Eс Декларация Соответствия - ENBIO S Manual De Usuario

13. EС ДЕКЛАРАЦИЯ СООТВЕТСТВИЯ
EC Declaration of Conformity
Company: Enbio Group AG, Eichengasse 3, 4702 Oensingen, Switzerland
declares with sole responsibility, that medical devices: STEAM STERILIZER
(model):
ENBIO S
ENBIO PRO
complies with provisions of Council Directive 93/42/EEC of 14 June 1993 on medical devices (as
amended). The device has been classified in Class IIb in accordance with rule 15 of Annex IX of the
abovementioned Directive
Conformity assessment has been carried out in accordance with Annex II without point 4 of the
above Regulations.
The conformity assessment has been conducted by the Notified Body No. 2274
TUV Nord Polska Sp. z o.o.
ul. A. Mickiewicza 29, 40-085 Katowice, Poland
Sebastian Magrian
Oensingen
17.01.2020
President of the
Board of Directors
Version: 03_01.2020
209
Simon Schaefer
Member of the Board
TERMS OF WARRANTY
1. Enbio Technology Sp. z o.o. hereinafter referred to as Guarantor guarantees the longevity of the machine, when operating in accordance
with the instructions contained in the Manual, on the terms presented below.
2. Duties which result from the warranty shall be fully performed by the Guarantor or service designated by him.
3. The warranty period is 2 2 4 4 m m o o n n t t h h s s from the date of sale. The date of sale is defined as the date of purchase stated on the invoice issued by
the Guarantor or an authorized distributor. Information on the current list of distributors is available at the office of the Guarantor POLAND
8C Sportowa Street, 81-300 Gdynia or at +48 537 441 515.
4. Additional equipment supplied by the Guarantor, which is not an integral part of the device is subjected to warranty of its producer.
5. The provision of warranty does not change the warranty period.
6. The warranty for replaced parts terminates with the expiration of the warranty of the device.
7. The warranty covers:
a) The manufacturer warrants for the defects resulting from the fault of the manufacturer, construction defects in materials and
parts, workmanship errors, assembly and repair costs, supply and replacement of these parts.
b) The Guarantor will endeavor to remove the defect or damage revealed during the warranty period will be removed within 48
hours from the date of delivery to the service. In exceptional cases, the period may be extended if the repair requires a bringing
parts or components from suppliers.
c) The performance of the warranty depends solely on the decision of the Guarantor.
d) The replaced parts shall become the property of the Guarantor.
e) The decision of the employee of t t h h e e G G u u a a r r a a n n t t o o r r , regarding the causes and guilty party of such damage is binding for t t h h e e U U s s e e r r .
The user has the right to submit within 14 days different assessment by a qualified appraiser.
8. The warranty expires and the Guarantor shall not be liable for any damage or malfunctioning of the equipment caused by:
- Faulty use, poor maintenance, adjustment or operation inconsistent with the guidelines contained in the User Manual
- By bad exploitation is meant in particular the use of water other than distilled / demineralized water.
- Carrying out modifications, alterations, repairs, or replacement of parts in-house, without the consent of the Guarantor.
I I n n t t h h e e c c a a s s e e o o f f r r e e m m o o v v a a l l o o r r d d a a m m a a g g e e t t o o t t h h e e w w a a r r r r a a n n t t y y s s t t i i c c k k e e r r o o n n t t h h e e d d e e v v i i c c e e h h o o u u s s i i n n g g , , t t h h e e G G u u a a r r a a n n t t o o r r m m a a y y r r e e f f u u s s e e t t o o p p r r o o v v i i d d e e w w a a r r r r a a n n t t y y s s e e r r v v i i c c e e s s . .
9. T T h h e e w w a a r r r r a a n n t t y y d d o o e e s s n n o o t t c c o o v v e e r r parts subjected to regular wear and tear, consumables.
10. The warranty does not cover damages caused by the machine stoppage while waiting for warranty repair and damage to the property, both
direct and indirect ones.
11. Sales document is a document which authorizes the provision of warranty.
12. Claims must be submitted to the Guarantor by phone or in writing. Telephone notification must be confirmed in writing to the Application
Form and should include:
- The type and device series' number
- The date of sale and the name of the seller
- Warranty period
- The exact address where the device is operating (company name, phone, the person responsible)
- The type of damage, symptoms of abnormal operation and the names of damaged parts if possible
13. Costs arising due to unjustified complaints shall be covered by the party consisting complaint. The Guarantor has the right to refuse to
perform warranty services if the buyer refrains from settling payments for prior service.
14. In matters not covered by the provisions of warranty the provisions of the Civil Code will be applied.
15. The buyer and the Guarantor unanimously agree to exclude the liability of the Guarantor of guarantee rights for defects of the device.
16. It is a prerequisite to maintain the warranty protection by compliance with service maintenance deadlines.
The service must be performed after every 2000 sterilization processes. The device is equipped with a count of the number processes
carried out. Information about the rules and service fees is available at www.enbiogroup.eu
ENBIO TECHNOLOGY Sp. z o.o. , 8C Sportowa Street, 81-300 Gdynia, Poland
e-mail: serwis@enbiogroup.eu, tel. + 48 (58) 731 96 31
www.enbio-group.com/pl
KRS 0000214555, REGON 191317763, NIP 958-09-82-035
v. 01.06.2019
Signature and stamp of the Guarantor:
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