IFU Insert

Prismaflex ST Set
Emergency Use Authorization for the United States

The Prismaflex ST Set has been Authorized by the FDA to provide continuous renal replacement therapy
(CRRT) to treat patients in an acute care environment during the Coronavirus Disease 2019 (COVID-19)
pandemic.

The Prismaflex ST Set has neither been cleared or approved to provide CRRT in an acute care
environment.

The Prismaflex ST Set has been authorized by FDA under EUA200704.

The Prismaflex ST Set is Authorized only for the duration of the declaration that circumstances exist
justifying the authorization of the emergency use of the Prismaflex ST Set under section 564(b)(1) of the
Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Intended Use for Patients with COVID-19

The Prismaflex ST Set is indicated for use only with the Prismaflex control unit or with the PrisMax control
unit in providing continuous fluid management and renal replacement therapies in an acute care
environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The system is intended for
patients who have acute renal failure, fluid overload, or both.

Relative contraindications (individual risk/benefit to be determined by treating physician) for the use of
Prismaflex ST Sets include:
• The inability to establish vascular access
• Severe hemodynamic instability
• Known hypersensitivity to any component of the Prismaflex ST Set

This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.

All treatments administered with the Prismaflex ST Set must be prescribed by a physician. The size,
weight, metabolic and fluid balance, cardiac status, and general clinical condition of the patient must be
carefully evaluated by the prescribing physician before each treatment.

Additional Product Information for the United States

The tubing contained in the following product codes are labeled as DEHP-free in the IFU, this means that the
product was not made with DEHP plasticizer: 107643, 115308, 107636, 115309, 107640 and 115310.

The tubing contained in the following product codes were made using DEHP plasticizer: 955468 and
955596.

The following codes do not include reference to the PrisMax control unit; however, all Prismaflex ST Sets
may be used with the Prismaflex control unit or with the PrisMax control unit: 115308, 115309, 115310,
955468 and 955596.

To access COVID-19 Resources, product details, product use information, and the comprehensive
Prismaflex Control Unit Operator’s Manual and PrisMax Control Unit Operator’s Manual please visit the
Baxter Healthcare Acute Therapies website at http://www.renalacute.com
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ST60 SET / ST100 SET / ST150 SET

Instructions for use

사용 지침

115308
115309
115310 Date of Revision: 2019-12-01

Made in France
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Blood warmer connection (blue)

혈액가온기 연결부(파란색)

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English....................................................5
한국어.....................................................9
Installation guide..................................16

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DEFINITION OF SYMBOLS
ENGLISH 한국어

TITLE AND
SYMBOL GRAPHIC
NUMBER OF 기호 설명
& REF NUM / 기호 그래픽 SYMBOL TITLE SYMBOL DESCRIPTION (EXPLANATORY TEXT) 기호 이름
STANDARD / 이름및 (설명문)
및 참조 번호
표준 번호

5.1.1 Indicates the medical device manufacturer, i.e. the natural or

현재 이름으로 시중에 출시되기 전 장치의 설계, 제조, 포장,
Manufacturer legal person with responsibility for the design, manufacture,
ISO 15223-11 제조사 라벨 표기 등에 책임이 있는 자연인 또는 법인을 가리키는 의료
packaging and labelling of a device before it is placed on the
장치 제조사를 나타냅니다
market under his own name.

5.1.3
Indicates the date when the medical device was manufactured.
ISO 15223-11 Date of manufacture Format should 제조일자 의료 장치를 제조한 날짜입니다. YYYY-MM-DD의 형식입니다.
be YYYY-MM-DD.

5.1.4 Indicates the date after which the medical device is not to be
이 날짜 이후에 의료 장치를 사용해서는 안 됩니다.
ISO 15223-11 Use-by date used. Format should 사용기한
YYYY-MM-DD의 형식입니다
be YYYY-MM-DD

5.1.5
Indicates the manufacturer’s batch code. Synonyms are “lot 제조사의 배치 코드입니다. “로트 번호”, “배치 번호”와 같은
ISO 15223-11 Batch code 배치 코드
number” and “batch number” 말입니다.

5.1.6 Indicates the manufacturer’s catalog number. Synonyms are 제조사의 카탈로그 번호입니다.“참조 번호”, “재주문 번호”와
ISO 15223-11 Catalogue number 카탈로그 번호
“reference number” and “reorder number” 같은 말입니다.

Indicates the presence of a sterile fluid path within the medical

5.2.3
device in cases where other parts of the medical device, 의료 장치의 외부를 비롯한 다른 부분은 무균 상태가 아닐 수도
ISO 15223-11 Sterile fluid path including the exterior, might not be supplied sterile. The 무균 수액 경로 있지만 장치 내에 무균 수액 경로가 존재한다는 의미입니다.
method of sterilization shall be indicated in the empty box, as 살균 방법을 빈 상자에 적절하게 명시해야 합니다.
appropriate.

5.2.8
Do not use if package is Indicates a medical device that should not be used if the 포장이 손상되었거나 열려 있는 경우 사용하면 안 되는 의료
ISO 15223-11 포장 손상 시 사용 금지
damaged package has been damaged or opened. 기기를 뜻합니다

5.3.1
Indicates a medical device that can be broken or damaged if not 주의해서 다루지 않으면 깨지거나 손상될 수 있는 의료 기기를
ISO 15223-11 Fragile, handle with care 깨지기 쉬우므로 주의 요함
handled carefully. 뜻합니다.

5.3.4 Indicates a medical device that needs to be protected from

Keep dry 건조한 곳에 보관 습기로부터 보호해야 하는 의료 장치라는 의미입니다.
moisture.
ISO 15223-11 OR 또는 또는
OR
Keep away from rain 비 맞지 않도록 주의 비를 맞지 않도록 주의해야 하는 의료 장치라는 의미입니다.
Indicates a medical device that needs to be kept away from rain.

5.3.7
Indicates the temperature limits to which the medical device can
ISO 15223-11 Temperature Limit 온도 제한 의료 장치를 노출해도 안전한 온도 제한입니다.
be safely exposed.

5.4.2
Indicates a medical device that is intended for one use, or for 한 번만 사용해야 하거나 환자 한 명의 단일 처치에 사용해야
ISO 15223-11 Do not re-use use on a single patient during a single procedure. Synonyms for 재사용 금지 하는 의료 장치를 나타냅니다. “재사용 금지”는 “일회용” 및 “한
“Do no re-use” are “single use” and “use only once”. 번만 사용”과 같은 말입니다

5.4.4 Indicates the need for the user to consult the instructions for
다양한 이유로 의료 장치 자체에 명기되지 않은 경고 및 지침과
use for important cautionary information such as warnings and
ISO 15223-11 Caution 주의 같은 중요한 주의 정보에 대하여 사용자가 사용 지침을 숙지해야
precautions that cannot, for a variety of reasons, be presented
함을 나타냅니다.
on the medical device itself.

NA, European countries only /

To indicate the manufacturer of the product contributes to the 해당 제품의 제조업체가 회수 및 재활용 비용을 부담함을
NA, pays européens seulement Green Dot Symbol 그린 도트 기호
cost of recovery and recycling 나타냅니다
/ NA, sólo países europeos

0623
ISO 70002 This way up Indicates the correct, upright position of the package 이 쪽을 위로 포장을 올바르게 세우는 방향을 나타냅니다

5.4.3
Indicates the need for the user to consult the instructions for use.
한다는 의미입니다. “사용 지침 참고”는 “조작 지침 참고”와
ISO 15223-11 Consult instructions for use Synonym for “Consult instructions for use” is “Consult operating 사용 지침 참고
같은 말입니다.
instructions”.

1
ISO 15223-1:2016 Medical Devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General Requirements / 의료 장치 - 의료 장치 라벨, 라벨링 및 정보에 사용하는 기호는 파트 1:
2
ISO 7000 Graphical symbols for use on equipment - Registered symbols / 장비에 사용되는 그래픽 기호 - 등록 기호

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ENGLISH

The PRISMAFLEX ST60/ST100/ST150 Set is manufactured by GAMBRO This set is intended for use in the following veno-venous therapies : SCUF ; CVVH ;
Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCE. CVVHD ; CVVHDF.
All treatments administered via the PRISMAFLEX Set must be prescribed by a
Caution: Federal law (USA) restricts this device to sale by or on the order physician. The size, weight, state of uremia, cardiac status, and general physical
of a physician. condition of the patient must be carefully evaluated by the prescribing physician
before each treatment.

DEFINITION OF EXPRESSIONS USED

CONTRAINDICATIONS
IN THIS MANUAL

In this document : There are no known contraindications to continuous renal replacement therapies.

“Warning” is used to alert the user/operator not to take a certain action which,
if taken, can cause a potential hazard and result in a serious adverse reaction, injury
or death. CAUTIONS AND WARNINGS
“Caution” is used to alert the user/operator to take a certain action to protect
against a potential hazard, which, if ignored, could have an adverse effect on the
patient or on the device. Note : additional warnings and cautions pertaining to the PRISMAFLEX system
“Note” is used as a reminder to the user/operator on normal treatment activity and are included in the PRISMAFLEX control unit operator’s manual.
on what is a suitable action in a particular situation.

SCUF: Slow Continuous UltraFiltration.

Cautions
CVVH: Continuous Veno-Venous Hemofiltration. It is recommended that particular attention must be paid with respect to extra-
CVVHD: Continuous Veno-Venous HemoDialysis. corporal blood volume (see General Characteristics).
CVVHDF: Continuous Veno-Venous HemoDiaFiltration.
The PRISMAFLEX ST60 Set should be restricted to patients with a body weight
Predilution: addition of replacement fluid to the blood stream upstream to the filter.
greater than 11kg (24lb). Refer to PRISMAFLEX operator’s manual for any
Postdilution: addition of replacement fluid to the blood stream downstream to
additional weight restrictions that might apply.
the filter.
The PRISMAFLEX ST100 Set and ST150 Set should be restricted to patients with
a body weight greater than 30kg (66lb).

PRODUCT DESCRIPTION 1.  arefully read these instructions for use and the PRISMAFLEX control unit
C
operator’s manual before using this product.
2.  tore the PRISMAFLEX Set in a dry place, between 0° C (32° F) and 30° C (86° F).
S
 he PRISMAFLEX ST60 / ST100 / ST150 Set is a disposable, extracorporeal
• T
3. S
 ome solvents and other chemicals, if used in contact with the filter, could damage
circuit for use with the PRISMAFLEX System.
the set. No chemical of this type should be used without permission of the
 he PRISMAFLEX ST60 / ST100 / ST150 Set consists of a AN69 ST hollow fiber
• T manufacturer. The following are especially forbidden :
hemofilter/dialyzer* and tubing lines. a) halogenated aromatic and aliphatic solvents,
• T
 his filter is permanently connected to a blood access line (red-striped), a blood b) ketonic solvents.
return line (blue-striped), a dialysate inlet line (green-striped) and an effluent outlet 4.  o prevent contamination, this PRISMAFLEX Set must be used as soon as its
T
line (yellow-striped). packaging and sterilization caps are removed.
• T
 he other lines of the set include : 5. D
 o not use this set if the packaging is damaged, if the sterilization caps are
- a replacement solution line (purple-striped) missing or loose, or if any of the lines in the set are kinked.
- a pre blood pump line (white striped)
- an anticoagulant line (syringe) 6. Do not try to remove the filter from the cartridge plate.
he configuration of the PRISMAFLEX set allows the following uses
• T 7. D
 estroy this set after single use, using aseptic technique for potentially
depending on the configuration of the automated clamps on the machine : contaminated equipment. Do not resterilize. The PRISMAFLEX ST is intended
- purple circuit : replacement in pre or post dilution (CVVH and CVVHDF), for single use only. Re-using the PRISMAFLEX ST may cause serious
- green circuit : damage to the product resulting in patient injury or death.
* dialysate in CVVHD and CVVHDF, 8. U
 se aseptic techniques when handling all blood and fluid lines in the set.
* replacement in post dilution in CVVH. 9a. U
 se only prescribed dialysate and replacement solutions with the PRISMAFLEX
• T
 he pre blood pump line allows the addition of infusion solution close to the end System. These solutions must have a density similar to that of saline solutions
of the patient access line and before the blood pump. This can be used as an (close to 1) in order to avoid errors in the volumes used for fluid exchange.
additional pre-dilution infusion to the replacement circuit. 9b. In CVVHD and CVVHDF modes, it is recommended to use only sterile bagged
 he PRISMAFLEX Set is provided with a specific small volume deaeration
• T dialysate.
chamber in which blood does not appear to mix with the replacement liquid the 9c. In CVVH modes and CVVHDF, if a commercially available replacement solution
majority of the time; this is a normal operation of the device. is used, it must be labeled as intended for intravenous injection.
• A
 5-liter bag is provided to be connected to the end of the blood return line to 10. C
 onnect the PRISMAFLEX Set to a patient via venous blood access and return
initially collect priming solution, during priming. Then, during treatment, this bag is devices. A double-lumen venous catheter is the recommended blood access
used to collect ultrafiltrate and/or used dialysate (connection at effluent line). Other device; however, two single-lumen venous catheters can also be used. There
sterile 5 and 9 liter bags and sterile, non pyrogenic spikes can be ordered separately. are 3 possible accesses for PRISMAFLEX system therapies : subclavian,
• A
 ll line connectors are compatible with the ISO 594/1 & 2 international standards jugular or femoral vein.
concerning conical fittings. 11. 
 uring priming and operation, observe closely for leakage at joints and
D
 he fluid pathways of the PRISMAFLEX Set are guaranteed sterile and non
• T connections within the set, notably the bags. Leakage can cause blood loss or
pyrogenic. air embolism. If leakage cannot be stopped by tightening the connections,
 he PRISMAFLEX ST60 / ST100 / ST150 Set is sterilized by ethylene oxide
• T replace the set.
(EtO). Deaeration is such that EtO residuals comply with the ones described 12. B  efore connecting the blood return line to the patient, check for absence of
in ISO 10993-7. air between the segment of line inserted in the air detector and the patient-
• E
 xpiration date : please refer to product label. end of the return line.
If air is present in this part of the return line, connect the access line to the
* In this document the hemofilter/dialyzer will be referred to as “filter”.
patient and start the blood pump while leaving the return line connected to
the collection bag. Purge the air present in the end-part of the return line,
then stop the blood pump. Disconnect the return line from the collection bag,
and connect it to the patient.
INTENDED USE / INDICATIONS If the amount of air in the blood circuit is too large, reprime the circuit completely
before patient connection.
13. After priming is complete, do not remove the pressure pods from the
The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control pressure sensor housings. If pods are removed, the set must be changed or the
Unit in providing continuous fluid management and renal replacement therapies. Diaphragm Reposition procedure performed (refer to PRISMAFLEX control
The system is intended for patients who have acute renal failure, fluid overload, unit operator’s manual).
or both.

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14. If the patient is not immediately connected to the PRISMAFLEX Set after priming 6. T
o assure adequate filter performance, it is recommended that the set be
is complete, flush the set with at least 1 000 mL priming solution [saline or changed every 24 hours of use. However, the set must be changed after 3 days
alkaline solution (pH ≥ 7.3) with heparin added] prior to connecting the patient. (72 hours) and/or the maximum process volume of blood (780 L) whichever
This requires use of a new bag of priming solution. occurs first. Continued use beyond these limits (either 72 hours or 780 L) could
15.  Use a 21-gauge or smaller needle to obtain blood/fluid samples or remove result in rupture of the pump segments, with risk of patient injury or death.
trapped air from the PRISMAFLEX Set. Use of larger needles can cause
holes in the sample sites, resulting in blood loss or air embolism.
16. T
 he PRISMAFLEX control unit may not be able to detect disconnections of
the set from the patient’s catheter. Carefully observe the set and all operations SPECIFICATIONS
while using the PRISMAFLEX System for a patient treatment.
17. D
 ue to the nature of use of the PRISMAFLEX Set (low blood flow rates,
extended treatment time, and other special factors), the possibility See Tables at end of document.
for coagulation within the blood flowpath is substantially enhanced.
Give careful attention to the possible medical hazards associated with SET MATERIALS
coagulation of the blood flowpath and comply with the minimum blood flow
AN69 ST hollow fiber : Acrylonitrile and sodium methallyl sulfonate copolymer
rates specifications of each filter (see the “Filter Operating Specifications”
+ Polyethylene Imine (surface treatment agent)
section).
Housing and headers : Polycarbonate
18. O
 nce priming is complete the Set’s blood circuit will still contain heparinised
saline solution. Depending on the level of the patient’s bleeding risk Potting compound : Polyurethane
the physician must decide if an additional priming using 500 mL non Tubing material : Plasticized polyvinyl chloride (PVC)
heparinised saline solution is necessary. Cartridge : PETG
19. F
 ilter performance specifications require a minimum blood flow rate, specific
to each filter, to avoid risk of hemoconcentration (see “Filter Operating Note : the following information is available from the manufacturer upon request :
Specifications” section). • information about test methods used to obtain performance characteristics,
20. D

 uring use, closely monitor the patient’s clotting parameters, especially • the number and range of particles in the effluent from the dialyzer prepared as
when increasing the amount of anticoagulant delivered or after changing the recommended for clinical use,
anticoagulant syringe. • the types and amounts of residue from the sterilization process.

21. O
 nly use the syringes listed in the operator’s manual. The use of non-
recommended syringes can be a hazard for the patient. Particularly if there is The PRISMAFLEX Set is not made with rubber natural latex.
no Luer-lock on the syringe, the seal between the syringe and the heparin line
can no longer be guaranteed.
22. When not using the pre blood pump infusion circuit, it is recommended to
clamp this circuit close to its connection to the access line; this will prevent
INSTRUCTIONS FOR USE
the sedimentation of blood into the pre blood infusion line.
23. A
 lways inspect the blood flowpath for signs of clotting before returning the Note : use the set by following the detailed on-line instructions provided by the
blood in the set to the patient. If clotting is suspected, do not return the PRISMAFLEX control unit. Additional information is available in the PRISMAFLEX
blood to the patient. control unit operator’s manual.
24. In case of re-circulation mode, the set must be replaced if the maximum
re-circulation time is exceeded; refer to the PRISMAFLEX operator’s manual Note : a TMP > 40 kPa (300 mmHg) does not allow a higher ultrafiltration.
for more information.
Perform the following procedures when the appropriate instructions appear on the
In case of poor blood return, the set must be replaced.
display of the PRISMAFLEX control unit.
In all cases, it is essential to reprime the set with fresh saline immediately
before patient connection.
25. T
 he PRISMAFLEX set offers a specific design of the deaeration chamber Load Set
which aims to trap air before blood is returned to the patient.
26. T
 he PRISMAFLEX Set is not designed for a heater to be connected to the 1. R
 emove the set from the packaging support. Holding the filter vertically (so that
replacement solution line. A heater generates air bubbles which collect in the the label is the right way up), carefully snap the set cartridge into the cartridge
return deaeration chamber. Therefore, it is recommended not to use a heater carrier (center of front panel).
on the replacement solution line. 2. A
 ttach the 3 pressure pods to their proper pressure housings. Press effluent line
27. T he PRISMAFLEX set is not designed for a heater to be connected to the into blood leak detector; snap discharger ring into its guide.
dialysate solution line. A heater generates air bubbles which collect in the 3. Temporarily hang access/effluent Y line on priming hook.
filtrate/dialysate compartment of the filter and decrease diffusive performance 4. P
 lace deaeration chamber in its holder; attach chamber monitor line to return
of the device. Therefore it is recommended not to use a heater on the pressure port.
dialysate solution line.
5. Insert return line into air detector and return line clamp.
In general terms, introduction of air in the dialysate circuit should be
minimised throughout the course of the treatment, especially when replacing 6. Connect return line to effluent bag.
dialysate solution bags. 7. Open effluent scale; hang collection/effluent bag. Close scale.
28 H
 ypothermia must be monitored in all CRRT treatments, and special attention
should be paid when increasing exchange volumes above 2 L/h ; it may be Prepare and Connect Solutions
necessary to warm the patient because of hypothermia.
29. T
 he deaeration chamber line (blue-striped) is equipped with 1. H ang bag of priming solution [saline or alkaline solution (pH ≥ 7.3) with added
a Luer-lock connection near the deaeration chamber. 5000IU Unfractionated heparin/liter] (correctly homogenised) on priming hook
This connector is intended to join the extension line of a blood warmer. Refer (left corner hook top of front panel). Connect access (red)/effluent (yellow) Y-line
to the specific Instructions for Use and strictly follow detailed instructions for to priming solution bag.
set up of this line. Do not use this connection for any other purpose. 2. If required, connect PBP line (white) to pre blood pump (PBP) bag; hang bag
on its scale.
30. D
 o not attach/connect the extension line of a blood heater to the return line
downstream of the air detector. The PRISMAFLEX system cannot detect air 3. Hang replacement solution (CVVH, CVVHDF) on purple scale hook. Connect
introduced in the line downstream of the air detector. replacement solution line (purple) to replacement solution bag.
4. In CVVHD/CVVHDF hang dialysate on green scale hook. Connect dialysate line
(green). In CVVH hang replacement solution on green scale hook (postdilution
Warnings replacement). Connect green striped line to bag.
1. T
 he use of operating procedures other than those published by the manufacturer Note : see Caution no. 10 a, b, c.
or the use of accessory devices not recommended by the manufacturer can 5. C onnect anticoagulant line to filled anticoagulant syringe. Install syringe in pump
result in patient injury or death. (see Help).
2. U
 se only PRISMAFLEX Sets with the PRISMAFLEX control unit. The use of 6. Unclamp any clamped lines. Verify all connections are secure. Press PRIME
non-PRISMAFLEX Sets can result in patient injury or death. to start automatic priming.
3. S
 hould acute allergic reactions (first-use syndrome) occur in patients receiving
treatment via the PRISMAFLEX ST60 / ST100 / ST150 Set, immediately stop
the treatment and administer appropriate intervention. Pay special attention to
patients receiving ACE inhibitors and/or having already shown similar allergic
reactions (see “Hypersensitivity Reactions” section).
4. D
 o not allow air to enter the blood compartment of the filter after priming is started.
If a large amount of air enters, the set must be replaced.
5. S
 ince drugs can pass through the membrane of the filter, the dosage of
associated drug treatments must be adjusted for patients on continuous renal
replacement therapy.

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Prime Set A. With Blood Return

Note : see Cautions no. 12 through 15, cautions no. 27, 28 and 31, and Warning no. 4. Note : see Caution no. 24.

Priming includes multiple self-tests and takes approximately 10 minutes. After the Note : a sterile spike connector may be required.
cycle is complete :
1. T
 urn off the power. Clamp the access line (red-striped) and disconnect from the
1. E xamine set carefully to be certain all connections are secure, all lines are
patient. Attach the access line to a 1-liter bag of sterile saline (use spike connector
unobstructed, and there are no leaks in the tubing.
if needed). Unclamp the access line.
2. L eave priming solution and prime collection bags attached until ready to connect
patient. 2. P
 ress the return clamp button (left side of the return line clamp assembly) and
hold in the “in” position. With the other hand, remove the return line (blue-striped)
3. Continue chosen treatment by following the instructions on the display of the from the return line clamp.
PRISMAFLEX control unit.
3. V
 isually check the fluid level in the deaeration chamber. If the level is insufficient:
The PRISMAFLEX Set must be carefully deaerated. - disconnect the deaeration chamber service line from the return pressure port on
the PRISMAFLEX machine (the level will automatically rise in the deaeration
chamber),
- reconnect the line once the correct fluid level is reached.
Anticoagulation Considerations
4. R
 emove the pump crank from its holder on the rear panel. Insert crank into the
Note : see Cautions no. 18 through 22 and Warning no. 6. rotor of the blood pump and turn clockwise until sufficient blood is returned
to the patient.
Note : in order to gain full benefit from the AN69ST in terms of improvement of
hemocompatibility, it is recommended to add 5000IU of unfractionated heparin Warning : the alarm system is disabled. Visually check for air in the blood
per liter of priming/rinsing solution. This procedure allows the adsorbtion of return line until the patient is disconnected.
active heparin onto the AN69ST before the start of extrracorporeal circulation.
Consequently, the systemic anticoagulation strategy during treatment will be 5. C
 lamp the return line (blue-striped) and disconnect from the patient. Clamp
adapted with respect to patient specificity. In the cases where priming/rinsing lines to all bags.
without addition of unfractionated heparin, we recommend infusing the loading 6. P
 ress the two clips of the cartridge carrier to release the cartridge. Starting
dose of heparin to the patient 2 to 5 minutes before connection to the filter. with the peristaltic pump, insert the pump crank into the rotor and turn each
pump counterclockwise.
Initiate anticoagulation of the blood flowpath, as prescribed by the physician. During
use, monitor the patient’s clotting parameters; adjust the anticoagulation settings on 7. W
 hen the pump segments are free, grasp the cartridge and pull out to disengage
the PRISMAFLEX control unit, according to the physician’s prescription. Notably it is the lines from the pinch valves. Take the set off the control unit and discard
possible to infuse a loading dose of anticoagulant immediately after patient connection. as usual.
Anticoagulation plays an important part in extending filter life by retarding plugging
Note : remaining solutions may be used with a new set, if desired.
and clotting.
Warning : ensure patient is disconnected from set before removing set from
control unit.
Change Set Procedure
To remove this set, load a new set and continue with present treatment : B. Without Blood Return
Press “STOP” from the Status screen, then press “CHANGE SET” and follow the
on-line instructions. Note : the patient will lose the blood contained in the blood flowpath during a
manual termination without blood return.
Note : operator can return blood to the patient prior to disconnecting, if desired
(see Caution no. 24). 1. T
 urn off the power. Clamp the access line (red-striped) and return line (blue-
striped) and disconnect from the patient.
2. Clamp lines to all bags.
Re-circulation procedure 3. P
 ress the two clips of the cartridge carrier to release the cartridge. Starting
with the blood pump, insert the pump crank into the rotor and turn each pump
To set-up the re-circulation of the circuit:
counterclockwise.
Press “STOP” on the status screen; then press “RECIRC” and follow the on-line
4. W
 hen the pump segments are free, grasp the cartridge and pull out to disengage
instructions.
the lines from the pinch valves. Take the set off the control unit and discard
Note : the operator must return blood present in the set to the patient, then as usual.
disconnect the patient and circulate a sterile saline solution in the blood circuit of
the set. Once the treatment can be re-started, the set must be re-primed and re-
rinsed with a sterile saline solution before reconnecting the patient (see cautions
n° 24 and 25).
SPECIAL PROCEDURES IN CASE
OF COMPLICATION
End Treatment Procedure
To end the present treatment and remove this set  : Filter Membrane Blood Leaks
Press “STOP” from the Status screen, then press “END TREATMENT” and follow
the on-line instructions. Blood leaks through the filter membrane are automatically detected by the PRISMAFLEX
Control Unit alarm system. A warning alarm is generated and blood loss is limited
Note : operator can return blood to the patient prior to disconnecting, if desired by immediate stoppage of all pumps.
(see Caution no. 24).
To return blood to the patient, press STOP from the alarm screen, then press
CHANGE SET from the Stop screen and follow the on-line instructions.

External Blood Leaks

MANUAL TERMINATION Note : see Cautions no. 16, 17 and 22.

External blood leakage may not be immediately identified by monitoring equipment

Manual termination may be necessary due to power loss or an alarm of the and could result in significant blood loss. Check the filter and all connections of the
PRISMAFLEX control unit. The alarm screen tells the operator if a manual disposable tubings during treatment to minimize the risk of leakage. If an external
termination is required. blood leakage is observed, immediately stop the blood pump. Initiate corrective
action by securing connections or replacing the PRISMAFLEX Set.
Note : the following instructions are also found in “Troubleshooting” in the
PRISMAFLEX control unit operator’s manual. If necessary, administer adequate replacement solution to the patient to compensate
for blood loss.

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Hypersensitivity Reactions
Note : See Warning no. 3.

Should acute allergic reactions (first use syndrome) occur within the first few
minutes of the treatment, it is important to react immediately by discontinuing the
session and administering appropriate treatment.
Patients receiving angiotensin converting enzyme (ACE) inhibitors as medication
can develop, within the first few minutes of a treatment, symptoms similar to
acute allergic reactions i.e bronchospasm, edema of airways or larynx, dyspnea,
angioedema, urticaria, nausea, vomiting, diarrhea, respiratory arrest, abdominal
cramping, hypotension, hypovolemic shock and death.
However, for these patients, administration of antihistamines often does not alleviate
the symptoms. In this case, treatment must be stopped and a more aggressive first-
line therapy for an anaphylactoid reaction should be initiated immediately after the
onset of symptoms.
Therefore, special attention ought to be paid to patients receiving ACE inhibitors
and/or having already shown similar reactions.

WARRANTY AND LIMITATION OF LIABILITY

a) T
 he manufacturer warrants that the PRISMAFLEX Set has been manufactured in
accordance with its specifications and in compliance with good manufacturing
practices, other applicable industry standards and regulatory requirements.
If provided with the lot/serial number of the defective product, the manufacturer
will, by replacement or credit, remedy manufacturing defects in the PRISMAFLEX
Set becoming apparent before the expiration date.

b) T
 he warranty under paragraph a) above is in lieu of, and to the exclusion of,
any other warranty, whether written or oral, express or implied, statutory or
otherwise, and there are no warranties of merchantability or other warranties,
which extend beyond those described in paragraph a) above. The remedy
set out above for manufacturing defects is the sole remedy available to any
person due to defects in the PRISMAFLEX Set and the manufacturer shall not
be liable for any consequential or incidental loss, damage, injury or expense
arising directly or indirectly from the use of the PRISMAFLEX Set, whether as
a result of any defect therein or otherwise.

c) T
 he manufacturer shall not be liable for any misuse, improper handling, non-
compliance with warnings and instructions, damage arising from events after the
manufacturer’s release of the PRISMAFLEX Set, failure or omission to inspect
the PRISMAFLEX Set before use in order to ensure that the PRISMAFLEX
Set is in proper condition, or any warranty given by independent distributors
or dealers.

d) T
 he manufacturer is GAMBRO Industries, 7 avenue Lionel Terray, BP 126,
69883 MEYZIEU CEDEX, FRANCE.

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GENERAL DATA / 일반 데이터 PRISMAFLEX FILTER OPERATING SPECIFICATIONS

필터 작동 사양 PRISMAFLEX
ST60 SET ST100 SET ST150 SET ST60 SET ST100 SET ST150 SET
Weight / 무게 795 g 830 g 905 g Maximum TMP* / 최대 TMP* 450 mmHg
60 kPa
Overall dimensions / 전체 크기
Maximum blood pressure / 최대 혈압 500 mmHg
lenght / 길이 27 cm 27 cm 27 cm 66,6 kPa
width / 너비 22 cm 22 cm 22 cm
height / 높이 9 cm 9 cm 9 cm Minimum blood flow rate / 최소 혈류량 50 mL/min 75 mL/min 100 mL/min

Blood volume in set / 세트의 혈액량 (± 10%) 93 mL 152 mL 189 mL Maximum blood flow rate / 최대 혈압 180 mL/min 400 mL/min 450 mL/min

PRISMAFLEX PRISMAFLEX PRISMAFLEX

ST60 SET ST100 SET ST150 SET

QB/QS** = 100 mL/min QB/QS** = 150 mL/min QB/QS** = 200 mL/min

QUF*** = 0 mL/min QUF*** = 0 mL/min QUF*** = 0 mL/min

QD****** (L/h) 1 2.5 4 1 2.5 4 8 1 2.5 4 8

(mL/min) 17 42 67 17 42 67 133 17 42 67 133

Urea /  요소
(± 10%) 17 40 56 17 41 63 97 17 42 66 117
Vit B12 / 비타민 B12 15 26 30 16 32 41 50 17 38 51 68
(± 20%)
Inulin / 이눌린 (± 20%) 13 19 22 15 26 30 35 16 33 40 49

CVVHD CLEARANCES (Continuous veno-venous hemodialysis) Clearances versus inlet dialysate flow rate (37°C)
CVVHD 제거율 (지속적 정정맥 혈액 투석) 유입 투석액 유속(37°C)에 대한 제거율

* Transmembrane pressure / 막투과압

** Arterial blood flow rate / 동맥 혈류량
*** Ultrafiltration flow rate (on PRISMAFLEX system, the ultrafiltration flow rate = fluid removal flow rate + replacement flow rate + pre blood pump flow rate) /
초여과 유속(PRISMAFLEX 시스템에서 초여과 유속 = 수분 제거율 + 대체용액 유속)
**** Hematocrit / 헤마토크릿
***** Protein concentration / 단백질 농도
****** Dialysate flow rate / 투석액 유속

PRISMAFLEX PRISMAFLEX PRISMAFLEX

FILTER DATA 필터 데이터 ST60 SET ST100 SET ST150 SET

NOMINAL PHYSICAL CHARACTERISTICS 공칭 물리적 특성

Effective surface area 유효 표면적 0.6 m2 1 m2 1.5 m2
Fiber internal diameter (wet) 섬유 내부 직경 240 µm
Fiber wall thickness 섬유 벽 두께 50 µm

IN VITRO PERFORMANCES ≠ 시험관 내 성능 ≠

44 mL ± 10 % 69 mL ± 10 % 105 mL ± 10 %
Blood priming volume 혈액 프라이밍 용량

Blood pressure drop (post dilution) 혈압 강하 (후희석)

(bovine blood, Htc****32%, Cp***** 60 g/L, 37°C) (소 혈액, Htc****32%, Cp***** 60g/L, 37°C) ± 20 % ± 20 % ± 20 %
QB** = 100 mL/min, QUF*** = 1 L/h QB** = 100 mL/min, QUF*** = 1 L/h 46 mmHg 31 mmHg 20 mmHg
QB** = 180 mL/min, QUF*** = 2 L/h QB** = 180 mL/min, QUF*** = 2 L/h 84 mmHg 55 mmHg –
QB** = 300 mL/min, QUF*** = 2 L/h QB** = 300 mL/min, QUF*** = 2 L/h 79 mmHg 51 mmHg
QB** = 400 mL/min, QUF*** = 2 L/h QB** = 400 mL/min, QUF*** = 2 L/h 100 mmHg 64 mmHg

Sieving coefficient
(bovine plasma, Cp 60 g/L, 37°C) (소 혈장, Cp 60 g/L, 37° C)
QB/QS** = 100 mL/min, QUF*** = 20 mL/min QB/QS** = 100 mL/min, QUF*** = 20 mL/min
- Urea 1
- Vitamin B12 1
- Inulin 0.96
- Myoglobin 0.58
- Albumin < 0.01

≠ T
 ypical mean values obtained from laboratory testing of post-sterilization sample lots. Results may vary depending on patient and clinical conditions. / 
멸균 이후의 샘플 로트에 대한 실험실 테스트를 통해 확인한 일반적인 평균값입니다. 결과는 환자 및 임상적 조건에 따라 달라질 수 있습니다.

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“In vitro” ultrafiltration with blood (values ± 20 %).

(Bovine blood at 37°C, Hct 32 %, Protein concentration 60 g/L).
Ultrafiltration is controlled by the PRISMAFLEX System and is independent of the ultrafiltration coefficicent (KUF).
"시험관 내" 혈액 초여과(값 20%).
(소 혈액, 37°C, Hct 32%, 단백질 농도 60g/L).
초여과는 PRISMAFLEX 시스템에서 제어되며 초여과 계수(KUF)의 영향을 받지 않습니다.

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Prismatherm

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MONITOR
INSTALL SET DIRECTLY ONTO

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Patented ready to use PrismaFlex set packaging.

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Baxter, AN69, Prismaflex and Prismatherm are trademarks of Baxter International Inc. or its subsidiaries.