Lifewarmer Quantum User Manual
™
Blood & Fluid Warming System
___________________________
USER MANUAL
™
Distributed by
35 Tedwall Ct. • Greer SC 29650 • USA
™
™
Blood & Fluid Warming System
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
It is important that users read and understand all information contained in this
manual concerning the intended use and proper operation of the Quantum
Blodd & Fluid Warming System. This manual is not intended as a substitute for
formal training in the use of intravenous administration systems, which may be
required by local, regional, or state protocol. Consult your local medical director
or governing agency for further information and requirements. For questions
concerning this manual or the device, contact Life Warmer, Inc.
Contact Us:
If you have questions regarding the use of the Quantum Blood and Fluid
Warming System or any component, please contact North American Rescue at
888-689-6277.
Life Warm er, Inc
Addiso n, TX 75001
972-908-9808
USA
lifeline@lifewarmer.com
ZZ-1098 • RE V050619
Distributed by
35 Tedwall Ct. • Greer SC 29650 • USA
-3-
LIFEWARMER
REF
GLOSSARY OF SYMBOLS
The following symbols may appear on components or in information rel ated to the Quantum device.
™
Symbol Reference Title/Meaning
ISO -2492
SO 7000-1051 Do Not Reuse
I
ISO 7000-3832 Gravit y type
EN 50419
ISO 7000-043A Caution
ISO 15223 –
5.4.5
ISO 700 0-1641 Operating Instructions; eIFU
ISO 7010-M002 Follow Instructions for Use
ISO 7000-2724 Non-pyrogenic
ISO 7000-3079 Open he re
2
STERILIZE
ISO 7000-2608 Do n ot reste rilize
ISO 7000-0632
ISO 7000-2621
MDD
93/42/EEC
IEC 60086 -4
IEC 60086 -4
Batch Co de/
Manufacturer’s Lot
WEEE whee led bin
Recyle electronic equ ipmen t;
Do Not Throw in Trash
Not made w ith natu ral rub ber
Temperature limit s; Limi ts for
limit ation; R ange wh ich devi ce
latex
safe device exposure
Atmospheric pressure
can be safely exposed
CE Marks
Signies European technical
conformity
DO NOT disassem ble
(batte ry)
Do NOT inci nerate
(batte ry)
Symbol Reference Title/Meaning
20
EC REP
ISO 7000-
2493
ISO 7000-
2607
21 CFR Par t
801.109
ASTM F-2503
IEC 60417-
5333
BS EN 15986 -
4.2
ISO 7000-
2501
ISO 7000-
3082
ISO 7000-
2497
ISO 7000-
6049
ISO 7000-
2726
ISO 7000-
2620
BS/EN 1041
N/A
IEC 60086 -4
Catalogue Number
Use-by d ate;
Date afte r which the device is
not to be us ed
Caution: Fede ral (USA) law
restri cts this device to sale byor
on the ord er of a physi cian
MR Unsafe;
Device known to pose hazards in
all MR environme nts
Type BF Appli ed Par t
Non-DEHP
Does not contain the pht halate
plasticizer DEHP
Sterilized usin g ethylene oxide
Device Manufacturer
Date of manufacture
Country of manufacture
Numbe r of drops p er mlli litre
Humidity limitation;
Range wh ich me dical d evice can
be safely ex posed
Author ized repre sentative in the
European country
Global Trade Identicat ion
Numbe r; deno tes proximate UDI
barcode
Do NOT crus h
(batte ry)
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TABLE OF CONTENTS
LIFEWARMER
Prescribing Information
Indications for Use .........................................................................................................................6
Warnings ..........................................................................................................................................6-7
Precautions ..........................................................................................................................................7
Intended Users & Use Environments ......................................................................................8
Quantum System Description
Device Description ........................................................................................................................9
Quantum System Components ..........................................................................................9
Quantum System Operation
Thermal Infusion Set (TIS) .................................................................................................... 10
Thermal Transfusion Set (TTS-B) ....................................................................................11
Charging/Connecting the Battery ................................................................................ 12
• Charging the Battery .................................................................................................... 12
• Checking Battery Charge Status ........................................................................ 12
• Connecting the Battery to the Controller ................................................... 12
• Important Battery Use Information .................................................................. 12
Connecting the Controller ....................................................................................................13
• Connecting the Controller to the TIS or TTS-B Tubing .....................13
• Disconnecting Components/Discontinuing Use ..................................13
Enabling/DIsabling Audible Alert System ...............................................................14
Instructions for Performing Manual Test of Audible Alert ...........................14
Sterility Status .........................................................................................................................................15
Sterile Components....................................................................................................................15
Single-Patient Use and Non-Sterile Reusable Components ...................15
Cleaning and Disinfecting ............................................................................................................15
Visual/Audio Indicators
User interface: Table of visual and audio indicators ................................ 16-17
Technical Specications ........................................................................................................18-19
Essential Performance .............................................................................................................18
System Information/Safety Classication ................................................................18
Performance .....................................................................................................................................18
Component Specications .................................................................................................. 19
Operating, Storage & Distribution Conditions ...........................................................20
EMC Compliance Statement .......................................................................................................21
APPENDIX ....................................................................................................................................................22
Troubleshooting Guide .................................................................................................. 22-23
Quantum Response by Temperature Table ...........................................................23
Glossary of Terms ....................................................................................................................... 24
Quantum Components List .........................................................................................24-25
Warranty .............................................................................................................................................26
™
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PRESCRIBING INFORMATION
LIFEWARMER
INDICATIONS FOR USE:
The Qua ntum™ Bloo d & Fluid War ming System is ind icate d for warm ing blo od, blo od produ cts an d intrave nous
soluti ons pri or to administ ratio n in adult p atients. It i s intend ed for us e by healthcare professionals in hospital, c linical,
eld and t ransport environm ents to h elp preve nt hypothermia.
WARNINGS:
For the safe opera tion of the Quantum System,
•
all instructi ons, warnings and pre cautions
in this document must b e followed . Failure
to follow instructions fo r proper use may
result in d evice malfunction or injury.
Only the uid path and area s under protect ive
•
end cap s are STERILE. If end protectors
are not in place, DO NOT USE.
DO NOT pla ce tubin g sets or protect ive
•
end cap s in a sterile eld .
The TIS/ TTS -B is for S INGLE PATIENT USE ONLY.
•
DO NOT RES TERILIZE.
The Qua ntum Thermal Infusio n Set (T IS) IS NOT
•
for stan dalon e use with blood or blood product s.
A RED LED stro be and sustai ned audible ale rt on the
•
batter y indicates a ui d over-temperature condit ion
which can result i n hemolysis of blo od and e levatio n
of touch te mpera ture of the t hermal tubin g.
The over-temperatu re Audib le Alert System
•
may be man ually disable d. Ensu re that the
Audible Alert Sys tem is alway s enabled
unless a t actical haz ard is posed.
Repla ce Quan tum Transfu sion ( TTS-B) and I nfusi on
•
Sets ( TIS) in accordan ce with CURRENT A ABB/
CDC guidelin es and/or institutional p rotocol s.
All IV ui d bags mu st be vented of air p er IV ui d
•
manufa cturer s’ direct ions prior to co nnect ing to tub ing
set. Ca re must b e taken to e nsure th ere is not sucient
air in the uid bag and lin es to cau se an air e mbolism.
DO NOT ax, p lace or bind th e therm al (heated)
•
portion of the thermal tubin g directly to a patient.
It is recommend ed that t he Cont roller, Bat tery, and
•
Charger be surfaced cleaned and dis infecte d after
each pat ient us e following the instruc tions i n this
manual or accord ing to st andard insti tution al protocol.
DO NOT touch the Bat tery pins and
•
the pati ent at th e same time.
Warning: Use of thi s equipment ad jacen t to or
•
stacke d with other equ ipment shoul d be avoide d
ecaus e it could re sult in imprope r operation . If
b
such use i s necessar y, this equ ipmen t and the o ther
equipment should be observed to verif y that they are
operating normally.
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The Qua ntum Syste m (including Therma l
•
Tubing TIS an d TTS-B) is MR UNSAFE .
The Qua ntum is in tende d for gravity admi nistration .
•
However, performan ce testi ng has b een
conduc ted in accordance with IS O 1135 -5 for
single u se tran sfusi on set s with pre ssure in fusio n
and foun d to be mec hanic ally st able. Th us,
the clinician may apply re asonable pres sure
to the infusate ba g if it is determin ed that
increa sed ui d ow is clinical ly indicated.
DO NOT attempt to use t he Quantum Syste m
•
components , inclu ding tubing sets (TI S,
TTS- B), Controller, Battery, or Charger wi th
uid war ming devices/component s from oth er
manufa cturer s. They a re not com patible.
DO NOT attempt to use chargin g device s, power
•
cables o r component s from oth er manu facturers
with the Quantu m System co mponents. They
are not com patib le and pose a safet y hazard.
DO NOT attempt to sterilize, au toclave
•
or submerge the C ontrol ler, Batte ry, or
Cha rger. Surface clean/disinfect only.
There are n o user-se rviceable parts i nclud ing the
•
Batter y. For all matters concernin g funct ionality
and ser vice, contact Life Warme r, Inc.
DO NOT attempt to ope n or access the
•
Controller, Batte ry, or Charger. Doin g so may
damage the components and /or result in
device ma lfunc tion, f ailure o r injur y.
DO NOT attempt to mod ify any c ompon ent
•
of the Quantum System. There may be NO
changes or mod icat ions to t he mech anics,
electronics , and/or sof tware of t he syste m.
DO NOT operate or store Quan tum comp onent s
•
outsi de of the speci ed environmen tal
limit s. A safety haza rd may occu r.
DO NOT use a mu ltiple s ocket ou tlet or ex tension
•
cord with a ny Quantum comp onent .
Degra datio n of sensors can re sult in inaccur ate
•
temperature rea dings a nd subs equent
outow temperatures. I f this oc curs, t he
Controller will indic ate a System Error.
™
PRESCRIBING INFORMATION (continued)
WARNINGS: (continued)
Use of acce ssori es, tr ansdu cers an d cables other than
•
those speci ed or provided by th e manuf acture r of this
equipment could result i n increased electrom agnet ic
emiss ions or d ecreased ele ctroma gneti c immun ity of
this eq uipme nt and res ult in improper o perat ion.
PRECAUTIONS:
Examine all sys tem com ponents for da mage, we ar,
•
and function ality p rior to u se. If any compon ent
appea rs fault y, damage d or defective, DO N OT USE.
Inspe ct all ca sings, component s and
•
enclos ures for da mage, cracks , breaks, or
loss of integrit y. If any of these are obs erved,
do not use a nd repl ace com ponent.
Exceeding rec ommended ow rates and /
•
or low ambi ent temperatu re may result
in lower out put temp eratu re.
Some dr ugs or dr ug preparatio ns may be sensitive
•
to warming. As with any ui d or bloo d warmi ng
system, carefu lly review th e drug manufac turers’
literature for info rmati on abou t therm al sensitivi ty.
Do not positio n the devi ce in a man ner tha t
•
makes it dicult to view or di sconn ect the
Controller and /or change the Batte ry.
When th e useful life of the lithium Batte ry
•
has bee n reached, it sh ould be dispos ed of
separ ately in accordance with na tiona l and
local co des. C ontac t your loc al enviro nment
control o r dispo sal agency for f urth er deta ils.
Used, single-use compone nts (TIS, T TS-B)
•
should b e disposed of in a ccorda nce with
local , national and /or international biohaz ard
protocols by the a ppropr iate personnel.
Porta ble RF communi catio ns equipment (including
•
peripheral s such as antenna c ables and external
antennas) shou ld be use d no closer than 30
cm (12 in ches) to any part of the Qua ntum Fluid
Warming Sys tem, in cluding cables spec ied by
the manufactu rer. Other wise, degradation of t he
performance of the equipme nt could re sult.
The Cont roller a nd Battery are not
•
intended for patient contact .
Although the Quantum has been tested to
•
insure it w ill sur vive a drop of 1 meter (3.28 ft),
care sho uld be ta ken that t he system is not
droppe d to reduce the pote ntial of damage.
It is recommend ed prop er Battery an d
•
Controller per formance be veri ed
before each use of th e Quantum.
Fully charg e new batteries u pon receipt and
•
prior to u se or sto rage to ex tend batter y life.
Check B atter y charge status p rior to e ach use to
•
ensure adequate charge fo r device o perat ion.
It is recommend ed that t he Battery be f ully
•
charge d before in itiating warming.
It is recommend ed that t he Battery
•
be charg ed afte r each us e.
The Battery Ch arger must be co nnected
•
to an ear thed mains socket outlet.
The Cont roller J acket should be replace d after every
•
10 uses (approximate) or six mo nths (whichever
occurs rst) o r at anytime the C ontrol ler Jacke t
appears damaged, loose-tting, or compromised.
LIFEWARMER
™
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INTENDED USERS &
LIFEWARMER
USE ENVIRONMENTS
Intended Users:
Opera tors of th e Quantum should be knowledgeable in th e use of IV administration set s for infu sion of uids an d
transfusio n of blood /bloo d produc ts. The Quantum the rmal tub ing set s (TIS and TTS-B) deliver IV soluti ons and
blood/blood p roduct s in a similar man ner as co nventional IV in fusio n and tra nsfusion sets.The Qu antum is d esigned for
quick set up and de ployme nt usin g minim al steps. Inten ded users include mil itar y medi cs, EMS P aramedics , regis tered
nurses, physicians and mid- level practitioners . Patie nt-users of the Quantum i nclude any adult p atient presenting with
the nee d for IV solution s, bloo d or bloo d produc ts who m ay bene t from war med ui ds..
Intended Use Environments:
The Qua ntum Blo od & Flui d Warming System is transporta ble. The intended use env ironments in clude hospit als (e.g .,
in-pat ient /full service s facil ities), clinical environmen ts (e.g., satellite emergenc y center s, outp atien t center s, etc.),
and eld e nvironments (e .g., po int of inj ury in cludi ng civilian an d battle eld locations) and tr ansport environme nts
such as emergen cy vehicles en rou te (i.e., xed and rotary wing aircraft a nd ground and ai r ambul ance). The Quan tum
Controller, Batte ry, TIS/TTS- B are inte nded for u se in the Patien t Environment. N ote: The B atter y Charg er shou ld only
be used i n hospi tal and protecte d xed structure environ ment s.
QUANTUM SYSTEM DESCRIPTION:
Device Description:
The Qua ntum Blo od & Flui d Warming System is a lightwe ight, b atter y powered, high ly port able, u id warm ing sys tem
in which t he warm ing ele ment is i ntegra ted with s peci ally designed i ntravascula r admin istra tion tubing. Fluid war ming
is achieved in the tubing t hrough t he use of p roprie tary therm oplastic po lyureth ane and a s oftw are control .alg orithm.
The Qua ntum IV ad minis trati on
tubing i s double-ex trude d to yield a
congu ratio n that ha s both an i nner
tubing l ayer and a n outer tu bing
layer. A conductive heating e lemen t
is betwe en the t wo layers b ut does
not come i n conta ct with the uid
path [Fi gure 1]. T he outer tubing layer
acts as a n insul ator while the in ner
tubing l ayer tra nsfers t he heat f rom
the heating ele ment to the uid path.
The Qua ntum Syste m, fully c harge d,
is able to wa rm and maintain up to
2 units ( 9 00mL +/- 100mL) of cold
(4ºC) bloo d produc ts or IV solutio ns to a pre-set temperatu re of 38ºC ± 2 ºC (100.4ºF ± 2) at a ow rate of 100 mL/min
(depen ding on t he ambient tem perature). Or, approximately 1700 mL of 20ºC IV solution to a set p oint of 38ºC +/- 2ºC
at a ow rate of 20 0 mL/min . Eective w armin g ow rates range fro m 2 to 200 mL /minute de pending on input uid
temperature and ambient conditions.
Thermistors located in the tub ing con tinually meas ure temp erature a nd provide that in put to the Controller. The
Controller ass esses the temp eratu re input a nd regul ates the amount of e nergy a pplied to the heating e lemen t needed
to reach an d maint ain a con stant uid temperatu re. The monitor ing and i ndependent appli catio n of energy (heat ) along
the uid path allows the Qu antum to respond to varyi ng temp erature input s from the uid sou rce to nea r the point of
patient entr y to ensure uid tem perature is ≥ 36ºC to < 44ºC at deliver y.
The Qua ntum is powered by a rechargea ble lit hium- polymer batte ry. The co mplete Q uantum B lood & Fluid Warmi ng
System, includi ng the B atter y, weighs less than 1 ,5 lbs. a nd can t ravel wit h the pat ient ac ross multiple cl inical use
environments w hile maintaining opt imum u id temp erature.
Binding layer securing
the heating element
In n er tub in g (cond uc t s
-8-
Outer tubing
Heating element
sterile uid pat h and
absorbs heat)
Figure 1:
Quantum Tubing
C
ross Section
™
QUANTUM SYSTEM COMPONENTS:
The Qua ntum Blo od & Flui d Warming System con sist s of sterile ther mal
IV tubin g (TT S-B or TIS), a Controller (i ncluding Jacket), Bat tery, and B atter y Charger..
LIFEWARMER
TUBING SETS:
Thermal Transfusion Set -Blood (TTS-B) | Thermal Infusion Set (TIS)
Intrava scula r admin istration sets for infusio n (TIS) o f IV uid s and tra nsfus ion (TTS- B) of bloo d/blo od products an d IV
uids . The set s are ass emble d and con sist of L ife Warmer’s proprietary the rmopl asti c tubin g with integrate d coppe rnickel heating elements, tempera ture sensing th ermis tors, a nd sta ndard IV a dmini strat ion com ponents (se e Figure s 2
and 3). The TIS and T TS-B connec t to the Controlle r via the c ircuit c artr idge co nnector. The TIS and TTS -B are prov ided
sterile, for sing le-pa tient u se only.
00 micron ltered
2
drip chamber
Circuit cartridge
connector
RED Roller
Clamps
“Y” t ype
dual spikes
Figure 2:
TTS-B Thermal
Transfusion Set -
BLOOD
M
ale Luer
Connector
R
ED Downstream
Roller Clamp
Clamps
Injection
lide
S
Ports
chamber
2
M
ale Luer
Connector
ip
Dr
0 gtt/ml
Figure 3:
Thermal Infusion
et - IV FLUIDS
S
Controller:
The Cont roller i s the com mand ce nter of th e Quant um System . It cont ains th e microprocessor
and cont rol algorithm that continually a sses ses temperatu re input from tubing thermistors and
regula tes the energy prov ided to t he tubing heating elements i n the proximal and/or distal
segme nts to rea ch and ma intai n tempe rature between 3 8ºC ± 2ºC / 100.4ºF ± 2) at patient
delivery. The Co ntrolle r receives power wh en conn ected to the Bat tery. The Controller is
reusab le. Sur face clean/disinfe ct only. (Co ntrolle r does not suppo rt/req uire ste riliza tion)..
B
LUE Rolle r Clamp
TIS
& Slid e clamps
Controller
cartridge
connector
njection
I
Ports
in jacket
Circuit
Controller Jacket:
The Cont roller c omes t ted with a Jacket th at perm its th e mating (conne ction) of the TIS o r
TTS- B tubin g circuit conne ctor to th e conne ctor slot on the Co ntrolle r. The Jacket must rem ain
in place for device operation. T he Jacke t also p rotect s the Controlle r and sho uld be rep laced
after approxim ately 10 uses or 6 months.
Cleaning Kit:
Kit cont ains hydrophob ic coating pack, extr a Contro ller Jacket, an d cleani ng brush for Jacket conne ctor slot.
™
B
attery C harger
Battery:
Suppl ies power to the Controller. Batter y is lith ium-
polymer and rech argea ble. Sur face clean/disinfe ct only.
(Batte ry doe s not sup port /req uire ste riliza tion).
Charger:
For charging the Q uantum Battery. AC-powere d reusa ble
component. S urfa ce clean /disinfect o nly. (Charge r does
not supp ort /require sterilization ).
Batter y
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