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Содержание CA-A307E

Страница 1: ...er reading this instruction manual store it in a place that can be easily accessed for later reference Users and or patients are requested to report information about any serious incident that occurs within the EU to the regulating authority of the member country of residence Serious incident means any incident that directly or indirectly resulted in may have resulted in or may result in any of th...

Страница 2: ...or Specifications Specifications Subject to normal manufacturing tolerance Classification Classification as medical device in Europe Class 1 Applicable standards This product is designed and manufactured according to the following standards IEC 60601 1 2005 A1 2012 EN 60601 1 2006 A1 2013 A12 2014 Product lifetime The lifetime of this equipment is typically eight 8 years Lifetime is defined as the...

Страница 3: ...rame and the attachment with 2 long bolts and 2 nuts as shown in figure Fix the outer pipe and the attachment with 2 short bolts and 2 nuts as shown in figure Attach the headboard and lower the back section base Inset the arm into the outer pipe and attach the grip to the arm Tighten the knob bolt and knob nut to fasten the arm Pull down the grip to make sure that the lifting pole is attached firm...

Страница 4: ...benzethonium chloride e g Hiamine 0 05 chlorhexidine gluconate e g Hibitane 0 02 0 05 sodium hypochlorite e g Milton Do not use volatile cleaning fluids such as paint thinner benzene or gasoline and cresol Discoloration or deterioration could result The product cannot be used with an ozone sterilizer or an autoclave sterilizer etc Long term storage Do not place location that tend to be exposed to ...

Страница 5: ...r repair Details necessary when requesting repair Product name model number safety label number Date of purchase Details of fault or problem please provide as much detail as possible Your name organization address and phone number 2 Minimum stock availability period Paramount Bed keeps replacement parts necessary to maintain oxygen cylinder holder performance in stock for at least 8 years after th...

Страница 6: ...5 NOTES ...

Страница 7: ...6 NOTES ...

Страница 8: ...2023 03 ...

Страница 9: ... model refinements Values described for the operation range dimensions angles and weights are subject to normal manufacturing tolerances Except for special cases words such as approximately and about are omitted in this instruction manual to improve readability For any queries contact Paramount Bed see Contact Information as shown below or your distributor Users and or patients are requested to re...

Страница 10: ...tient Intended users Medical professionals Patient target group Refer to the instruction manual for the medical device to be used together with this product UNPACKING THE PRODUCT AND CHECKING THE PARTS After unpacking check that there are no missing or damaged parts If any parts are missing or damaged contact Paramount Bed see Contact Information on p 6 ...

Страница 11: ...hook of the IV pole that weighs more than the load capacity of the hook The load capacity of each hook is 1 kg 2 2 lbs Do not hang any object that weighs more than this load capacity because it may damage the hook resulting in injury Do not use the IV pole in a place where strong electromagnetic fields are present such as near an MRI The IV pole could be magnetically pulled toward MRI equipment re...

Страница 12: ...vices and such accessory is required to be labeled as Medical Device under medical device regulations in Europe EC 562 only In some countries or regions do not use this symbol Manufacturer It may be called Legal Manufacturer or Brand Owner etc This symbol is not applicable in the country of origin Refer to the instruction manual Country of manufacture Made in China Manufacturing site In the countr...

Страница 13: ...Product weight 1 kg 2 2 lbs Materials Supportive bar sliding pipe hook Stainless Hanger top ABS resin Vertical stopper PP resin Medical device to be used together with this product KC 562E 1 KC 562U 2 ALiUS EC 562 A6 Series A5 Series Qualitas Nx Series Environmental conditions Range Transport and storage Operation Temperature 10 to 50 C 14 to 122 F 10 to 40 C 50 to 104 F Humidity 30 to 90 RH 30 to...

Страница 14: ...use by another patient CAUTION Do not use volatile cleaning solutions such as paint thinner benzine or gasoline or cresol Discoloration or deterioration may result Do not use disinfectants other than those listed above Damage or deterioration may result Thoroughly wipe off parts with a damp cloth after using a neutral detergent or sodium hypochlorite Not doing so may cause cracking discoloration o...

Страница 15: ...queries please feel free to contact your distributor or to the following address Contact Information Location in Japan Location in the United States PARAMOUNT BED CO LTD 14 5 2 chome Higashisuna Koto ku Tokyo 136 8670 Japan TEL 81 0 3 3648 2961 FAX 81 0 3 3648 5781 PARAMOUNT BED USA Corporation 95 Argonaut Suite 120 Aliso Viejo CA 92656 Tel 949 328 9766 Fax 949 328 9752 E mail contact paramountbed...

Страница 16: ...Instruction manual edited by Torindo Co Ltd 2023 03 ...

Страница 17: ... patients are requested to report information about any serious incident that occurs within the EU to the regulating authority of the member country of residence Serious incident means any incident that directly or indirectly resulted in may have resulted in or may result in any of the following Death of a patient user or other person Serious temporary or permanent adverse effects on the health of...

Страница 18: ...use the oxygen cylinder Intended users Medical professionals Patient target group Refer to the instruction manual for the medical device to be used together with this product Part names and checking parts After unpacking check that there are no missing or damaged parts If any parts are missing or damaged contact Paramount Bed see P 8 or your distributor For details on the product symbol see p 7 ...

Страница 19: ...may be damaged or deformed Do not attach the oxygen cylinder holder to the foot end of medical device When the medical device is operated with reverse trendelenburg there is a risk that the foot may be caught between the oxygen cylinder holder and the floor Do not repair or modify by yourself Doing so may create an unintended gap resulting in accidental injury When using the oxygen cylinder use ca...

Страница 20: ...med Before use make sure that the knob bolt is firmly tightened If it is not tightened enough the oxygen cylinder may be unstable and oxygen supply may be interrupted When using the oxygen cylinder use caution not to allow the flowmeter etc to come into contact with a person or object around the medical device If a contact happens the flowmeter or the oxygen cylinder holder may be damaged resultin...

Страница 21: ... the floor 2 Align a groove of the oxygen cylinder holder with the bolt in the bottom of the optional accessory attachment hole Use the oxygen cylinder holder at position A in the figure on the left If used in position B or C the medical device may become unstable fall over and cause injury Do not install the IV pole on the right side left side of the medical device when using the oxygen cylinder ...

Страница 22: ...holder counterclockwise to loosen it 4 Slowly insert the oxygen cylinder into the oxygen cylinder holder and then turn the knob bolt clockwise to tighten it and firmly secure the oxygen cylinder 5 Gently shake the oxygen cylinder to make sure that it does not wobble ...

Страница 23: ...her patient Do not use volatile cleaning solutions such as paint thinner benzine or gasoline or cresol Discoloration or deterioration may result Do not use disinfectants other than those listed above Damage or deterioration may result Thoroughly wipe off parts with a damp cloth after using a neutral detergent Not doing so may cause cracking of the resin If the oxygen cylinder holder is stained wip...

Страница 24: ...mbol Description Serial number Authorised representaive in the european community Model number CE mark Lot number See the instruction manual Manufacturer It may be called Legal Manufacturer or Brand Owner etc This symbols is not applicable in the country of origin Refer to the instruction manual Country of manufacture Made in India Manufacturing site In the country of origin the site acts as the m...

Страница 25: ... original functions of products is 8 years after discontinuation of manufacturing 2 When you are not sure about the after sales service For any queries please feel free to contact your distributor or to the following address Contact information Location in Japan Manufacturer Location in India Manufacturing premises PARAMOUNT BED CO LTD 14 5 2 chome Higashisuna Koto ku Tokyo 136 8670 Japan TEL 81 0...

Страница 26: ...MEMO 9 ...

Страница 27: ...MEMO 10 ...

Страница 28: ...Made by PARAMOUNT BED Co Ltd 2023 03 ...

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