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Special Considerations:

Dual Port for Model 52200/52301 Upper Body Blankets, 54200 Dual 

Port Torso Blanket 57000 Surgical Access Blanket 

Two hose ports are provided for clinician preference. Place the 

removable hose port card in the hose port that is not being used during 

warming therapy (see Figure D).

D

Head Drape for Models 54000/54200 Torso Blankets, 52200/52301 

Upper Body Blankets and 57000 Surgical Access Blanket

If the patient is intubated and ventilated, lay the head drape over 

the patient’s head and neck (see figure e) otherwise, tuck the drape 

between the channels of the warming blanket, away from the 

patient’s head.

Warning: Do not allow the warming blanket or head drape 

to cover the patient’s head or airway when the patient is not 

mechanically ventilated.

E

Models 52200/52301 Upper Body Blankets (Optional)

Pull the tie-strip tabs, centered along the upper and lower edges of the 

warming blanket. Tie these strips to prevent the inflated blanket from 

lifting away from the patient. To use the upper body blanket with one 

armboard, one half of the warming blanket can be tied off by wrapping 

tape around it or by tucking it beneath the patient (see Figure F).

F

Model 31500 Multi-Access Postoperative and 61000 Full Body 

Surgical Blankets

To use the access panels, tear the uncut tab at the edge of the warming 

blanket. Remove the backing from the tape strip on the center of the 

blanket. Fold the access panel back and press against the exposed 

tape. Pull the panel away from the tape to release (see Figure G).

G

Chest drapes for Model 30500 Chest Access Blanket
Raise the clear plastic drape to provide patient care to the upper 

body area (see Figure H).

H

Please report a serious incident occurring in relation to the 

device to 3M and the local competent authority (EU) or local 

regulatory authority.

Symbol Glossary

Symbol Title

Symbol

Description and Reference

Authorized 

Representative 

in European 

Community

Indicates the authorized 

representative in the European 

Community. ISO 15223, 5.1.2

Batch code

Indicates the manufacturer's batch 

code so that the batch or lot can be 

identified. ISO 15223, 5.1.5

Catalogue 

number

Indicates the manufacturer's 

catalogue number so that the 

medical device can be identified. 

ISO 15223, 5.1.6

Caution

Indicates the need for the user to 

consult the instructions for use for 

important cautionary information 

such as warnings and precautions 

that cannot, for a variety of reasons, 

be presented on the medical device 

itself. Source: ISO 15223, 5.4.4

CE Mark

Indicates conformity to European 

Union Medical Device Regulation or 

Directive.

Date of 

Manufacture

Indicates the date when the medical 

device was manufactured. Source: 

ISO 15223, 5.1.3

Do not re-use

Indicates a medical device that 

is intended for one use or for use 

on a single patient during a single 

procedure. Source: ISO 15223, 5.4.2

Do not use 

if package is 

damaged or 

open

Indicates a medical device that 

should not be used if the package 

has been damaged or opened. 

Source: ISO 15223, 5.2.8

Green Dot

Indicates a financial contribution 

to national packaging recovery 

company per European Directive 

No. 94/62 and corresponding 

national law. Packaging Recovery 

Organization Europe.

Manufacturer

Indicates the medical device 

manufacturer as defined in Medical 

Device Regulation (EU) 2017/745 

formerly EU Directive 93/42/EEC. 

Source: ISO 15223, 5.1.1

Medical Device

Indicates the item is a medical 

device.

Natural rubber 

latex is not 

present

Indicates natural rubber or dry 

natural rubber latex is not present as 

a material of construction within the 

medical device or the packaging of a 

medical device. Source: ISO 15223, 

5.4.5 and Annex B

Non Sterile

Indicates a medical device that has 

not been subjected to a sterilization 

process. Source: ISO 15223, 5.2.7

Unique device 

identifier

Indicates bar code to scan product 

information into patient electronic 

health record

Use-by date

Indicates the date after which the 

medical device is not to be used. 

Source: ISO 15223, 5.1.4

For more information see, HCBGregulatory.3M.com

Summary of Contents for Bair Hugger Outpatient

Page 1: ...36 in 213 x 91 cm Small Lower Body 53700 35 x 24 in 89 x 61 cm Torso 54000 42 x 36 in 107 x 91 cm Dual Port Torso 54200 42 x 36 in 107 x 91 cm Surgical Access 57000 84 x 36 in 213 x 91 cm Full Body S...

Page 2: ...is classified as Class I Normal Flammability as defined by the Consumer product Safety Commission s flammable fabric regulation 16 CFR 1610 Follow standard safety protocols when using high intensity h...

Page 3: ...opean Community Indicates the authorized representative in the European Community ISO 15223 5 1 2 Batch code Indicates the manufacturer s batch code so that the batch or lot can be identified ISO 1522...

Page 4: ...ns quences correspondant aux mentions d avertissement AVERTISSEMENT Indique une situation dangereuse qui si elle n est pas vit e peut entra ner la mort ou des blessures graves MISE EN GARDE Indique un...

Page 5: ...de la temp rature souhait sur l unit de r chauffement R f rez vous au manuel de l utilisateur pour conna tre les sp cifications propres votre mod le d unit de r chauffement Mise en garde recommandatio...

Page 6: ...Mehrfachzugang 31500 84 x 36 in 213 x 91 cm Oberk rper 52200 76 x 24 in 192 x 61 cm XL Oberk rper 52301 84 x 36 in 213 x 91 cm Unterk rper 52500 60 x 36 in 152 x 91 cm Unterk rper klein 53700 35 x 24...

Page 7: ...cher berwachung die Temperatur von Patienten die nicht reagieren nicht kommunizieren und oder die Temperatur nicht sp ren k nnen mindestens alle 15 Minuten oder den vor Ort geltenden Vorgaben entsprec...

Page 8: ...t das Datum an an dem das Medizinprodukt hergestellt wurde ISO 15223 5 1 3 Nicht wiederverwenden Verweist auf ein Medizinprodukt das f r den einmaligen Gebrauch oder den Gebrauch an einem einzelnen Pa...

Page 9: ...aziente con la coperta riscaldante o il telo per il capo e di ostruire le vie aeree quando il paziente non ventilato meccanicamente AVVERTENZA per ridurre potenziali lesioni dovute a caduta del pazien...

Page 10: ...contro il nastro adesivo esposto Estrarre il pannello dal nastro per rilasciarlo vedere la Figura G Teli torace per coperta di accesso al torace modello 30500 Sollevare il telo di plastica trasparente...

Page 11: ...de gesti n de la temperatura 3M Bair Hugger est dise ado para prevenir y tratar la hipotermia Asimismo este sistema de gesti n de la temperatura puede utilizarse para proporcionar confort t rmico a l...

Page 12: ...ca Bair Hugger antes de aplicar la terapia de calentamiento 3 Introduzca el extremo de la manguera de la unidad de calentamiento Bair Hugger en el puerto de la manguera consulte la figura C Realice un...

Page 13: ...2500 60 x 36 in 152 x 91 cm Onderlichaam klein 53700 35 x 24 in 89 x 61 cm Romp 54000 42 x 36 in 107 x 91 cm Romp dubbele opening 54200 42 x 36 in 107 x 91 cm Chirurgische toegang 57000 84 x 36 in 213...

Page 14: ...bovenop de pati nt zodat de deken de huid van de pati nt raakt afbeelding A 2 Verwijder indien van toepassing de beschermfolie van de kleefstrip en bevestig de warmtedeken aan de pati nt afbeelding B...

Page 15: ...0500 72 x 36 in 183 x 91 cm Pediatrisk 31000 60 x 36 in 152 x 91 cm Med flera tkomstpunkter 31500 84 x 36 in 213 x 91 cm Till verkroppen 52200 76 x 24 in 192 x 61 cm XL till verkroppen 52301 84 x 36 i...

Page 16: ...klass I Normal brandfarlighet enligt definitionen i konsumentprodukternas s kerhetskommissions f rordning f r brandfarliga tyger 16 CFR 1610 F lj standard s kerhetsprotokollet n r du anv nder v rmek...

Page 17: ...er att anv ndaren b r l sa bruksanvisningen f r viktig varnande information t ex varningar och f rsiktigheter som av en m ngd olika anledningar inte kan m rkas ut p den medicinska apparaten i sig K ll...

Page 18: ...r lyser og alarmen lyder Tr k varmeenheden ud af stikkontakten og kontakt en kvalificeret servicetekniker Placer ikke patientfastg relsesanordningen dvs sikkerhedsstrop eller tape over varmet ppet Pla...

Page 19: ...r patienten se Figur F Model 31500 T ppe til postoperativ brug med flere adgange og 61000 Helkropst ppe til operationsbrug Hvis adgangspanelerne skal bruges skal b ndet langs kanten af varmet ppet riv...

Page 20: ...en h res Koble fra varmeenheten og kontakt en kvalifisert servicetekniker Ikke plasser en pasientfesteanordning dvs sikkerhetsstropp eller tape over varmeteppet Ikke legg varmeteppet direkte over et d...

Page 21: ...armbrett kan den ene halvparten av varmeteppet bindes bort ved vikle tapen rundt den eller ved stikke den under pasienten se figur F Modell 31500 postoperativt teppe med flere tilganger og 61000 kirur...

Page 22: ...ee vaaratilannetta joka saattaa johtaa kuolemaan tai vakavaan loukkaantumiseen jos tilannetta ei v ltet T RKE HUOMAUTUS Merkitsee vaaratilannetta joka saattaa johtaa liev n tai kohtalaiseen loukkaantu...

Page 23: ...insa S d ilman l mp tilaa tai lopeta hoito kun hoitotavoite on saavutettu jos mittarit havaitsevat kohonneita l mp tiloja tai jos l mp peitteen alla ilmenee haitallinen ihovaste 5 Keskeyt l mp hoito s...

Page 24: ...3 x 91 cm Cir rgica de corpo inteiro 61000 72 x 36 in 183 x 91 cm Indica es de uso O Sistema de Gest o de Temperatura 3M Bair Hugger destinado preven o e tratamento da hipotermia Al m disso o sistema...

Page 25: ...cole a manta de aquecimento no paciente ver Figura B Isso juntamente com boas pr ticas de cobertura cir rgica ajuda a evitar que o ar aquecido flua na dire o do local da cirurgia Advert ncia N o colo...

Page 26: ...Fonte ISO 15223 5 2 8 l 11000 11101 84 x 36 in 213 x 91 cm 30000 84 x 36 in 213 x 91 cm 30500 72 x 36 in 183 x 91 cm 31000 60 x 36 in 152 x 91 cm 31500 84 x 36 in 213 x 91 cm 52200 76 x 24 in 192 x 61...

Page 27: ...36 in 107 x 91 cm 57000 84 x 36 in 213 x 91 cm 61000 72 x 36 in 183 x 91 cm 3M Bair Hugger 7 Bair Hugger Bair Hugger Bair Hugger 500 700 675 Bair Hugger 200 Bair Hugger 800 Bair Hugger Over temp I 16...

Page 28: ...01 57000 52200 52301 F 31500 61000 G 30500 H 3M ISO 15223 5 1 2 ISO 15223 5 1 5 ISO 15223 5 1 6 ISO 15223 5 4 4 CE ISO 15223 5 1 3 ISO 15223 5 4 2 ISO 15223 5 2 8 Green Dot 94 62 2017 745 93 42 EEC IS...

Page 29: ...om PRODUKT NIEJA OWY Przeciwwskazania ostrze enia i uwagi Wyja nienie znaczenia s w ostrzegawczych OSTRZE ENIE Oznacza niebezpieczn sytuacj kt ra je li nie uda si jej zapobiec mo e spowodowa zgon lub...

Page 30: ...a w Wska nik wizualny znajduje si na rodku ko c wki w a i pomaga w ustaleniu g boko ci na jak nale y w o y w do portu Aby zapewni bezpieczne mocowanie nale y podeprze w UWAGA Poni ej przedstawiono wa...

Page 31: ...cm M ret fels testre 52200 76 x 24 in 192 x 61 cm XL m ret fels testre 52301 84 x 36 in 213 x 91 cm Als testre 52500 60 x 36 in 152 x 91 cm Kis m ret als testre 53700 35 x 24 in 89 x 61 cm T rzsre 54...

Page 32: ...sson a leveg h m rs klet n vagy fejezze be a kezel st Haszn lati tmutat 1 Helyezze a 3M Bair Hugger meleg t takar t k zvetlen l a betegre gy hogy a takar perfor lt oldala az apr lyukakkal rintkezzen a...

Page 33: ...zz j rul st jelzi Packaging Recovery Organization Europe o N VOD K POU IT Vyh van p ikr vka Ambulantn 11000 11101 84 x 36 in 213 x 91 cm Pro cel t lo 30000 84 x 36 in 213 x 91 cm S p stupem k hrudn ku...

Page 34: ...r n kontaminaci produktu UPOZORN N Pro sn en rizika po ru Produkt je klasifikov n jako T da I Norm ln ho lavost jak je stanoveno v Na zen o ho lav ch l tk ch Komise pro bezpe nost spot ebn ch v robk 1...

Page 35: ...lo ar e v robce aby bylo mo n identifikovat ar i nebo polo ku ISO 15223 5 1 5 Objednac slo Zobraz objednac slo v robce aby bylo mo n l ka sk produkt identifikovat ISO 15223 5 1 6 Upozorn n Ozna uje e...

Page 36: ...Bair Hugger s rie 200 Nepou vajte ohrievaciu jednotku prisp sobite n pacientovi Bair Hugger s rie 800 so iadnou ohrievacou prikr vkou Bair Hugger Nepokra ujte s tepelnou lie bou ak sa rozsvieti erven...

Page 37: ...ho okraja ohrievacej prikr vky Uvia te tieto p sky aby ste predi li nadvihnutiu naf knutej prikr vky mimo pacienta Pre pou itie prikr vky pre horn as tela s jednou podlo kou pre horn kon atinu m e by...

Page 38: ...ali premrzlo Sistem kontrole temperature lahko uporabljamo pri odraslih in pediatri nih bolnikih IZDELEK NI STERILEN Kontraindikacije opozorila in previdnostni ukrepi Pojasnitev posledic signalnih be...

Page 39: ...i kot je dolo eno v protokolu instituta Prilagodite temperaturo zraka ali prekinite terapijo ko dose ete cilj terapije e so zapisane previsoke temperature ali je pod grelno odejo pri lo do nasprotne k...

Page 40: ...x 36 in 213 x 91 cm Kirurgilise ligip su 61000 72 x 36 in 183 x 91 cm Kasutusn idustused 3M Bair Hugger i temperatuuri reguleerimise s steem on m eldud h potermia ennetamiseks ja ravimiseks Lisaks saa...

Page 41: ...Vooliku otsa keskkoha juures on visuaalne m rk mis aitab vooliku ige s gavuseni sisestada Kindla kinnitamise tagamiseks toetage voolikut M RKUS Lugege altpoolt mida tekkide Bair Hugger kasutamisel sil...

Page 42: ...213 x 91 cm Apak j erme a 52500 60 x 36 in 152 x 91 cm Maza apak j erme a 53700 35 x 24 in 89 x 61 cm erme a 54000 42 x 36 in 107 x 91 cm Dubult ostas korpusa 54200 42 x 36 in 107 x 91 cm irur isk s p...

Page 43: ...r din jums Nelieciet pacienta nostiprin anas ier ci piem ram dro bas siksnu vai lenti p ri sild anas segai Br din jums Nelieciet sild anas segu tie i uz izklied ta elektrodu izk rtojuma Br din jums Ne...

Page 44: ...x 36 in 152 x 91 cm Ma a apatinio k no 53700 35 x 24 in 89 x 61 cm K no 54000 42 x 36 in 107 x 91 cm Dvigubo uosto k no 54200 42 x 36 in 107 x 91 cm Chirurgin s prieigos 57000 84 x 36 in 213 x 91 cm...

Page 45: ...osios antklod s ned kite paciento saugos taiso pvz saugos dir o ar juostos sp jimas ildan iosios antklod s ned kite tiesiai ant dispersinio elektrodo pleistro sp jimas negydykite paciento naudodami ti...

Page 46: ...multiple de acces 31500 84 x 36 in 213 x 91 cm Pentru ntregul corp 52200 76 x 24 in 192 x 61 cm Pentru ntregul corp XL 52301 84 x 36 in 213 x 91 cm Pentru partea inferioar a corpului 52500 60 x 36 in...

Page 47: ...M Bair Hugger partea cu orificii mici direct deasupra pacientului n contact cu pielea acestuia a se vedea figura A 2 Dac este cazul ndep rta i suportul de pe banda adeziv i lipi i p tura nc lzitoare d...

Page 48: ...c un dispozitiv medical care nu trebuie utilizat dac ambalajul a fost deteriorat sau deschis Sursa ISO 15223 5 2 8 Marca Punctul Verde Indic o contribu ie financiar la compania na ional de recuperare...

Page 49: ...54200 42 x 36 in 107 x 91 cm 57000 84 x 36 in 213 x 91 cm 61000 72 x 36 in 183 x 91 cm 3M Bair Hugger Bair Hugger Bair Hugger Bair Hugger 500 700 675 Bair Hugger 200 Bair Hugger 800 Bair Hugger I 16 C...

Page 50: ...00 52301 57000 E 52200 52301 F 31500 61000 G 30500 H 3M ISO 15223 5 1 2 ISO 15223 5 1 5 ISO 15223 5 1 6 ISO 15223 5 4 4 CE ISO 15223 5 1 3 ISO 15223 5 4 2 ISO 15223 5 2 8 94 62 2017 745 93 42 EEC ISO...

Page 51: ...upom 31500 84 x 36 in 213 x 91 cm Gornjeg dijela tijela 52200 76 x 24 in 192 x 61 cm XL gornjeg dijela tijela 52301 84 x 36 in 213 x 91 cm Donjeg dijela tijela 52500 60 x 36 in 152 x 91 cm Malidonjeg...

Page 52: ...postignut terapijski cilj ako se bilje e povi ene temperature ili ako postoji negativan ko ni odgovor pod pokriva em za zagrijavanje Upute za uporabu 1 Postavite perforiranu stranu stranu s malim otvo...

Page 53: ...vor ISO 15223 5 2 8 y 11000 11101 84 x 36 in 213 x 91 cm 30000 84 x 36 in 213 x 91 cm 30500 72 x 36 in 183 x 91 cm 31000 60 x 36 in 152 x 91 cm 31500 84 x 36 in 213 x 91 cm 52200 76 x 24 in 192 x 61 c...

Page 54: ...4200 42 x 36 in 107 x 91 cm 57000 84 x 36 in 213 x 91 cm 61000 72 x 36 in 183 x 91 cm 3M Bair Hugger Bair Hugger Bair Hugger Bair Hugger 500 series 700 series 675 Bair Hugger 200 series Bair Hugger 80...

Page 55: ...52301 57000 E 52200 52301 F 31500 61000 G 30500 H 3M ISO 15223 5 1 2 ISO 15223 5 1 5 ISO 15223 5 1 6 ISO 15223 5 4 4 CE ISO 15223 5 1 3 ISO 15223 5 4 2 ISO 15223 5 2 8 94 62 Packaging Recovery Organi...

Page 56: ...ako se ne izbegne mo e da dovede do smrti ili ozbiljne povrede OPREZ Ukazuje na opasnu situaciju koja ako se ne izbegne mo e da dovede do manje ili umerene povrede Kontraindikacije KONTRAINDIKACIJA Za...

Page 57: ...godite temperaturu vazduha ili prekinite terapiju kada je terapijski cilj postignut ukoliko su zabele ene povi ene temperature ili ukoliko se javi negativna reakcija na ko i ispod deke za grejanje 5 U...

Page 58: ...00 84 x 36 in 213 x 91 cm T m G vde Cerrahi 61000 72 x 36 in 183 x 91 cm Kullan m Endikasyonlar 3M Bair Hugger S cakl k Y netim Sistemi hipotermiyi nlemek ve tedavi etmek i in tasarlanm t r Ayr ca s c...

Page 59: ...nitesi hortumunun ucunu hortum yuvas na tak n bkz ekil C Hortumun yuvaya tam oturmas n sa lamak i in evirerek tak n Hortumun giri derinli ini g stermek i in hortum ucunun orta k sm nda g rsel bir i a...

Page 60: ...3 x 91 cm 31000 60 x 36 in 152 x 91 cm 31500 84 x 36 in 213 x 91 cm 52200 76 x 24 in 192 x 61 cm XL 52301 84 x 36 in 213 x 91 cm 52500 60 x 36 in 152 x 91 cm 53700 35 x 24 in 89 x 61 cm 54000 42 x 36...

Page 61: ...ger 3 Bair Hugger C Bair Hugger 4 3M 15 15 5 52200 52301 54200 57000 D 54000 54200 52200 52301 57000 E 52200 52301 F 31500 61000 G 30500 H 3M EU ISO 15223 5 1 2 ISO 15223 5 1 5 ISO 15223 5 1 6 ISO 152...

Page 62: ...0 60 x 36 in 152 x 91 cm 31500 84 x 36 in 213 x 91 cm 52200 76 x 24 in 192 x 61 cm XL 52301 84 x 36 in 213 x 91 cm 52500 60 x 36 in 152 x 91 cm 53700 35 x 24 in 89 x 61 cm 54000 42 x 36 in 107 x 91 cm...

Page 63: ...ugger Bair Hugger 4 3M 15 15 5 52200 52301 57000 Torso 54200 D Torso 54000 54200 57000 52200 52301 E 52200 52301 F 61000 31500 G 30500 H 3M 5 1 2 15223 ISO ISO 5 1 5 15223 5 1 6 15223 ISO 5 4 4 15223...

Page 64: ...ur dhe t pediatris JO STERILE Kund rindikimet paralajm rimet dhe kujdesi Shpjegimet p r pasojat e fjal ve sinjalizuese PARALAJM RIMET Tregon nj situat t rrezikshme q n se nuk shmanget mund t shkaktoj...

Page 65: ...nitorimin e pacientit 3M rekomandon monitorimin e vazhduesh m t temperatur s baz N munges t monitorimit t vazhduesh m monitoroni temperatur n e pacient ve q nuk kan aft sin t reagojn t komunikojn dhe...

Page 66: ...in 213 x 91 cm 30500 72 x 36 in 183 x 91 cm 31000 60 x 36 in 152 x 91 cm 31500 84 x 36 in 213 x 91 cm 52200 76 x 24 in 192 x 61 cm XL 52301 84 x 36 in 213 x 91 cm 52500 60 x 36 in 152 x 91 cm 53700 35...

Page 67: ...Hugger 500 700 675 Bair Hugger 200 Bair Hugger 800 Bair Hugger I 16 CFR 1610 3 15 15 1 3M Bair Hugger A 2 Bair Hugger Bair Hugger 3 Bair Hugger C Bair Hugger 4 3 15 15 5 52200 52301 54200 57000 D 540...

Page 68: ...rce de 3M utilis es sous licence au Canada 2019 3M All rights reserved Tous droits r serv s Issue Date 2019 07 DV 9063 0014 5 1219 3100023147 3M Deutschland GmbH Health Care Business Carl Schurz Str 1...

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