background image

a

   Large Pediatric Underbody Warming  Blanket - Model 55000 / 

Pediatric Underbody Warming Blanket - Model 55501

INSTRUCTIONS FOR USE

Indications for Use

The 3M™ Bair Hugger™ Temperature Management System is intended 
to prevent and treat hypothermia. In addition, the temperature 
management system can be used to provide patient thermal comfort 
when conditions exist that may cause patients to feel too warm or too 
cold. The temperature management system can be used with adult and 
pediatric patients.

• NOT 

STERILE.

• 

Contraindications, Warnings and Cautions

Explanation of Signal Word Consequences

WARNING:

Indicates a hazardous situation which, if not avoided, could result in 
death or serious injury.

CAUTION:

Indicates a hazardous situation which, if not avoided, could result in 
minor or moderate injury.

CONTRAINDICATION: To reduce the risk of thermal injury:

•  Do not apply heat to lower extremities during aortic 

cross-clamping. Thermal injury may occur if heat is applied to 
ischemic limbs.

WARNING: To reduce the risk of thermal injury:

•  Do not treat patients with the Bair Hugger warming unit hose 

alone. Always attach the hose to a Bair Hugger warming blanket 
before providing warming therapy.

•  Do not allow the patient to lie on the warming unit hose.

•  Do not allow the patient’s arms or legs to rest on either 

hose port.

•  Do not allow the warming unit hose to directly contact the 

patient’s skin during warming therapy.

•  Do not leave neonates, infants, children and other vulnerable 

patient populations unattended during warming therapy.

•  Do not leave patients with poor perfusion unmonitored during 

prolonged warming therapy.

•  Do not place the non-perforated side of the warming blanket 

on the patient. Always place the perforated side (with the small 
holes) directly in contact with the patient’s skin.

•  In the operating room, do not use this warming blanket with 

any device other than a Bair Hugger 500 series, 700 series, or 
675 warming unit.

•  Do not use a Bair Hugger 200 series warming unit in the 

operating room

•  Do not use a Bair Hugger 800 series patient adjustable warming 

unit with any Bair Hugger warming blanket.

•  Do not continue warming therapy if the red Over-temp indicator 

light illuminates and the alarm sounds. Unplug the warming unit 
and contact a qualified service technician.

•  If a securement device (i.e. safety strap, tape) is used, ensure the 

warming channels are not occluded.

•  Do not place the warming blanket directly over a dispersive 

electrode pad.

WARNING: To reduce the risk of patient injury or death due to 
altered drug delivery:

•  Do not use a warming blanket over transdermal 

medication patches.

WARNING: To reduce the risk of injury due to interference 
with ventilation:

•  Do not allow the warming blanket or head drape to cover 

the patient’s head or airway when the patient is not 
mechanically ventilated.

WARNING: To reduce the risk of injury due to patient falls:

•  Do not use a warming blanket to transfer or move the patient.

CAUTION: To reduce the risk of cross-contamination:

•  This warming blanket is not sterile and is intended for single 

patient use ONLY. Placing a sheet between the warming blanket 
and the patient does not prevent contamination of the product.

CAUTION: To reduce the risk of fire:

•  This product 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 heat sources.

CAUTION: To reduce the risk of thermal injury:

•  Do not use if primary packaging has been previously opened or 

is damaged.

CAUTION: To reduce the risk of thermal injury, hyperthermia 
or hypothermia:

•  3M recommends continuously monitoring core temperature. In 

the absence of continuous monitoring, monitor the temperature 
of patients who are incapable of reacting, communicating 
and/or who cannot sense temperature a minimum of every 
15 minutes or according to institutional protocol.

•  Monitor cutaneous responses of patients who are incapable 

of reacting, communicating and/or who cannot sense 
temperature a minimum of every 15 minutes or according to 
institutional protocol.

•  Adjust air temperature or discontinue warming therapy when 

the therapeutic goal is reached, if elevated temperatures are 
recorded or if there is an adverse cutaneous response in the 
warmed area.

Internal Use

Ohrievacia deka

Grelna odeja

Soojendav tekk

Sasilšanas sega

Atšilimo antklodė

Pătură încălzitoare

Обогревающее

 

одеяло

Pokrivač za zagrijavanje

Затоплящо

 

одеяло

Deka za grejanje

Isıtma Battaniyesi

⸈庛嬝

ﺔﺌﻓﺪﺗ

 

ﺔﻴﻧﺎﻄﺑ

Batanije për ngrohje

ќебе

 

за

 

затоплување

Warming Blanket

Couverture de réchauffement

Wärmedecke

Coperta termica

Manta térmica

Warmtedeken

Värmefilt

Varmetæppe

Varmeteppe

Lämpöpeite

Manta de aquecimento

Κουβέρτα

 

θέρμανσης

Koc ogrzewający

Melegítőtakaró

Vyhřívaná přikrývka

PDF @ 70%

Содержание Bair Hugger 55000

Страница 1: ...ecurement device i e safety strap tape is used ensure the warming channels are not occluded Do not place the warming blanket directly over a dispersive electrode pad WARNING To reduce the risk of pati...

Страница 2: ...minimum of every 15 minutes or according to institutional protocol Monitor cutaneous responses of patients who are incapable of reacting communicating and or who cannot sense temperature a minimum of...

Страница 3: ...s curit standards lorsque vous utilisez des sources de chaleur haute intensit MISE EN GARDE afin de r duire le risque de br lures N utilisez pas le produit si l emballage est ouvert ou endommag MISE...

Страница 4: ...zu warm oder zu kalt sein k nnte kann das Temperaturmanagementsystem auch f r den thermischen Komfort des Patienten genutzt werden Das Temperaturmanagementsystem kann bei Erwachsenen und Kindern eing...

Страница 5: ...n dessen Bedienungsanleitung VORSICHT Empfehlungen zur Patienten berwachung 3M empfiehlt die K rperkerntemperatur fortlaufend zu berwachen Bei fehlender kontinuierlicher berwachung die Temperatur von...

Страница 6: ...il rischio di lesioni termiche ipertermia o ipotermia 3M consiglia di monitorare costantemente la temperatura centrale In assenza di un monitoraggio continuo controllare la temperatura dei pazienti c...

Страница 7: ...i n de las palabras de advertencia ADVERTENCIA Indica una situaci n de peligro que si no se evita podr a ocasionar la muerte o una lesi n grave PRECAUCI N Indica una situaci n de peligro que si no se...

Страница 8: ...s pacientes que no puedan reaccionar o comunicarse o que no puedan sentir la temperatura con una frecuencia m nima de 15 minutos o de acuerdo con el protocolo institucional Controle las respuestas cut...

Страница 9: ...ronnen met hoge intensiteit gebruikt LET OP Zo beperkt u het risico op thermisch letsel Niet gebruiken als de primaire verpakking eerder geopend of beschadigd is LET OP Zo beperkt u het risico op ther...

Страница 10: ...01 BRUKSANVISNING Indikationer f r anv ndning 3M Bair Hugger temperaturregleringssystem r avsett att f rhindra och behandla hypotermi Dessutom kan temperaturregleringssystemet anv ndas f r att ge pati...

Страница 11: ...ng av enheten eller st ll in v ntel get f r att avbryta v rmebehandlingen Koppla loss slangen fr n v rmefilten och kasta filten enligt sjukhusets policy Rapportera en allvarlig h ndelse som har intr f...

Страница 12: ...s p en m de s varmekanalerne ikke blokeres 3 Anvend de gennemsigtige afd kninger efter behov til operationen Hovedafd kningen skal l gges over patientens hoved og hals hvis patienten er intuberet og v...

Страница 13: ...n Dette produktet er klassifisert som normalt antennelig i klasse I som definert av den amerikanske etaten Consumer Product Safety Commission sine reguleringer for brannfarlig stoff 16 CFR 1610 F lg s...

Страница 14: ...a EI STERIILI Vasta aiheet varoitukset ja t rke t huomautukset Huomiosanojen merkitykset VAROITUS Merkitsee vaaratilannetta joka saattaa johtaa kuolemaan tai vakavaan loukkaantumiseen jos tilannetta e...

Страница 15: ...ukaisesti Ilmoita laitteen yhteydess ilmenneest vakavasta vaaratilanteesta 3M lle ja paikalliselle toimivaltaiselle viranomaiselle EU tai paikalliselle s ntelyviranomaiselle Symbolisanasto Symbolin ot...

Страница 16: ...mbaixo do colch o ou da mesa para fornecer estabilidade extra 2 Coloque o paciente em cima da manta enquanto ela ainda n o est inflada N o coloque os bra os do paciente atravessados na manta o fluxo d...

Страница 17: ...tivo m dico ou na embalagem de um dispositivo m dico Fonte ISO 15223 5 4 5 e Anexo B N o est ril Indica um dispositivo m dico que n o esteve sujeito a processo de esteriliza o Fonte ISO 15223 5 2 7 Ap...

Страница 18: ...r 6 3 15 15 7 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 90 385 93 42 98 79 ISO 15223 5 1 1 ISO 15223 5 4 5 B...

Страница 19: ...korzystania ze r de ciep a o wysokiej intensywno ci nale y post powa zgodnie ze standardowymi protoko ami bezpiecze stwa PRZESTROGA Aby zmniejszy ryzyko wyst pienia obra e termicznych Nie stosowa w pr...

Страница 20: ...t s gyermek betegek eset n is haszn lhat NEM STERIL Ellenjavallatok figyelmeztet sek s vint zked sek Jelz szavak k vetkezm nyeinek magyar zata FIGYELMEZTET S Olyan vesz lyes helyzetet jelez amely hal...

Страница 21: ...pesek reag lni kommunik lni s vagy a h m rs kletet rz kelni A ter pi s c lt el rve vagy ha emelkedett testh m rs kletet m r illetve ha a meleg tett ter leten nemk v natos b rv laszt szlel v ltoztasson...

Страница 22: ...vku Bair Hugger savou l tku 1 Pomoc lepic ch p sk na spodn stran p ikr vky p ipevn te zah vac p ikr vku ke stolu abyste zabr nili jej mu sklouznut obr zek A a B Bo n chlopn um st n na spodn stran mod...

Страница 23: ...Hugger Nepokra ujte s tepelnou lie bou ak sa rozsvieti erven indik torov svetlo Over temp Nadmern teplota a zaznie alarm Odpojte ohrievaciu jednotku a kontaktujte kvalifikovan ho servisn ho technika A...

Страница 24: ...ES ISO 15223 5 1 1 Zdravotn cka pom cka Informuje o tom e tento v robok je zdravotn ckou pom ckou Bez obsahu pr rodn ho gumen ho latexu Ozna uje e v danej zdravotn ckej pom cke ani v balen zdravotn c...

Страница 25: ...orejo odzivati in ali pri tistih ki je ne morejo zaznavati vsaj na 15 minut ali kot je dolo eno v protokolu instituta Nadzirajte odzive ko e pri bolnikih ki se ne morejo odzivati in ali pri tistih ki...

Страница 26: ...n Kasutusjuhised M rkus Kui tekkida v ib vedelikujooks asetage Bair Huggeri soojendava teki alla imav lapp 1 Kinnitage tekk selle mahalibisemise ennetamiseks laua k lge kasutades soojendava teki alumi...

Страница 27: ...padeves un sazinieties ar kvalific tu servisa tehni i Ja tiek lietota nostiprin anas ier ce piem dro bas siksna lente p rliecinieties vai sild anas kan li nav nosprostoti Nelieciet sild anas segu tie...

Страница 28: ...uma 21 Feder lo noteikumu kodekss CFR sek 801 109 b 1 Unik lais ier ces identifikators Nor da sv trkodu ko izmantot produkta inform cijas iesken anai elektroniskaj pacienta medic nas kart Izmantojams...

Страница 29: ...ra yta arba jei vyksta nepageidaujama odos reakcija ildomoje srityje 7 Pagal naudojam ildymo renginio model i junkite rengin arba junkite bud jimo re im kad nutrauktum te ildymo terapij Atjunkite arn...

Страница 30: ...u mas pentru a oferi stabilitate suplimentar 2 A eza i pacientul deasupra p turii c t timp aceasta nu este umflat Nu a eza i bra ele pacientului pe deasupra p turii fluxul de aer poate fi restric iona...

Страница 31: ...v medical care nu a fost supus procedurii de sterilizare Sursa ISO 15223 5 2 7 Numai cu prescrip ie medical Indic faptul c legisla ia federal din S U A limiteaz v nzarea acestui dispozitiv c tre sau l...

Страница 32: ...3 15 15 7 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 90 385 93 42 98 79 ISO 15223 5 1 1 ISO 15223 5 4 5 B ISO 15223 5 2...

Страница 33: ...eno PA NJA Za smanjenje rizika od toplinske ozljede hipertermije ili hipotermije 3M preporu a kontinuirano nadziranje temperature jezgre U odsustvu kontinuiranog nadzora pratite temperaturu pacijenata...

Страница 34: ...icinski proizvod u EU Proizvo a Ozna ava proizvo a a medicinskog proizvoda prema definiciji u EU Direktivama 90 385 EEZ 93 42 EEZ i 98 79 EZ ISO 15223 5 1 1 Medicinski proizvod Ozna ava da je stavka m...

Страница 35: ...5 7 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 Organization Europe 90 385 93 42 98 79 ISO 15223 5 1...

Страница 36: ...tra nje temperature Ukoliko kontinuirano pra enje nije mogu e potrebno je pratiti temperaturu pacijenata koji nisu u mogu nosti da reaguju komuniciraju i ili koji ne mogu da osete temperaturu najmanje...

Страница 37: ...izin vermeyin Is tma tedavisi s ras nda yenido an bebek ocuk ve di er korunmas z hastalar g zetimsiz b rakmay n Uzun s reli s tma tedavisi s ras nda perf zyonu zay f olan hastalar s rekli izleyin Is t...

Страница 38: ...223 5 1 2 Seri kodu Seri veya lotun tan mlanabilmesi i in reticinin seri kodunu belirtir ISO 15223 5 1 5 Katalog numaras T bbi cihaz n tan mlanabilmesi i in reticinin katalog numaras n belirtir ISO 15...

Страница 39: ...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 90 385 EEC 93 42 EEC 98 79 EC ISO 15223 5 1 1 ISO 15223 5 4 5 B ISO 15223 5 2 7 Rx CFR 21 801 109 b 1 ISO 15223 5...

Страница 40: ...tur 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...

Страница 41: ...ndodhen n pjes n e poshtme t modelit 55000 mund t futen n n dyshek ose n n tavolin p r t siguruar m shum q ndrueshm ri 2 Vendoseni pacientin mbi batanije kur ajo nuk sht e fryr Mos i vendoseni krah t...

Страница 42: ...Tregon nj pajisje mjek sore q nuk i sht n nshtruar nj procesi sterilizimi Burimi ISO 15223 5 2 7 Vet m me rekomandim mjek sor Tregon se Ligji federal i Shteteve t Bashkuara e kufizon k t pajisje p r s...

Страница 43: ...er Bair Hugger 6 3 15 15 7 3 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 90 385 93 42 98 79 ISO 15223 5 1 1 ISO 15223 5 4 5...

Страница 44: ...Bair Hugger logo are trademarks of 3M Used under license in Canada 3M Bair Hugger et Bair Hugger logo sont des marques de commerce de 3M utilis es sous licence au Canada 2019 3M All rights reserved To...

Отзывы: