Specifications

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DECLARATON OF CONFORMITY „CE“

In accordance to the following directives

97 / 23 / EG for equipment under pressure

used modul: A

Type and model of products;

Autoclave Type : KL – 5 - 3

Autoclave Type : KL – 7 - 3

Autoclave Type : KL – 12 - 2

It is declared that the above mentioned products in conception and

type of construction, also in the mode of design traded by us, meet the

above directives.

This declaration is going to loose its validity in case of changes not

agreed by us.

Used harmonised regulations:

DIN EN 10028 - 7

Used national regulations/technical specifications:

AD – Merkblatt A 2

ADOLF WOLF SANOclav

Bad Überkingen , 07.01.2003

Adolf Wolf .

Directing Manager

Summary of content (10 pages)

PAGE 1
DECLARATON OF CONFORMITY „CE“ In accordance to the following directives 97 / 23 / EG for equipment under pressure used modul: A Type and model of products; Autoclave Type : KL – 5 - 3 Autoclave Type : KL – 7 - 3 Autoclave Type : KL – 12 - 2 It is declared that the above mentioned products in conception and type of construction, also in the mode of design traded by us, meet the above directives. This declaration is going to loose its validity in case of changes not agreed by us.
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Table 8: Survey of the inspection, maintenance and cleaning work Inspection Rubber gasket of the vessel lid Visual inspection befor each sterilization process: Ensure that the gasket is intact before starting! Visual inspection befor each sterilization process: Valves Watch for grime! Heater Monthly visual inspection: Watch for scaling! Autoclave The autoclave must be checked every 2-3 years by the manufacturer! Recalibrate the temperature and pressure indicator yearly.
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4 Optional extras: Media sensor The media sensor can only be used in conjunction with the MCS control (see fig.2 page 23) WARNING: Do not open the exhaust steam valve after the sterilization of liquids (media) due to the danger of delayed boiling. Allow the autoclave to cool down naturally.
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1 Safety Instructions „SANOclav" stands for state-of-the-art small-batch autoclaves (small sterilizers). All safety-technical aspects, in so far as they are within the manufacturer's sphere of control, have been taken into account. The series KL and TKL autoclaves are insufficiently equipped for sterilisation of medical products within the meaning of the European Guideline 93/42/CCE and are therefore not suitable.
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WARNING: Transport and installation: 1. Fill the vessel with at least 1½ litre of water, but never more than ¾ of the specified maximum vessel volume. The autoclave must never run dry. 1. Ensure that the room is well illuminated (at least 300 Lug). Incorrectly read measured values can result in damage to the sterilization product or inadequate results. 2. Charge and close the autoclave in the manner described in Chapters 2.6.1-1. 2.
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8. In case of sterilization of adhesive fluids an Operating Test of the Safety Valve has do be made before and after the sterilization (see chapter 6.2) 2.7 Operation of small-batch autoclaves, type „TKL-MCS“ 9. In case of sterilization of fluids (in open containers) we recommend the use of a media sensor (see chapter 4) WARNING: During operation: 1. An autoclave without MCS control must be constantly supervised during the sterilization process.
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B: After sterilizing liquids: 1. Let the autoclave cool down to at least 70°C chamber temperature. Liquid sterilization products will boil over on account of delayed boiling and cause serious burns if the steam pressure is vented instead of allowing the autoclave to cool down slowly. Only open the autoclave, when ⇒ the chamber temperature has cooled down to at least 70°C ⇒ the autoclave has no remaining pressure (0 bar). 2.
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C: After sterilization WARNING: Electromagnetic compatibility: 0 1. To guarantee proper sterilization after a mains failure, the sterilization must be repeated for the set time when the power has returned. 2. Do not complete any changes (e.g. a different power supply cable) without previously consulting the manufacture as this can adversely influence the autoclave's immunity to malfunctions. 2 Details concerning use 2.
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2.2 Transport and installation WARNING: Please observe "Safety Instructions" and "Acceptable Risks" (Chapters 1. and 1.2), but particularly the section "Transport and Installation". The following ambient conditions must be fulfilled to ensure optimal autoclave operation: • Ensure good lighting conditions. • The base must be level, firm and resistant to heat. • Ensure effective ventilation. • TKL-MCS autoclaves must be connected to a socket with earthed conductor (see Table 3 "Technical Data").
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Do not complete any changes (e.g. a different power supply cable) without previously consulting the manufacture as this can adversely influence the autoclave's immunity to malfunctions.