on loading or unloading side has been actuated. The released door can only be opened after acknowledgement, if an alarm occured during cycle run, which requires acknowledgement. The acknowledge key Press acknowledge on the loading door key must be actuated to start the closing procedure. Door sealing pressure pressure Pressure switch of door sealing (K9) sitoo low gnals pressure below 1.8 bar, chamber un-
x
x
-
-
-
-
-
-
-
x
x
----
-
x
-
-
-
-
-
x
-
-
-
-
-
-
-
Actuate acknowledge button of loading side door.
x
x
x
x
x
x
-
-
x
Check steam supply
vacuum Pressure switch of Door sealing pressure pressure der too low door sealing (K9) si-
x
x
x
x
x
x
-
-
x
Check steam supply
x
x
x
-
x
-
x
-
x
Check steam supply
x
x
----
----
x
-
-
-
x
Call customer service
Safety bar on loading or unloading side actuated Door can be opened only after acknowled gement
gnals pressure below 1,8 bar, chamber under overpressure . Door sealing pressure pressure Door sealing pressure could not be built up could not be built up. Door sealing pressure pressure Door sealing pressure could not be relieved could not be relieved.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
59
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Chamber pressure at Chamber pressure out program start outside of tolerance when program start was tolerance Check pressure switch K17 and K17.1
prompted. Pressure switch chamber depressurized B17 and B171
p l y n g m a o o i n l c m a i o l p o o t y t s n r d r e d o l e i r o v R D p r h e r t t p i h c n t w t r n a o c a b l t i o a S t n r o t p t n u r u e r c o e t t o n t n i i r P e g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e n z i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
x
x
-
----
x
-
-
-
x
Call customer service
-
x
x
----
x
-
-
-
x
Call customer service
Compressed air sup ply too low Program STOP actuated
don’t switch withintolerance band. Compressed air supply of the machine is too low. Program STOP switch actuated.
Program interruption Program STOP actuated by the software. by operator At least one of the Pressure Pres sure P10, P1 P11, 1, P20 or P30 too high pressure transducers
Motor protection switch vacuum pump Temperature probe
P10, P11, P20 or P30 signals a pressure above 3999 mbar Motor protection switch of vacuum pump is reacting. Temperature probe of
chamber temperature control contr ol (T10) is defective. Temperature probe of Temperature probe recording recor ding defective chmaber temperature recording is defective (T11). Bottle probe defective Bottle probe defective
x
x
x
-
x
-
-
-
x
Check compressed air supply
x
x
x
-
x
-
x
-
-
x
x
x
-
x
-
x
-
-
x
x
x
x
x
-
-
x
x
Remove malfunction if necessary and release program stop switch Remove malfunction if necessary Check steam supply
x
x
x
x
x
-
-
x
x
Call customer service
x
x
x
x
x
x
-
-
x
Call customer service
x
x
x
x
x
x
-
-
x
Call customer service
x
x
x
x
x
-
-
-
x
Call customer service
control defective
60
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Temperature probe airdetector defective
Temperatur probe air detector (T20) defective. Cooling water temperature probe defective (T4). Pressure transducer
Cooling water probe defective Pressure Press ure transducer
p l y g o m n m a o i n l c a i o l p o o t y t s r d r n o l e d e i r o v R D p r h e t t r i h p c n t w t a o c r a n b l t o a n r S i t o t p t n u r u e r c o e t o t n t n i i r e P g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
x
x
x
x
x
-
-
-
x
Call customer service
x
x
x
x
x
-
-
-
x
Call customer service
x
x
x
x
x
-
x
-
x
Call customer service
control defective
Pressure transducer Pressure recording recor ding defective
Pressure transducer Pressure jacket defective Cooling water temperature too high Sterilization temperature exceeded Sterilisation temperature too low Pressure Press ure transducer chamber unacceptable difference (> 200 mbar)
Pressure transducer Pressure chamber unacceptable difference (> 60 mbar)
chamber pressure control (10= defective. Pressure transducer chamber pressure recording defective. (P11) Pressure transducer jacket defective (P20) Cooling water temperature too high (T4) Sterilization temperature too high. Sterilization temperature too low. Measuring values P10 and P11 differ by more than 200 mbar and none of the two transducers has completely failed. Measuring values P10 and P11 differ by more than 60 mbar but less than 200 mbar and non of the transducers has completely failed.
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Call customer service
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Check cold water connection Call customer service
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Call customer service
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Call customer service
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Call customer service
Operating manual Selectomat PL
010044945-- 71130 / Rev07
61
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Measuring values Temperature probe T10 and T11 (or T12 chamber unacceptable difference (> 5 K) and T13 in solution programs) differ in ready for operation by more than 5 K and none of the both pro-
p l y g o m n m a o i l c a i o t n l p o y t o n r s o r d e d e i r l o v R D p r h e r t t i h p c n t w t r n a o c a b l t i o a S t n r o t p t n u r u e r c o e t o t n t n i i r P e g m a a s r s g e o r M P x
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Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
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Call customer service
bes has completely failed. Temperature probe Measuring values T10 and T11 (or T12 chamber unacceptaand T13 in solution ble difference (> 0.8 programs) differ in K) stage sterilizing by more than 0.8 K and none of the both probes has completely failed. Sterilization chamber Cooling time is running, please wait. is too hot to start a program (risk of overheating). Start prevention is active. Sterilization chamber Cooling time is runis too hot to start a ning program (risk of overheating) . Start prevention is NOT active. Low pressure pressure jacket Low jacket pressure. Set pressure jacket Jacket pressure too low undershot. Failure jacket regula- Jacket valve not trigtion in heating/steri heating/sterilili- gered for too long.
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Call customer service
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Wait until machine is sufficiently cooled down.
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Wait until machine is sufficiently cooled down.
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Check steam supply Check steam supply
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zation
62
Operating safety and malfunction Response of the unit p l y g o m n m a o i n a l c o i l t p o y t o n r s o r d e d e i r l v o e t R D p r h t r h p i c n t t w a o c r a n b l t o a S i n r t o t p t n u r u e r c o e t o t n t n i i r e P g m a a s r s g e o r M P
Message on the screen
Malfunction
Last vacuum test failed
Last vacuum test has been failed.
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Pressure increase Pressure waiting time too high
Vacuum test failed, pressure increase too high during waiting
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Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
Make sure that the chamber is tight. Sterilization efficiency not garanteed. Make sure that the chamber is tight. Sterilization efficiency
time. Cycle manually advCycle manually advanced naced after program start. Parameter have been Parameters have been changed changed in the menu during program run. Warmup active Automatic program start is active. Warmup configured Machine is equipped incorrectly, program with warmup. The list of programs to be run not known contains a non--active program. Carry out maintenan- Maintenance interval is over. ce powerr Change buffer battery Buffer battery powe
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Call customer service
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Call customer service to make an appointment for inspection. Don’t switch off machine. Risk of data loss! Call customer
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of the control system below minimum value.
t em Airdetector: tempera- Airdetector: the temperature at the measuture too low
not garanteed. Program run not complete.
ring point is too low. Program interruption triggered by air detector.
Operating manual Selectomat PL
Mind when releasing the sterilization batch.
service. Amount of nonnon--con-condensible gas inacceptably too high, program interruption, if configured.
010044945-- 71130 / Rev07
63
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Airdetector: measuring point not reached Airdetector: temperature sterilizing too low
Airdetector: the meam easuring value has not been reached. Airdetector: Airdetector temperature during stage sterilizing has dropped below
p l y n g m a o o i n l c m a i o l t p o y t o s n r d r e d o l e i r o v R D p r h e r t t p i h c n w t t r n a o c a b l t o a S i n r t o t p t n u r e u c r o e t o t n t n i i r P e g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e n z i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
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Call customer service
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Amount of nonnon--con-condensible gas inacceptably too high, program interruption, if
sterilization temperature. Program interruption triggered by air detector. Loading: time excee- Time exceeding of ding loading cylinder loading cylinder movement during automatic loading. Automatic loading Loading stop stopped. Loading: waiting for Loading is waiting for a second cart. second trolley Time exceeding of Unloading: time exceeding unloading cy- unloading cylinder movement during aulinder tomatic unloading. Unloading ramp is Unloading ramp occupied occupied. Unloading should be effected. Unloading STOP Automatic unloading is stopped.
Line error steam ma- At least one connecnager ting line of the steam
Steam supply not yet available
manager is interrupted. No steam supply line of steam manager free.
configured.
Remove malfunction and acknowledge message.
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Remove malfunction cause.
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Remove loading cart from unloading ramp.
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Call customer service
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Wait for steam release (green lamp).
64
Operating safety and malfunction Response of the unit Malfunction
Message on the screen
Printing failed
Cycle data memory full
p l y n g m a o m i o i n l c o a l p o o t y t s n r d r e d o l e i r o v R D p r h e t t r i h p c n t w t a o c r a n b l t o a S i n r t o t p t n u r u e r c o e t t o n t n i i r e P g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e n z i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
Direct printing on USB printer has failed for various reasons.
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Cycle data memory is full.
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Check printer and refill paper if necessary and set to online. Reprint the batch protocol if i f necessary necessary.. Call customer service
Unloading: time exceeding door
Unloading: transport cart must be removed
Time exceeding: steam surge Time exceeding: air removal Time exceeding: streaming Time exceeding: streaming II Time exceeding: heating Time exceeding: pressure relieve Time exceeding: drying Time exceeding: aeration Unloading: door movement during trans port procedure procedure Unloading active Loading active
Time exceeding during door movement of automatic unloading. During automatic unloading on a connected transport trolley, it is removed. Time exceeding : steam surge Timee exc Tim exceedin eedingg : air removal Time exceeding : streaming 1 Time exceeding : streaming 2 Time exceeding : heating Time exceeding : pressure relieve Time exceeding : drying Time exceeding : airing Door movement unloading side during unloading. Unloading is active. Loading is active
Remove malfunction and acknowledg message.
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Call customer service
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Call customer service
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Call customer service
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Call customer service
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Call customer service
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Operating manual Selectomat PL
010044945-- 71130 / Rev07
65
Operating safety and malfunction Response of the unit p l y n g m a o o i n l c m a i o l p o o t y t s r d r n o l e d e i r o v R D p r h e r t t p i h c n t w t r n a o c a b l t i o a S t n r o t p t n u r u e r c o e t o t n t n i i r P e g m a a s r s g e o r M P
Message on the screen
Malfunction
Loading: time exceeding transport cyclinder Loading: time exceeding door
Time exceeding transport cylinder cylinder..
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Remove cart accumulation
Time exceeding of door movement during automatic loading.
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Remove door malfunction
Notes for the r e d e r operator b i m u a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
Loading: door movement during transport proceduree procedur Loading: program start failed Loading procedure procedure stopped
Door movement during automatic loading. Program start failed.
User selects program without loading while the loading procedure has already started. Network storage fai- Network storage failed. led Network printing fai- Network printing failed. led Connection Conne ction of C CAN AN Check connection to IO module nod EX 470 is interrupted or problem at plugged --in module. non--sterilization Attention: no sterili- A non--sterilization zation program program is active. Check loading door The limit switches of the loading door switch inconsistently inconsistentl y. The limit switches of Check unloading door the unloading door switch inconsistently inconsistentl y. Plotten fehlgeschla- Ausdruck auf Thermodrucker fehlge gen schlagen
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Call customer service
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Call customer service
RL
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S SV V
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Kundenservice anrufen
Check network connection Check network connection Call customer service
66
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Initialisierung Plotter fehlgeschlagen Türdichtung wird entspannt Vac--L -Liq iq Umschaltung Umschalt ung defekt
Initialisierung Plotter fehlgeschlagen Entspannen Türdichtung Relais--Selbsttest der Umschaltung Vakuum--/Lösungspro-
p l y g o m n m a o i l c a i o t n l p o y t o n r s o r d e d e i r l o v R D p r h e t t r i h p c n t w t a o c r a n b l t o a S i n r t o t p t n u r u e r c o e t o t n t n i i r e P g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
RL
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SV SV
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Kundenservice anrufen Kundenservice anrufen
gramme fehlgeschlagen Stützdruck nicht erStrützdruck in der Kammer konnte nicht reicht aufgebaut werden Stützdruck zu niedrig Stützdruck in der Kammer unterschritten Dampfversorgungs Dampfversor gungsDampfversorgungsdruck noch nicht erdruck noch nicht erreicht reicht Dampfversorgungs Dampfversorgungs Dampfversor gungsdruck zu gering druck zu gering Keine Türfreigabe Keine Türfreigabe Programmvorwahl Programmvorwahl manuell geändert Direktdruckk aktiv Direktdruc
Programmvorwahl manuell geändert Direktdruck aktiv
Zeitüberschreitung
Zeitüberschreitung
Entladevorgang Entladevorgan g Entladesystem nicht bereit Dampferzeuger nicht bereit
Entladevorgangnicht Entladesystem bereit Dampferzeugerr nicht Dampferzeuge bereit
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SV
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SV
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Operating manual Selectomat PL
Dampfversorgung prüfen Keine Freigabe der Türbewegung durch die Hardware Warten bis Ausdruckvorgang beendet Störung am Entladezylinder am beheben Störung Entladezylinder beheben
010044945-- 71130 / Rev07
67
Operating safety and malfunction Response of the unit Message on the screen
Malfunction
Parametereinstellun Parametereinstellun gen falsch: infektiöse Güter
Parametereinstellungen falsch: infektiöse Güter
p l y g o m n m a o i n l c o i a l t p o y t o n r s o r d e d e i r l v o e t R D p r h r i t p h c n w t t r n a o c a b l t o a S i n r t o t p t n u r u e r c o e t o t n t n i i r P e g m a a s r s g e o r M P RL
A
D
Z
SV
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Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
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Parametereinstellungen prüfen: Wenn Programmparameter “Infektiöse Güter” auf ’ja’ steht muss Parameter “Kondensatsterilisation” eben-
falls auf ja stehen Kundenservice anrufen Kundenservice anrufen Kundenservice anru-
T13 defekt
T13 defekt
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SV
PmT
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T14 defekt
T14 defekt
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SV
PmT
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P30 defekt
P30 defekt
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D
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SV
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PoT
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RL
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S SV V
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Kdm
Q
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S SV V
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Kdm
Q
Kundenservice anrufen
RL
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S SV V
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Kdm
Q
Kundenservice anrufen
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S SV V
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PoT
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Kundenservice anrufen Störung an Vakuumpumpe beheben und
Motorschutzschalter der Umlaufpumpe des Kondensators spricht an Motorschutzschalter Motorschutzschalter Umlaufpumpe Mantel der Umlaufpumpe des Mantels spricht an Motorschutzschalter Motorschutzschalter des Kammerlüfters Kammerlüfter spricht an Zeitüberschreitung Zeitüberschreitung Sicherheitsabsaugung Sicherheitsabsaugung Vakuumpumpe wegen Vakuumpumpe we Zeitüberschreitung gen Zeitüberschrei-
Motorschutzschalter Umlaufpumpe Kondensator
tung ausgeschaltet
ausgeschaltet Liquifant prüfen
Liquifant meldet Mantel voll Wasser am Beginn vom Kühlen
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D
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S SV V
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fen Kundenservice anrufen
Pumpe über Servicemenü neu starten Kundenservice anrufen
68
Operating safety and malfunction Response of the unit Malfunction
Message on the screen
Freigegebene Tür soll geöffnet werden und es läuft das Durchströmen der Kammer zur Geruchsentfer Geruchsentfer-nung Mantelkühlung aktiv Mantelkühlung vor Durchströmen Durchs trömen
p l y n g m a o m i o i n l c o a l t p o y t o s n r d r e d o l e i r o v R D p r h e t t r h p i c n w t t r n a o c a b l t o a S i n r t o t p t n u r e u c r o e t o t n t n i i r e P g m a a s r s g e o r M P
Notes for the r e d e r operator b i u m a q e h r c t e z n i r e m u e s s g e d r e p e e l D w o n k c A m a r g o P r
g n i y r d t u o h t i w n o i t p u r r e t n i
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A
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S SV V
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H2O2--Programm aktiv Es läuft ein Pro Airdetector Funktigramm zum Airde-onstest tector--Funktionstest Stützdruck zu niedrig Stützdruck beim Hei-
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D
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RL
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S SV V
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PoT
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Q
zen zu gering
Operating manual Selectomat PL
010044945-- 71130 / Rev07
69
Operating safety and malfunction 5.1.1
Time measuring measuring sterilizat sterilization ion and disinfe disinfection ction and temperaturee monitoring temperatur
When the sterilization temperature is reached the plateau time starts running. The same applies to disinfection. If the theco corr rres espo pond nding ingte temp mper erat atur uree falls falls shor shortt by a ma maxim ximum um of 0. 0.55˚C, th thee time time meameasuring sur ing is sto stoppe pped. d. Only after after the cor corres respon ponding ding set val value ue is rea reache chedd aga again, in, the time measuring is continued. If time measuring of a sterilization process is interrupted for more than 90 s, the sterilization sterili zation proc process ess is complete completeyy inter interrupte rupted. d. O Onn the displa displayy appe appears ars the malfuncmalfunction message sterilization temperature too low for too long. If the corresponding temperature falls short by more than 0,5˚C or is exceeded by more than 3 C the sterilization process is interrupted. On the display appears the malfunction malfun ction messa message ge steriliz sterilization ation temperatur temperaturee too low or sterilization temperature too high. Followed by program interruption chap. 5.2.1 ˚
Basically the same applies to disinfection (program 5) and the Bowie--Dick test
(program 7). The reference measuring point for temperature is in the vacuum pipe (PT100 probe). 5.1.2 5.1 .2
Ai Aird rdet etec ecto torr
The airdetector compares the test temperature with the set limit temperature. The measur mea suring ing time for the test test tem temper peratu ature re is rea reache ched, d, as soo soonn as the cha chambe mberr pre pressu ssure re has exceeded the ambient pressure prior to the last sterilization. If the set limit tem temper peratu ature re falls falls sho short, rt, the cyc cycle le is failed failed,, bec becaus ausee eith either er airrem air remova ovall was not complete or because there is a leakage in the chamber or the pipes. The faulty cycle is interr interrupted upted aand nd the mea measure suredd temper temperature ature and the malf malfunctio unctionn message is printed on the batch document. If the limit temperature temperature is exceeded exceeded,, the cycle is consid considere eredd passed and the measu measu-red temperature is printed on the batch document. Non--condensible condensiblegas gas forms airInpocke pockets ts on porou porous s load loadwhich whichconsi considera derably bly impairs the sterilization effectiveness. this case, the sterilization temperature is reached with a considerable delay or not at all. Airdetector monitoring is only onl y active, if the airdetector is connected and has been activated for the current program.
70
Operating safety and malfunction 5.2 5. 2
Extr Extrao aordi rdina nary ry termi termina nati tion on of the the program sequence
5.2.1 5.2. 1
Pr Progr ogram am termin terminati ation on
In case of malfunctions that affect the success of sterilization or the safe program run or if the pro progra gramm--stop -stop key is pre presse ssed, d, the progra program m is aut automa omatica tically lly termina terminated ted.. These malfunctions are shown in the table in chapter 5.1 .
Important
The goods to be sterilized must be considered as not sterilized. On two--door systems, only the door on the loading side can be opened. 5.2.2
EmergencyEmergency--Stop -Stop program program
The emergency stop program program is initiated in case of malfunctions with the message Pressure Press ure transducer control defective or Motor protection switch vacuum pump . In this ca case se the pre pressu ssure re in the steril sterilizin izingg cha chambe mberr is aut automa omatica tically lly set to atmo atmosph sphee-
ric pressure chap. 5.2.3. The goods to be sterilized must be considered as not sterilized.
Important
On two--door systems, only the door on the loading side can be opened. The doors doors of the ser service vice acce access ss and of the pres pressure sure vvesse essell must not be for forced ced open. 5.2.3
Manual Manual termin termination ation of the prog program ram run
If a malfunction occurs during program run, the program can be terminated manually. This possib possibilit ility y is provi provided ded for eme emerge rgency ncy operat operation ion only and may only only be ex-
Attention
ecuted by authorised persons.
Manual operation requires thorough knowledge of how the system works in order to prevent hazardous situations.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
71
Operating safety and malfunction The program run is terminated as follows: Touch the screen to stop the remaining time display.
touch the yellow arrow next to the batch number
touch the pass word field and enter the user pass word on the numeric pad.
confirm the entry Press the rightright --arrow arrow key ttoo enter the next cycle stages. Step through the cycle until stage Pressure relief . In cycle stage Pressure relief, steppi stepping ng fur furthe therr is onl onlyy pos possib sible, le, after after the cha chambe mberr pre pressu ssure re has reach reached ed atmosp atmospheheric pressure (1000 mbar). It is not possible to step further once the cycle stages Aering and Releasing have been reached. After releasing the door seals(s), the program is terminated. The display shows Take out and and Cyce manually advanced or. or. Please acknowledge.
touch the message field (at the bottom of the screen)
72
Operating safety and malfunction The pass word is prompted.
touch the pass word field and enter the pass word on the numeric pad.
confirm the entry
confirm the pass word The message appears: Ready for operation.
Attention
Be careful when opening the door – steam might escape! Please observe: observe: The sterilized sterilized material material is hot – always wear protec protective tive gloves! gloves!
After activation of the stepstep--function -function during the automatic program run only the
door on the loading side can be opened (on two door systems) in the stage Taking out . The material to be sterilized must be considered not sterilized.
Important
Basically the same applies to disinfection (program 5). After termination of the manual control, the malfunction of tthe he system is to be removedbythetechnicalpersonnelorbytheMMMcustomerservice.Priortofurther operation a cycle with an empty chamber must be run. 5.2.4
Program Program interruptio interruption n via prog program ram stop button button
Actuate the program stop button to trigger an automatic program interruption without drying.
press
Operating manual Selectomat PL
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Operating safety and malfunction 5.3 5. 3 5.3.1 5.3 .1
Addi Additi tion onal al door door func functi tion on Su Suck ck ba back ck door door se seal al
If the door cannot be opened, the door seal may not be fully sucked back. Remove this manually. In stage Ready for operation and Take out:
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word The control menu is displayed
touch the service field
74
Operating safety and malfunction touch the button Door Seal; the door seal is sucked back for a set period of time; the yellow lamp is on; the blue lamp is flashing.
return to the control menu
return to the initial menu
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Operating safety and malfunction 5.4 5. 4
Anal Analys yses es of malf malfunc uncti tions ons
In the the cont contro roll me menu nu,, the thest stat atus us of al alll ha hard rdwa ware re an anal alog og an andd dig digita itall inp input utss an andd ou outp tputs uts can be analysed.
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word
touch the field Hardware
Page through the hardware pages by means of the arrow keys. Use the electric diagram to assign the description of the inputs and outputs to the corresponding hardware elements. If the green lamp next to the hardware description is on, the input is occupied or the output is actuated.
76
Operating safety and malfunction quit the menu
return to the initial menu 5.4.1 5.4. 1
Functi Function on te test: st: vac vacuum uum pump pump
Check the function of the vacuum pump by a test in the control menu without running a cycle. Only possible when Ready for operation!
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word
touch the field Service
touch the field Pumps; the vacuum pump is switched on for 10 seconds.
quit the menu
return to the initial menu
Operating manual Selectomat PL
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Operating safety and malfunction 5.4.2 5.4. 2
Functi Function on test test:: La Lamps mps on unloa unloading ding side
(two--door version only) Check the function of the lamps on the unloading side in the control menu. Only possible when Ready for operation!
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word
touch the field Service
touch the field Lamps; the lamps flash 3 times
quit the menu
return to the initial menu
78
Operating safety and malfunction 5.4.3
Function Function test: test: Cold water water va valves lves of vacuum vacuum pump
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry confirm the pass word
touch the field Service
touch the field Cooling
quit the menu
return to the initial menu
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Operating safety and malfunction 5.4.4 5.4. 4
Functi Function on te test: st: Unl Unload oading ing
select P9 passing through
open door
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word
touch the field Service
touch the field Unloading The unloading cycle is started.
quit the menu
return to the initial menu
80
Operating safety and malfunction 5.5 5. 5
Scre Screen en cali calibr brat atio ion n
If the touch screen does not react to the touches, it may need to be calibrated.
press this button
touch the pass word field and enter the user pass word in the numeric pad.
confirm the entry
confirm the pass word
touch the field Service
touch the field Calibration; 3 gridlocks appear one after the other. Try to touch these as accurate as possible.
quit the menu
return to the initial menu
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6 Main Mainte tena nanc nce e
6 .1
General
Special care must be attached to repeated inspections and to regular maintenance of safety devices (pressure control devices) as well as of system components (closing mechanism and pressure vessel) in accordance with the regulations for pressure vessels and the AD sheet. A cycle counter is integrated in the control system. The current cycle number is al ways indicated on the display or monitor. The sterilizer is equipped with a maintenance counter. The cycle number, after which the first inspection and maintenance is to be performed, performed, is entered when the system sys tem is com commiss mission ioned ed (by MMM cus custome tomerr ser servic vice). e). Wh When en this cyc cycle le num number ber ist reached, the message Carry out maintenance is displayed in Program selection
mode and during program run on the display or the monitor. A new cycle number is entered, after which the next inspection and maintenance is to be carried out and the display is cleared from the screen. Depending on the extent of utilization, we recommend to have an inspection and maintenance after 800 cycles, at least however, once every six months.
Attention Attention
Important
During maintenance work below the door, the door must be secured against unintended activiation by screwing in the safety screw. The sterilizer must be switched off during maintenance work.
If the machine is not used for a period of more than 4 weeks or in case of the risk of frost, remove the locking screws at the bottom and drain the vacuum pump and circulation circu lation tank. Treat Treat the unit with antianti--freez -freezing ing agen agentt (MMM articl numbe numberr 604315--).
82
Maintenance 6.2
VBS:
Serial No.
Inspect Inspection ion and mainte maintenanc nance e interv intervals als
Insp Inspection ection or mainte maintenance nance duty acco according rding to the “quick lock closin closingg mecha mechanism” nism” desc description ription Inspection and maintenance work
Comment
Daily
1.1
According to DIN 58 946, part 6 regular record recordss are to be kept in a medical device logbook on batch documentation, coordination of temperature curves or temperature / pressure curves (if available) as well as the tests, inspections, maintenance and repair work performed. Wh When en the doo door(s r(s)) is (ar (are) e) clo closed sed for the first first time time,, th thee pprop roper er fun functio ctionin ningg must must be che checke ckedd VBS by activating the safety rail (the door must run to “OPEN” position immediately).
1.2
VBS
Ch Chec eckk the tig tightn htnes esss of the door door se seal al(s (s). ).
The seal is automa automatically tically chec checked ked for vacuu vacuum m tigh tightness tness by the va vacuum cuum test pr progra ogram. m. In the following empty cycle run the seal must be checked for overpressure tightness.
In case of leakages the se seal al must be replaced by an expert technician. technician. The seal must be
insta installe lledd in su such chaa wa wayy tha thatt the the conn connec ectio tionn area(glu area(gluee jo joint ints) s)is is pla place cedd in th thee la late tera rall gr groo oove ve and is not charged with tensile load. Che Check ck the dirt dirt sieve sieve in the cha chambe mberr bot bottom tom and rem remove ove and cle clean an as nee needed ded..
1.3
Weekly
2.1
Tho Thorou roughly ghly cle clean an the loa loadin dingg roo room m (in col coldd con conditi dition) on).. Cov Cover er the pip pipee con connec nector torss in the chamber before you start this cleaning process in order to prevent foreign matter from entering into the pipe system.
Quarterly
3.1 3.2 3.3 3.4
Op Open en and clean clean the dirt dirt trap trap in the sup supply ply and dis discha charg rgee line lines. s. Op Open en and clean clean the rever reverse se pre pressu ssure re val valves ves;; repla replace ce the sea seals ls if nec necess essary ary.. Che Check ck all ducts ducts and fitt fittings ings for the their ir tigh tightne tness, ss, and tigh tighten ten the scr screw ew fittings fittings as nee needed ded.. Dr Drain ain the wa water ter sep separ arato atorr at the mai mainte ntenan nance ce unit with within in the com compre presse ssedd air sup supply ply for pneumatic valve control. Thor Thorou ough ghly ly dust dust the entir entiree area area of the inter interio iorr spac space. e. Che Check ck the adj adjust ustmen mentt of the pre pressu ssure re swi switch tches es for ves vessel sel and seal seal pre pressu ssure. re.
3.5 3.6
Operating manual Selectomat PL
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Maintenance Serial No.
Inspection and maintenance work
Comment
Every 6 months
4.1
For reasons of operating safety, functionality and economy, we recommend to have the steam steri sterilizer lizer chec checked ked by by an ex expert pert ever everyy six months in acco accordanc rdancee with BetrSic BetrSichV hV § 1/7 (preferably MMM customer service). The result is to be entered in the medical device log book. Che Check ck do door or lo lock ckin ingg and and cl clos osing ing proc proces ess: s: VBS
e sp ay o a ng or un oa ng oo sapp ppea ears rs ro rom mt em mon on tor a ter ter t e oorr ope pen n sa closing position has been reached.
The locking do door or must stop reliable in its end position. Che Check ck the pre pressu ssure re con contro troll ddevi evice ce tha thatt pprov rovide idess the the no---pressu pressure re sign signal al for the pressu pressure re VBS vessel (check B 17 and B 171, switch value: 0,05 bar)
4.2
Check door limit switches S 11 and S 111 (S 13 and S 131 in case of twotwo --door door version) or t g t t an prop proper er unct unct on. on.
4.3
Start any pr program ogram (exce (except pt vacuum test)
Relays K 17 and K171 in w working orking position (picked up) up),,
If Ifth thee pr pres essu sure re in the thepr pres essu sure re vess vessel el rise risess by mor moree than than 0.0 0.055 ba barr, th thee tw twoo rela relays ys K 17 an andd K 171 must drop (can be observed in the control cabinet).
Che Check ck the pre pressu ssure re con contro troll devi device ce for the pre pressu ssure re in the doo doorr sea seall groo groove ve (conta (contact ct B 220, 0, VBS switching value:1.8 bar ±0.2):
Remove the cable top from pilot valve Y 09 ((11 fastening screw). screw).
The steam valves to the pressure vvessel essel must close as soon as the pressur pressuree drops below 1.8 bar.
After 3 minutes the message ““Seal Seal pressure too low” appears appears on the display module. Ope Openn and cle clean an the con conden densat satee dra drain; in; rep replac lacee the ins insert ert if nec necess essar aryy. Op Open en an andd cl clea eann (if (if insta installe lled) d) the the retur returnn st stop op.. Clea Cleann the sterile sterile airing airing filter filter,, che check ck for dam damage agess and repla replace ce if nec necess essar aryy. Che Check ck the doo doorr sea sealing ling of the pre pressu ssure re ves vessel sel for dam damage age or we wear ar.. Che Check ck the scr screw ew fitting fittings, s, pip pipee con connec nection tionss and pne pneuma umatic tic line liness for tigh tightne tness. ss. Che Check ck the set setting ting of the steam steam and air pre pressu ssure re red reduce ucerr (if ins install talled) ed),, re---adjust adjust if nec necess essary ary.. Che Check ck the toot toothed hed bel beltt aatt th thee sl slidin idingg ddoor oor clo closin singg me mecha chanis nism m fo forr w wear ear and repla replace ce iit, t, if necessary (only H and G version). Test the max maximum imum clo closing sing for force ce of 150 N (on (only ly in H ver version sion)) Check the setting of the therma thermall wate waterr valve and re---adjust adjust if nece necessar ssaryy. Che Check ck the mini minimum mum neg negativ ativee pre pressu ssure re (va (vacuu cuum) m) of the vac vacuum uum pum pump. p.
4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.11 4.12 4.13
84
Maintenance Serial No. 4.144 4.1 4.155 4.1 4.16 4.17 4.17 4.18 4.19 4. 4.20 20 4.21 4.22
Inspection and maintenance work Ch Chec eckk ab abso solut lutee pres pressu sure re tran transd sduc ucer er Ch Chec eckk the te temp mper erat atur uree me meas asur urem emen entt devi device ce Che Check ck tthe he eelec lectric trical al eequip quipmen ment. t. Th Thee gr groun oundd ccond onduct uctor or iiss to be checke checkedd separ separate ately ly and particularly for a tight seat (observe regulations of local electric supply company.) Ch Chec eckk pip pipee inte interr rrup upto torr for for its func functio tioni ning ng.. Perf Perform orm a trial oper operationa ationall run run and chec checkk the cycle run for corr correct ect timing. Check pres pressure sure and temperature measuring devices and their displays. Bowie---Dick Dick test with subse subsequent quent handi handing ng over to the oper operator ator.. Re Read ad th thee numb number er ofcyc ofcycle less from from the the sc scre reen en an andd en ente terr th this is nu numb mberin erin th thee asse assemb mbly ly repo report rt an andd in the medical device logbook. If requ requested ested by the oper operator ator,, perf perform orm bacte bacteriologi riological cal test with bio--indicators -indicators acco according rding to DIN 58 946, part 3. Che Check ck the cas castor torss for suf suffic ficien ientt lub lubric ricati ation. on.
Comment
Operating manual Selectomat PL
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85
Maintenance Serial No.
Inspection and maintenance work
Comment
Yearly
5.1 5.3 5.4 5.5
5. 5.66
Insi Inside de vis visua uall ch chec eckk of the the steri steriliz lizat atio ionn cham chambe berr. VBS Che Check ck roller rollers, s, drive drive moto motorr, cchai hain, n, doo doorr spr spring ing,, sslipp lipping ing clu clutch tch,, guid guidee rails rails of doo doorr drive drive VBS Che Check ck do door or su susp spen ensi sion on,, door door holde holders rs (pre (press ssur uree fram frame) e) an andd scre screwe wedd cl clut utch ches es (d (doo oorr be bear arin ing) g).. VBS Che Check ck if in cas casee of of ove overpr rpress essure ure at pre pressu ssure re transd transduce ucers rs P 110, 0, P1 P11, 1, P20 or P 3300 th thee val valves ves Y03 close. For this purpose, disconnect the plug from the pressure transducer and connect a pressure transducer of 0 – 250 mbar (4 – 20 mA) to simulate too high a pressure. Ch Chec eckk pr pres essu sure re co cont ntro roll of ja jack cket et.. Compare the pressure value of the pressure transducer (screen) with the value of the manome man ometer ter.. In cas casee of 134 C programs programs the pr pressur essuree in the jacke jackett must nnot ot exc exceed eed 2.4 bar bar.. Clea Cleann the roller rollerss and gre grease ase the bea bearin ringg of loa loadin dingg car carts ts for flo floor or lev level el loa loading ding mac machin hines. es. We reco recommend mmend lubric lubricant: ant: KLÜBE KLÜBERSYN RSYNTH TH VH1 64---1302 1302 artic article le numbe numberr 06345 063457070--3830 -3830 ˚
5.6
5.7
Che Check ck the scr screw ew fitting fittingss pro provid vided ed for the fixatio fixationn of the doo doorr clu clutch tches es for cor corros rosion ion..
After appr. 200 cycles
6.1
We re recom commen mendd the follow following ing mea measur sures es to inc increa rease se the ser servic vicee life life::
Türdichtung Türdichtung mit geeig geeignetem netem Werkz erkzeug eug entfe entfernen rnen (z. B. MMM---Artikelnummer Artikelnummer 010073564)
Clean the seal groo groove. ve. In so doing, the surface surface of the seal groo groove ve must not be roughened roughened or damaged. Abrasive grain must not be smaller than 180.
Grease the lateral sur surfaces faces of the seal groov groovee with the MMM special lubricant for seals of silicon siliconee rubbe rubber, r, MMM item numbe number: r: 061304 06130477--3830, -3830, in orde orderr to repr reproduce oduce the lubrication film.
Fix the seal in its original position aga again in and press it into the seal groove. Suck the seal back to starting position.
VBS
86
Maintenance 6.3 6. 3 Attention
Repl Replac acin ing g the the door door seal seal
To be performed by properly instructed maintenance personnel only.
If the the door door se seal al is st stro rong ngly ly de defo form rmed ed or de defe fect ctive ive,, it mus mustt be repl replac aced ed by a ne new w seal seal.. To replace the door seal proceed as follows:
remove the sealing from the groove
insert the new sealing chap. 5.3.1
6 .4
Cleaning
6.4.1 6.4 .1
Inte Interi rior or walls walls
The The usef useful ul life life and and sa safe fety ty of the thein inte teri rior or wa walls lls of the thepr pres essu sure re ve vess ssel el ca cann be co cons nside ide-rably enhanced by regular care and maintenance if suitable precautions are taken. Note that the surface of the interior walls should always be metallic bright. Should the int Should interi erior or wal walll after len lengthy gthy us usee bec become ome grey grey or slig slightly htly spo spotty tty the theyy mus mustt be cleaned. Rusting (loose or in the form of foreign deposits) can lead to the pressure vessel being ruined. Such rusting must therefore be removed without delay. This This is done done – on cham chambe bers rs ha havin vingg wa walls lls th that at are are shotshot---blast blasted ed wi with th ste steel el ba balls lls (d (dull ull surfacefinish)–bymeansofacommerciallyavailablestainlesssteelcleaningagent (duly observe the manufacturer’s instructions for use). Application is best done with a stiff plastic brush. After such treatment the interior walls of the chamber must be thoroughly rinsed clean with cold water. 6.4.2 6.4 .2
Exte Extern rnal al ca care re
We rec recomme ommend nd the Ult Ultra ra pur D stainle stainless ss steel steel cle cleane anerr (A (Art. rt. No No.054 .054430 43088---3921) 3921) for the sta stainle inlessss---steel steel fro front nt pan panell elling. ing.This This is ava availa ilable ble from from MMM MMM.. Spr Spray ay it spa sparin ringly gly on the surface or on a cloth and spread over the polished surfaces. The touch screen can be cleaned with a soft cloth and a gentle detergent. To clean the touch screen while the machine is on, the sensitivity of the touch screen must be deactivated first:
Operating manual Selectomat PL
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Maintenance press this button
touch the pass word field and enter the user password in the numeric pad: 1289
confirm the entry
confirm the pass word
touch the button Wipe
The touch screen is now deactivated for 30 seconds and can be wiped clean. The remaining time of this function is shown on the screen.
quit the menu 6.4.3 6.4. 3
Compon Component ent ro room om
We recommend to clean and disinfect the machine interior spaces thoroughly, as just a few dust is sufficient to increase the amount of germs. Every three three months the inte interior rior space space of the unit is to be clean cleaned ed with an indust industrial rial vacuum cleaner fitted with a disposable (paper) dust bag. Afterwards all systems components are to be disinfected by an approved disinfectant spray.
6 .5
Disposal
Upon termina Upon termination tionof of the thelif lifee cyc cycle, le, the theSele Selecto ctomat matPL PLste steril rilize izerr canbe dulydispo dulydisposed sed of by MMM. Please contact your MMM customer service.
88
Maintenance 6 .6
Service
We rec recomme ommend nd tha thatt you con conclu clude de an insp inspec ection tion and main mainten tenanc ancee con contra tract ct wi with th our customer service department. Regularr ins Regula inspec pection tion and main mainten tenanc ancee by an exper expertt is the bes bestt possi possible ble guar guarant antee ee for perfect system operation. Repair work
The permissib permissible le main maintenan tenance ce w work ork th that at is to be perf performed ormed by the us user er is limite limitedd to the maintenance and upkeep work described in chapter 6.3 and 6.4 . Repair and inspection at the system may m ay only be performed by our company or by persons authorised by our company. We exp expres ressly sly poin pointt ou outt th that at we do not ac accep ceptt any any lia liabili bility ty for any dam damage age at the system ste m or for for pers person onal al injur injurie iess in co conn nnec ectio tionn wi with th thesy the syste stem, m, if the thesy syste stem m wa wass repa repaiired or serviced by persons that were not authorised by MMM.
Note to the warranty
Please refer to the accompanying warranty declaration, which expressly excludes chemical influences and worn parts from the warranty coverage.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
89
7 Soft Softwar ware e Licen Licence ce Agr Agreem eement ent Please read this licence agreement thoroughly, before using the software. Please read the provisions of this licence agreement (”Licence Agreement”) thoroughly before using the product (as defined hereinafter under § 1). The product includes a software which is licenced by MMM Münchener Medizin Mechanik GmbH Gmb H for exc exclusi lusive ve use acc accord ording ing to the provis provision ionss stip stipula ulated ted below below.. Th Thee lice license nseee is entitled to install or use the software only, if the licensee has read the agreement provisions enclosed and agrees to them. As soon as the licensee starts the installation tion or the the use use of the theso soft ftwa ware re or part part of th thee soft softwa ware re,, th this is wi will ll bbee rega regard rded ed as ac acce cepptance tan ce of all pr provi ovision sionss of this lice licence nce agr agreem eement ent,, the wa warra rranty nty,, the limit limitatio ationn of liability and all other provisions of this licence agreement. If the licensee does not agree with the provisions of this licence agreement, the licensee is not entitled to use the software. In that case the licensee is obliged to inform MMM Münchener Medizin Mechanik GmbH and to return the software not used including the accompanying documentation within ten (10) days following
the date of purchase.
90
Softwa re Licen Licence ce Agr Agreeme eement nt Software 1
Definitions
”Patches” ”Patch es” refers refers to the rem remova ovall of pro progra gram m bug bugss or faulty faulty fun functio ctions ns of the softwa software re or of the corresponding software code. ”Product” refers to (a) one or more steam sterilizers of the Selectomat PL series or other equipment, that the user may have bought for use with the software from MMM Münchener Medizin Mechanik GmbH or (b) the software itself, if the user has bought exclusively the software. ”Sales contract” refers to the purchase order, the sales contract, or any other ot her document that is the basis of the purchase of the product. ”Software ”Softw are”” refersto refersto the thesof softwa tware re dev develo eloped pedby by MMM MMMMün Münche chener nerMed Medizin izinMe Mecha cha-nik GmbH plus the accompanying documentation (electronic or printprint--out), -out), which is ei eithe therr (a) (a) deliv deliver ered ed ona on a da data ta ca carr rrie ierr or or(b (b)) pr prel eloa oade dedd on th thee pr prod oduc uctt (p (pro rovi vide dedd th that at the product is not the software itself). ”Specifica ”Spec ification tion ooff se service rvices” s” refe refers rs to the ffunctio unctionality nality of th thee softw software are and the auxi-
liary functions, if available, described in the product description, provided by MMM either elecronically or as paper printprint--out -out in connection with the software. ”Defined computer system” refers to the surrounding determined in the product description for electronic data processing (EDP), which is responsible for the t he proper functioning of the software. ”Upd ”U pdat ates es”” refe refers rs to a so soft ftwa ware re ve vers rsion ionth that at no lon longe gerr co cont ntai ains ns the thebu bugs gs of the thepr prec eceeding softw software are vers version, ion, or which - withou withoutt any contr contractua actuall obligation obligation - extends the functionality funct ionality of the software software by adding additio additional nal functions functions or other perf performan ormancece-enhancing elements.
2
Scope
MMM Münchener Medizin Mechanik GmbH, Semmelweisstr. 6, 82152 Planegg, Germany (hereinafter called either “licenser” or ”MMM”) herewith grants to user (herinafter called “licensee”) ---- subject to the settlement of the corresponding licence fee and continuous compliance with the provisions of this agreement ---- the non---exclusive, exclusive, non---negotiable negotiable and nottra nottransfe nsferable rable right to use one (1) copy of the so soft ftwa ware re in a ma mann nner er as desc descri ribe bedd be below low,, as far far as th thee pu purc rcha hase se ag agre reem emen entt do does es no nott stipulate otherwise. The use of the software for a purpose other than stipulated in this agreement is not permitted.
Operating manual Selectomat PL
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Softwa re Licen Licence ce Agr Agreemen eementt Software The afore--mentioned afore--mentioned licence agreement is restricted as follows: (a) the software shall sha ll be use usedd in the aut author horise isedd num number berof of use users rs and andin in mac machin hinee---readab readable le for form m only only;; (b) the software must be installed, saved and executed as a whole or in parts only on the def define inedd com comput puter er sys system tem in com complia pliance ncewit withh the ins instru tructio ctions ns for forinst installa allation tion of the licenser; and (c) it is allowed to create one (1) (1) copy of the software ffor or securing and archiving purposes exclusively, provided that this copy is marked with comprehensive copy right annotations including all additional notes to the rights of the the lic licenser enser of th thee softw software are and with tthe he indica indication tion ooff the oorigina riginall ve version rsion.. If the softwa sof tware re is an upd update ate or an add additio itional nal m modu odule le for a sys system, tem, m mac achin hinee or equ equipme ipment, nt, that is already licenced, the licensee is authorised to make only as many copies as this has been approved by the licenser. Provided that the following restrictions are legally acceptable, the licensee is allo wed to use the software only in such a way way,, as it is allowed according to the licence agreement described above; above; the licenser is not allowed (a) to modify the software or parts of the software in any way whatsoever (including, but without limitation by modifying, adapting, translating t ranslating or second---hand hand version), (b) to decompile the
software softwa re orpar or parts ts of the thesof softwa tware re,, (c)to rever reverse se eng engine ineer er or dis disass assemb emble le thesof the softwa tware re or parts of the the softw software are or to tra transfor nsform m the softwa software re in any other w way ay into a human readable format, (d) to transform the software or parts of the software in another operating system, (e) to pass on or make availabe the software or parts of the soft ware to any third party without written consent of the licenser (f) to use the software orpartsofthesoftwarewithoutwrittenconsentofthelicenseronacomputersystem other than the defined computer system or on more than one work station, in net works, on a client client---server server system or on additional mobil mobilee equipment. This This so soft ftwa ware re licen licence ce does does not not ap apply plyto to soft softwa ware re of an anyy thirdpart thirdpartyy an andd do does es no nott inc inc-lude the use of of such sof softwar tware. e. The rig right ht of the licens licensee ee to use suc suchh softw software are is sub ject to regulations stipulated by such third parties.
92
Softwa re Licen Licence ce Agr Agreeme eement nt Software 3
Warranty
Explicit warranty. The licenser grants the first licensee, that (a) the data carrier, on which the software is saved, is free from any manufacturing and material defects at the time of delivery to the licensee and that (b) the software (this does not apply to updates) works in compliance with the specification of services for a period of one one (1) (1) year year from from the the date date of pu purc rcha hase se,, pr prov ovide idedd tha thatt th thee soft softwa ware re is used used ac acco cord rding ing to the preceding licence agreement and that it is used on the defined computer system and in compliance with the provisions determined in the product description relatin relatingg to the ins install tallatio ation, n, use use,, and ope opera ration tion.. The lic licens enser er exp expres ressly sly dis discla claims ims any warranty that the software is free from defects, runs without interruption, meets the expectati expec tations ons of the lice license nseee or wor works ks in com combina bination tion wit withh the har hardwa dware re or sof softwa tware re poducts of any third party, party, or that all program bugs w will ill be removed. In addition to the conditions mentioned above, any defect ---- in order to be sufficiently severe to infrin infringe ge the war warran ranty ty men mention tioned ed und under er item item(b) (b) - mus mustt lea leadd to a dis discr crepa epancy ncy of sof softt ware functions from the specification of services in such a way that the software is unfit to fulfill tthe he purpose determined in tthe he product description ---- provided that
the software is used in accordance with the preceding licence. If the thelice license nseee ca cann cre create atethe thereq requir uired ed fun functio ctionn in an indi indirec rectt way(a so---called called“w “work ork around”), the respective impairment does not present a defect defect which would result in a liability claim claim according to the pr preceding eceding wa warranty rranty.. The sole obligation of the license lice nserr resul resulting tingfro from m the theaf afore oresai saidd wa warra rranty nty con consis sists ts - at thelicens thelicenser’ er’ss ownchoic ownchoicee and costs - in either (a) replacing the data carrier and / or the software in order to makee it cor mak corres respon pondd withthe ess essent ential ialspe specif cifica ication tionss of ser servic vices es (in (inclu cludin dingg thereplathereplacement by a new version or an equal software), or (b) in repairing the software by supplying codes for correction, work around solutions and / or updates, including an updated documentation and other documents, or (c) in cancelling this licence agreement according to § 6 given below and refunding the licence fee upon return of the thesof softwa tware, re,if if the thefeewas feewas sep separa aratelychar telychargedwhen gedwhen the thepro produc ductt wa wass han handed dedove overr. The aforesaid warranty applies to all replaced data carriers and replaced software until until ex expi pira ratio tionn of the initi initial al wa warr rran anty ty pe peri riod od.. The The licen license seee bear bearss the theco cost stss an andd risk riskss of delivery of the software to a location appointed by the licenser.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
93
Softwa tware re Licen Licence ce Agr Agreemen eementt Sof Receiptt of ser Receip servic vices es res resulti ulting ng from from war warran ranty ty.. Sho Should uld the lice license nseee ide identif ntifyy a sof softwa tware re defect def ect,, whi which ch cou could ld ca cause useliab liabilit ilityy act action iondue dueto to the thepre prece cedin dingg warran warranty ty,, thelicens thelicensee ee will immediately stop the use of the software and inform the licenser in writing about the def defect ect w withi ithinn the not notific ificatio ationn per period iod for def defec ects ts and del delive iverr suf suffic ficien ientt docu docu-mentati men tation on for pro proof of of this def defect ect.. The notific notificati ation on pe perio riodd for def defect ectss is nin ninety ety (90) (90) days from date of delivery of the data carrier (for a defect of the data carrier) and six (6) months from date of delivery of the software (for a defect of the software). The written documentation for proof of defect is sufficient, if the licenser is able to rep reprod roduce ucethe the def defect ect ide identif ntified ied by the lic licens ensee. ee. The lice license nseee wil willl enc enclos losee the thecon con-tract tract to all allow ow the thelic licens enser er to det determ ermine inetha thatt the thenoti notific ficati ation on per period iodfor forthe thecor corres respon pon-ding defect has been observed. The licensee will not carry out any modifications or repairs on his or her own or allow that modifications or repair is carried out by any non--authorised non--authorised third party party.. If the licenser so wishes, the licensee will support the license licenserr in an analysin alysingg the rreaso easons ns and circu circumstanc mstances es that have caused caused the defe defect ct and and will will help help to deve develo lopp co corr rrec ectio tionn co code dess an andd the te test sting ing of th them em or to find find a wo workrk-around solution.
Exclusiveness of warranty. The only rights of the licensee in case of software defects,, are fects arethose thosemention mentioned ed explic explicitly itly in the afor aforee---mentioned mentioned war warranty ranty.. The Thesoftw software are is lice licence ncedd wit withh its “as is” proper propertie ties. s. The licens licenser er gra grants nts no oth other er war warran ranty ty or gua gua-rantee except for the preceding explicitly mentioned warranty. This explicit warrant rantyy is valid valid in lieu lieu of al alll othe otherr ex expli plici citt or imp implie liedd wa warr rran antie ties, s, tha thatt ma mayy ex exis istt ei eithe therr actually or due to law l aw,, including promises, stipulations concerning tthe he serviceability, fitness for a certain purpose, satisfactory quality and nonnon--violation -violation of rights, which are explicitly excluded herewith. It is incumbent onto the licensee to select the softw software are tha thatt compli complies es with the lice licensee’ nsee’ss requ requireme irements. nts. The licens licensee ee bea bears rs the full full risk risk for for the theou outpu tputt of the the so soft ftwa ware re,, the there resu sultsach ltsachie ieve vedd wi with th it an andd fo forr thefitnes thefitnesss of the the so soft ftwa ware re for for the the use use inte intend nded ed by th thee lic licen ense see. e. This This al also so ap appli plies es,, if the thelic licen ense serr has been informed of the intended use of the software beforehand. The licenser is exempt from any liability resulting from the aboveabove--mentioned -mentioned explicit warranty, if a defect has been caused by circumstances, which the licenser li censer is not responsible for, including but without limitation to (a) nonnon--observance -observance of the conditi con ditions ons stip stipula ulated ted in the pro produc ductt de descr scripti iption on or doc docume umenta ntation tion for use and opeoperation; (b) violation of the provisions of this licence agreement; (c) unauthorized modification of the software or unauthorized impairment of the software software by the licensee or any third party; (d) errors in the operation of the software caused by employees of the licensee or any third party; (e) effects of systems or programs not su supp pplie liedd by the the licen license serr, or (f) (f) use use on co comp mput uter er syste systems ms ot othe herr tha thann th thee de defi fine nedd co commputer system. If the licenser is not responsible for a defect under this warranty or if the licenser licenser makes additio additional nal expenditur expendituree inc incurre urredd beca because use the licensee licensee ddoes oes not fully comply with the obligations according to § 3 (including, but without limitation to the obligation to support the licenser and to supply the documentation), the
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Softwa tware re Licen Licence ce Agr Agreeme eement nt Sof licenserr is ent license entitle itledd to cha charg rgee the lice license nseee the full full cos costs ts inc incurr urred ed fo forr the aanal nalysi ysiss and removal of the defect according to expenses of time and material at the licenser’s rates valid at that time.
4
Commercial proprietary rights
The licensee licensee is grante grantedd only those righ rights ts of the softw software are that aare re explic explicitly itly mentioned under § 2 of this licence licence agree agreement. ment. The licen licenser ser remain remainss sole propr proprietor ietor of all other rights of the software, including but without limitation to, proprietary right, patent rights, copyright, trademark, trademark, right on trade secre secrets ts and other commer commercial cial protective prote ctive rights rights.. The licensee licensee is not aallowe llowedd to re remove move from, cove cover, r, or mo modify dify the notes about copyright, trademark or other proprietary rights of the licenser on the software. softw are. The licens licensee ee takes all aappro ppropriate priate action to prev prevent ent unauthorise unauthorisedd use use,, co co-pying, pyin g, sale sale or pub publica lication tionof of the thesof softwa tware re and andthe the unautho unauthoris rised ed per permiss mission ion to acc access ess thesof the softwa tware. re.The Thelice license nseee inde indemnif mnifies ies the thelic licens enser er forany los loss, s, dam damage age,, cla claims ims and expenses (including but without limitation to reasonable costs for legal actions),
incurred by the licensee by infringement of the licenser s rights, by the licensee s brea breach chof ofthi thiss licen licenceagre ceagreem emen entt or by th thee licen license see’ e’ss use use ofthis soft softwa warein rein a ma mann nner er not authorised under this licence agreement, and thus holds the licenser harmless.
Operating manual Selectomat PL
010044945-- 71130 / Rev07
95
Softwa re Licen Licence ce Agr Agreemen eementt Software 5
Limitation of liability
In as muc muchh as the the follo followi wing ng is not not in co conf nflic lictt wi with th ap appl plic icab able le la law w, th thee licen license serr is no nott liable for direct or indirect or consequential damage, including but without limitation to, lost profit, not realised cost reduction, data loss or increased costs of the licensee or other financial loss incurred by or in connection with the purchase, the granting grant ing of usag usagee rig rights, hts, the uuse, se, the failure failure of th thee softw software are,, or the ma malfunc lfunction tion during ring the ope operat ration ion of the sof softwa tware. re. The Thepre preced ceding ing limit limitati ation on of liab liabilit ilityy is also also val valid, id, if the licenser has been informed of the possibility of such damage. The licenser is liable liable for for los losse sess and and dama damage ge only only in as far far as the licen license serr ca cann be ch char arge gedd wi with th inten intentt or gross negligence. This limitation of liability applies to all claims for damages, independent of their legal ground including but without limitation to, contractual, pre--contractual, pre-contractual, or contractual---like like claims and claims from unauthorised action. This limitation of liability applies also to all exec executive utive and non---executive executive employees of the licenser and all representatives and vicarious agents of the licenser that are involved in the development, marketing, or delivery of the software. It is the sole duty of the licensee to ensure that the licensee and the licencee’s staff
dispose of the req dispose requir uired ed kno knowle wledge dge to inst install all aand nd / or use th thee sof softwa tware re pr prope operly rly.. The licenser is not liable for any problems or defects resulting from the user’s insufficient knowledge of the software.
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Softwa tware re Licen Licence ce Agr Agreeme eement nt Sof 6
Contract period and termination
This licence agreement shall become effective on the date, when the licensee accepts and acknowledges the terms of this licence agreement. In add additio itionn to oth other er rights rights of can cancel cellati lation on accord according ing to thi thiss lice licence nce agr agreem eement ent,, ea each ch part partyy is al allo lowe wedd to ca canc ncel el this this licen licence ce ag agre reem emen entt wi with th imm immed edia iate te effe effect ct,, if the theot othe herr party essentially infringes a contractual duty, including but without limitation, limi tation, delayin lay in payme payment nt of the the licen licence ce fee, fee, pr prov ovid ided ed th that at th thee pa part rtyy vi viol olat ating ingthe the co cont ntra ract ct do does es not correct the infringement within forty--five forty--five (45) days upon receipt of a written reminder. On termination of this licence agreement, all righs of the licensee to use this soft ware will cease. Within thirty (30) days on termination of this llicence icence agreement, the licensee must return the software to the licenser or destroy it and all copies or partial par tial cop copies ies the lice license nseee has gen gener erate ated, d, all mod modifie ifiedd par parts ts of the softwa software re or inte interrfacess to other progr face programs ams or data data system systemss and - if exist - all saf safety ety devices devices (a (and nd confirm the destruction in writing to the licenser).
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