background image

   

  

 

  

EU Declaration of Conformity 

We, 

Promotal 

22 rue de Saint Denis de Gastines 
53500 Ernée – France 
SRN: FR-MF-000001666 

declare, under our sole responsibility, that the following medical device: 

Commercial name: 

Description: 

Basic UDI-DI: 

 

is a Class I medical device, 

complies with the requirements of 

Regulation (EU) 2017/745

 of the European Parliament and of the 

Council of 5 April 2017, 

meets the applicable European standards applicable, 

bears, as such, the CE marking. 

Year that the CE (Medical Devices) marking was initially affixed: 

 

Signed in Ernée, 
On 26 May 2021 

Rudolf MOURADIAN 
Chairman 

  

Promotal 

22 rue de Saint-Denis de Gas4nes, 53500 Ernée, France 

Tel.: +33 (0)2 43 05 17 76 

Fax : +33 (0)2 43 05 72 00   

www.promotal.com

    

 

                                                                                                                                                                                                                                    

S.A.S.U [one-person simplified joint-stock company] with a capital of €4,290,660 - LAVAL Companies Register Siret [French business registra4on] 

No.: 421 156 720 00011 - VAT No.: FR 67 421 156 720 - APE [business ac4vity sector] Code: 3250 A

EN

  21523 / 21524

Blood Sampling Chair

37014094CHAIPRELVTKJ

2012

Содержание 2152 Series

Страница 1: ...User s Guide Blood Sampling Chair 21523 21524 Model Shown 21523 and 21524 ...

Страница 2: ... Gastines B P 26 53500 ERNÉE Cedex FRANCE Tél 33 0 2 43 05 12 70 Fax 33 0 2 43 05 68 99 internet www promotal com The descriptions and specifications contained in this Operating Manual are deemed correct at the time of printing Promotal however reserves the right to modify its models and its procedures or render them obsolete without notice Before any order we recommend that our customers consult ...

Страница 3: ...n 6 Cleaning protocol 8 Warning 8 General maintenance 8 Disinfection 8 Maintenance Instructions 8 Painted surfaces epoxy polyester fi nish 8 Imitation leather coverings 9 Stainless steel products 9 Chrome fi nished products 9 PVC and ABS products 9 Laminated elements 9 User s Guide Blood Sampling Chair 10 Intended use 10 Authorisation to use 10 Patient weight capacity 10 Features 10 Dimensions 11 ...

Страница 4: ...e arm rest 13 Accessories 14 Head rest 14 Installing the Head rest 14 Lifespan of the Medical Device 15 Obligatory specific maintenance 15 End of the device s useful life 15 Maintenance notebook 16 Note 17 Warranty Information 18 Warranty 18 Obligations 18 Exclusions 18 Exclusive Remedy 18 No Authorization 18 Declaration of Conformity 19 ...

Страница 5: ...nformation marked with this symbol must be read and strictly followed Note Procedure practice or condition Do not sit on the back rest Do not sit on the leg rest Humidity limitation Maximum number of stacked pallets Correct orientation for transportation Atmospheric pressure limitation Temperature limitation Fragile Keep in a dry place Not to use sharp objects Manufacturer General safety sign Refe...

Страница 6: ...people are likely to pass Articles must not be stacked on top of each other Articles must remain in their original packaging until fi nal delivery Conditions of use Dry and temperate area Maximum altitude 2000 m Temperature 10 to 40 C Relative humidity 75 maxi Unpacking Installation When installing remove all staple clips and carefully remove the cardboard packaging Fragile parts of the product up...

Страница 7: ...tive Countries in the EEC should direct all questions incidents and complaints to Promotal s Authorized CE representative listed below Promotal 22 rue de Saint Denis de Gastines 53500 Ernée FRANCE Téléphone 33 0 2 430 517 76 Fax 33 0 2 430 572 00 ...

Страница 8: ...products The electric and hydraulic jacks do not require any particular attention The variable height tables chairs and trolleys are equipped either With arms fi tted with self lubricating articulation rings With telescopic bearing runners In this case they should be lubricated once a year particularly if the runners are noisy with ordinary grease See the exploded drawings for access to the runner...

Страница 9: ...sual solvents benzene methylene chloride white spirits etc as well as domestic or specially prepared industrial products may be used Naturally their use requires certain precautions to be taken because of their flammable and toxic properties Precautions must also be taken to avoid damaging adjacent materials which may be sensitive to their chemical action paints mastics joints etc d Acid products ...

Страница 10: ...portant requirements Authorisation to use Only health professionals doctors caregivers and or qualified members of the technical staff can handle or use the chair Patients and companions must not intervene directly on the chair They must not have access to the chair controls Patient weight capacity Features Steel tube frame Gas spring assisted backrest Epoxy finish Possibility to have chrome epoxy...

Страница 11: ...User s Guide 11 Dimensions Blood Sampling Chair 21523 Blood Sampling Chair 21524 ...

Страница 12: ...12 User s Guide Assembling instruction Caution Re tighten the screws before use Assembling the screws x2 ...

Страница 13: ... hand press on the red handle L1 bringing it up to the backrest then position as desired Once the position is obtained release the handle The arm rest Adjusting the arm rest Caution Re tighten the screws before use Do not lean on the extremity of the armrest when getting off the couch ...

Страница 14: ...N 4 Allen key Accessories 14 User s Guide Head rest reference 30141 01 Installing the Head rest The head rest is placed on the backrest Unscrew the 3 screws already in place on the backrest ...

Страница 15: ...the articulated parts Check the structure did not undergo any deformation Control the various connections Note this information and the date in the maintenance notebook End of the device s useful life Your dealer is responsible for reclaiming and processing this device at the end of its service life Do not hesitate to contact Promotal if necessary We will suggest to you a solution to process this ...

Страница 16: ...OTEBOOK If the product is returned to the retailer or manufacturer please clean and disinfect the material Product Reference Serial number cf label Manufacturing date start date of warranty Date Name of technician Type of intervention corrective action ...

Страница 17: ...User s Guide 17 Note ...

Страница 18: ... to outside causes lightning electric surges floods natural catastrophes impacts etc or to the presence of foreign objects 7 Damage caused by improper hook up or by the power supply damage caused by corrosion or by gradual deterioration of the product 8 Indirect damage related to loss of use and penalties generated by poor performance 9 Aesthetic damage incurred by the outside parts of the equipme...

Страница 19: ...able European standards applicable bears as such the CE marking Year that the CE Medical Devices marking was initially affixed Signed in Ernée On 26 May 2021 Rudolf MOURADIAN Chairman Promotal 22 rue de Saint Denis de Gas4nes 53500 Ernée France Tel 33 0 2 43 05 17 76 Fax 33 0 2 43 05 72 00 www promotal com S A S U one person simplified joint stock company with a capital of 4 290 660 LAVAL Companies...

Страница 20: ...PROMOTAL FRANCE www promotal com DIC21523_2121EN ...

Отзывы: