SERVICE
BULLETIN
PN: 21174579

RELEASE DATE:July 3, 2017

REVISION DATE(S): September 29, 2017 (Rev B), March 15, 2019 (Rev C), March 01, 2020 (Rev D),
December 05, 2022 (Rev E).
MODEL:

All LOX Portables and Reservoirs

ISSUE:

LOX label service kits

NOTES:CAIRE has created new symbolic labels for all LOX reservoirs andportable units. Prior to this change, CAIRE maintained a large variety of
LOX labels in stock due to the number of different languages throughout
our markets. The use of symbolic labels on LOX reservoirs and portables
will greatly reduce the number of labels that are currently required. InEurope, when replacing labelling on any CAIRE medical device, it is aregulatory requirement that the number of the notified body who
authorized the medical device at the time of manufacture not be modified.
In order to assist our European customers, CAIRE Inc. has created service
kits for each unit type. The service kits are specific to the appropriate CE
markings that are required for each unit.
The CE requirements are based on the model and the age of the device.
The European kits will include a symbolic warning label, a reference
guide for the symbols, and a replacement CE label. U.S. customers are
not required to maintain CE labeling on LOX reservoirs and portables.
Because of this, CAIRE has created separate U.S. label service kits that
only include the symbolic warning label and a reference guide for thesymbols.
The tables below detail the applicable service kits for reservoirs andportable units. European customers can determine the age of manufacture
by referencing each unit’s serial number. Diagrams are also provided
below that show the location where each label in the kit should be applied.

Ref 21174579 Rev E

Page 1 of 11

Non-CE Mark Kits (for the U.S.A and any country which does not require
CE marked products)
Model
Liberator
Stroller, Sprint, Spirit
H300 / PlusHELiOS Standard Reservoirs
HELiOS Universal Reservoirs
H850 / Marathon
C1000/C1000T
Companion Reservoirs

Label Service Kit Part Number
21194752
21194754
21194757
21194755
21194758
21194759
21194760
21194761

European Kits:
DateRange

Liberator

Prior2006

SN format
For Liberators manufactured before 2006, the serial
number was nine or ten numerical digits.

Range
All numerical only serialnumbers.
CBB3006XXXXXXCBB301618XXXX

CE0029Label Kit
Ref:21152753

2006 May 7,
2016

X=any value

CBB301619XXXXPresent
CE0459Label Kit
Ref:
21150538

X=any value
May 9,
2016 Present

Ref 21174579 Rev E

Page 2 of 11

Symbolic LabelTop Label (SOLDSEPARATELY)CE Label next tosymbolic label

Ref 21174579 Rev E

Page 3 of 11

Stroller /Sprint / HiFlow

DateRange

SN formatPrior2006

For Strollers and Sprints manufactured before 2006, theserial number was nine or ten numerical digits.

Range
All numerical only
serial numbers.
CBB3106XXXXXXCBB311618XXXX

CE0029

X=any value

Label Kit
Ref:21152754

2006 May 7,
2016

CBB311619XXXXPresent
CE0459Label Kit
Ref:
21150537

X=any value
May 9,
2016 Present

Top Label (SOLDSEPARATELY)

Symbolic LabelCE Label
when noUDI label

CE Label when UDIlabel fitted

Ref 21174579 Rev B

Ref 21174579 Rev E

Page 4 of 11

Spirit

Date
Range

SN formatPrior2006

For Spirits manufactured before 2006, the serial numberwas nine or ten numerical digits.

All numerical only
serial numbers.
CBB3706XXXXXXCBB371618XXXX

CE0029Label Kit
Ref:
21152754

Range

X=any value

2006 May 7,
2016

CBB371619XXXXPresent
CE0459Label Kit
Ref:21150537

X=any value

May 9,
2016 Present

Top Label(SOLD

Symbolic Label

CELabelwhen no

CE Label when
UDI label

Ref 21174579 Rev E

Page 5 of 11

Companion
Reservoirs

Date
Range

SN format

Range

CE0050Label Kit
Ref:
21150541

PriorMarch2010

For Companion Reservoir units manufactured before
March 2010, the serial number was five or eightnumerical digits.

All numerical onlyserial numbers.

CBB3010XXXXXXCBB301618XXXX
CE0029Label Kit
Ref:21152758

March2010 May 7,
2016

X=any value

CBB301619XXXXPresent
CE0459Label Kit
Ref:21152849

X=any value

May 9,
2016 Present

Symbolic Labels

CE Labelbelow

Ref 21174579 Rev E

Page 6 of 11

Helios
Standard
Reservoirs(H36/H46)

Date
Range

SN format

Range

PriorMarch2010

For Helios Standard Reservoir units manufactured
before March 2010, the serial number was five or eightnumerical digits.

All numerical only serialnumbers.

CE0050Label Kit
Ref:21150539

CBB3007XXXXXXCBB301618XXXX
CE0029Label Kit
Ref:
21152759

March2010 May 7,
2016

X=any value

CBB301619XXXXPresent
CE0459Label Kit
Ref:
21152755

Helios
UniversalReservoirs(U36/U46)

X=any value

May 9,
2016 Present

Date
Range

SN format

Range

CE0050Label Kit
Ref:
2115300
4PriorMarch2010

For Helios Universal Reservoir units manufactured
before March 2010, the serial number was five or eightnumerical digits.

All numerical only
serial numbers.

CBB3010XXXXXXCBB301618XXXX
CE0029Label Kit
Ref:
2115300
6March2010 May 7,
2016

Ref 21174579 Rev E

X=any value

Page 7 of 11

CBB301619XXXXPresent
CE0459Label Kit
Ref:
2115300
5May 9,2016 Present

X=any value

CE Label next tosymbolic label

Symbolic LabelRef 21174579 Rev E

Page 8 of 11

Companion
Portable(C1000/C1000T)
CE0050Label Kit Ref:
21150701

Date
Range

Prior
March2010

SN format

For Companion Portable units manufactured before
March 2010, the serial number was five or eightnumerical digits.

Range

All numerical only
serial numbers.
CBB3110XXXXXXCBB311618XXXX

CE0029Label Kit Ref:
21131485

March2010 May 7,
2016

X=any value

CBB311619XXXXPresent
CE0459Label Kit Ref:
21152747

X=any value

May 9,
2016 Present

Symbolic Labels

CE Label when UDIlabel fitted

CE Label
when noUDI label

Ref 21174579 Rev E

Page 8 of 11

Helios
H300/Plus
Portable

Date
Range

SN format

PriorMarch2010

For Helios H300/Plus Portable units manufactured before
March 2010, the serial number was five or eightnumerical digits.

Range

CE0050Label Kit
Ref:
21150540

All numerical only
serial numbers.

CBB3110XXXXXXCBB311618XXXX
CE0029March2010 May 7,
2016

Label Kit
Ref:21152761

X=any value

CBB311619XXXXPresent
CE0459Label Kit
Ref:
21152760

X=any value

May 9,
2016 Present

Helios
H850/Marathon
Portable
CE0050Label Kit Ref:
21153040

Date
Range

PriorMarch2010

SN format

For Helios H850/Marathon Portable units
manufactured before March 2010, the serial number
was five or eight numerical digits.

Range

All numerical only
serial numbers.
CBB3110XXXXXXCBB311618XXXX

CE0029Label Kit Ref:
21153041

Ref 21174579 Rev EMarch2010 May 7,
2016

X=any value

Page 9 of 11

CBB311619XXXXPresent
CE0459Label Kit Ref:
21153042

X=any valueMay 9,2016 Present

Symbolic LabelCE Label when UDIlabel fitted
CE Label
when no UDI
label

Should you have any issues with identifying the correct notified bodynumber for your device, please contact Customer or Technical Service
with the serial number of the device.

Ref 21174579 Rev E

Page 10 of 11

CONTACT:

For technical questions or concerns, contact Technical Service:USA:
800-482-2473
techservice.global@caireinc.com
Europe:+44 (0) 118 936 7060
techservice.global@caireinc.com
For ordering information or general inquires, contact Customer Service:USA:
800-482-2473
customerservice.usa@caireinc.com
Europe:+44 (0) 118 936 7060
customerservice.europe@caireinc.com

Copyright © 2022 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its products, orchange the prices, materials, equipment, quality, descriptions, specifications and/or
processes to its products at any time without prior notice and with no further obligation orconsequence. All rights not expressly stated herein are reserved by us, as applicable.

Ref 21174579 Rev E

Page 11 of 11