prismaLung Instructions for Use May 2013

Instructions for Use

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File Name: prismalung_instructions_for_use_may_2013.pdf

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English

English ... 3 Français ... 20 Deutsch ... 37 Italiano ... 54

Content 1. Definitions of Symbols Used on Labelling of Product ... 4 2. Product Description ... 5 2.1 The PrismaLung™ blood-gas exchanger ... 5 2.2 Extension Lines and Components ... 6 2.3 Accessories and Additional Required Equipment ... 6 3. Intended Use and Indications ... 7 3.1 Intended Use ... 7 3.2 Indications ... 7 3.3 Length of use ... 7 4. Contraindications, Complications and Interaction ... 7 4.1 Contraindications ... 7 4.2 Complications... 7 4.3 Interactions... 7 5. Cautions and Warnings ... 7 5.1 Cautions ... 7 5.2 Warnings ... 8 6. Performance Data ... 8 7. Storage ... 9 8. Warranty and Limitation of Liability ... 9 8.1 Contact ...10 ® 9. Preliminaries for the first use of PrismaLung™ blood-gas exchanger in Combination with Prismaflex HP-X disposable set ...10 ®

PrismaLung™ blood-gas exchanger in combination with Prismaflex CRRT set ...12 Instructions for Use ...12 Setup ...13 Priming ...14 Connect Patient and Start Treatment ...14 End treatment ...14 ® PrismaLung™ blood-gas exchanger in combination with Prismaflex HP-X set ...16 Instructions for Use ...16 Setup ...17 Priming ...18 End treatment ...19

For more information please contact: Novalung GmbH Im Zukunftspark 1 74076 Heilbronn Germany

Phone: +49 7131 2706-0 Fax: +49 7131 2706-299

[email protected] www.novalung.com

English

Note: These Instructions For Use are intended for all persons who use the PrismaLung™ blood-gas exchanger. Please read very carefully before use.

Definitions of Symbols Used on Labelling of Product Consult instructions for use

Do not reuse

Do not resterilize

Sterilized by ethylene oxide (EtO); followed by the sterilization date

Use by

Date of manufacture

Batch code

Catalogue number

Non-pyrogenic

Temperature limitation

Latex free

Do not use if package is damaged

Keep away from sunlight

Keep dry

Humidity limitation

Heparin coated

Made in Germany

English

Product Description

The PrismaLung™ kit is a disposable extracorporeal circuit for use with the Prismaflex® control unit equipped with software version 7.11 or later in combination with Prismaflex® disposable sets. The PrismaLung™ kit consists of the PrismaLung™ blood-gas exchanger and several extension lines and components. The PrismaLung™ kit is a sterile disposable product free of toxics and non-pyrogenic. The PrismaLung™ kit is sterilized by ethylene oxide (EtO).

2.1 The PrismaLung™ blood-gas exchanger The PrismaLung™ blood-gas exchanger integrates both a heat exchanger and a gas exchanger connected in series (see figure 1.) The PrismaLung™ blood-gas exchanger is equipped with preassembled tubing lines (see figure 2). These lines allow for connection to: blood lines of the Prismaflex® HP-X set, the extension lines (see section 2.2) when operating with Prismaflex® CRRT sets. The PrismaLung™ blood-gas exchanger is Rheoparin® coated. The heparin treated surface is created in the exchanger with approx. 17 IU (total amount). This coating provides improved blood compatibility of non-biological surfaces of the PrismaLung™ blood-gas exchanger. The gas exchanging part of the PrismaLung™ blood-gas exchanger is made of plasma tight hollow fibre membranes. The gas flow takes place through the inner lumen of the fibres. Blood is in contact with the outer side of the membranes, so that carbon dioxide is eliminated from the blood whereas some oxygen can diffuse into the venous blood. The heat exchanging part of the PrismaLung™ blood-gas exchanger is made of non-porous hollow fibre membranes. Temperature controlled water flows through the inner lumen of the non-porous hollow fibres, so that the temperature of the outside flowing blood is regulated. Figure 1: PrismaLung™ blood-gas exchanger flow paths

Figure 2: PrismaLung™ blood-gas exchanger ports 7 6

1 3

1 2 3 4

Blood inlet Blood outlet Gas inlet Gas outlet

5 6 7

Water inlet Water outlet Vent port

English

Table 1: PrismaLung™ blood-gas exchanger specifications Max. Blood flow ratenote Static priming volume Maximum gas flow rate Maximum blood side pressure Residual blood volume Gas exchanger Material Type Surface area Burst pressure of fibre Heat exchanger Material Type Surface area Burst pressure of fibre Performance factor Port configurations Blood in / Blood out Gas inlet, -outlet Water inlet, -outlet Vent port, venous

800 ml/min 65 ml 10 l/min 66,66 kPa/ 500mmHg 19 ml Polymethylpentene (PMP) plasma tight hollow fibres 0.32 m2 ≥ 200 kPa / ≥1500mmHg Polyester non-porous hollow fibres 0.074 m2 ≥ 600 kPa / ≥4500mmHg 0.63 Standard filter connector ISO 8637 compliant 1/4“; 1/4“ 1/4“ Hansen-type coupler Luer Lock female

Note: Actual maximum blood flow rate in use will be determined by the Prismaflex® operating range. Note: The following information is available upon request: a list of materials of the blood pathway; data related to blood cell damage; relevant tolerances for data presented.

2.2 Extension Lines and Components In addition to the PrismaLung™ blood-gas exchanger, the PrismaLung™ kit includes: - a gas line (green colour coded) used to connect the flowmeter to the gas inlet port [3] of the PrismaLung™ blood-gas exchanger, - a Christmas tree connector used to connect the gas line to a standard flowmeter connected to standard hospital-wall oxygen supply line - two colour coded extension lines to be used when combining the PrismaLung™ kit to Prismaflex® CRRT therapy Figure 3: Illustration of extension lines Inlet line

Outlet line

Table 2: Extension lines specifications Inlet line Connection to PrismaLung™ blood-gas exchanger Connection to Prismaflex® set

Outlet line

Female connector compliant to ISO 8638 Male Luer lock compliant to ISO 594/1 & 2

Female Luer lock compliant to ISO 594/1 & 2

Line length

60 cm

30 cm

Line volume

8 ml

4 ml

Line & connector material

PVC

2.3 Accessories and Additional Required Equipment Use of the PrismaLung™ kit in Prismaflex® system requires a specific holder to be mounted at the rear side of the Prismaflex® control unit; contact your local GAMBRO representative. Use of the PrismaLung™ heat exchanger requires a water supply from the NovaTherm® heater/cooler; contact your local GAMBRO representative.

English

Intended Use and Indications

3.1 Intended Use The PrismaLung™ kit is indicated for use only with the Prismaflex® control unit in providing extracorporeal gas exchange during Continuous Renal Replacement Therapy (CRRT) or Hemopurification (HP) therapy.

3.2 Indications The application of extracorporeal gas exchange (oxygenation and decarboxylation) and thermoregulation by use of the PrismaLung™ blood-gas exchanger is left to the discretion of the physician. In CRRT therapy, the PrismaLung™ kit can be used only in combination with Prismaflex® CRRT High Flow sets; refer to the Prismaflex® Operator’s Manual. In HP therapy, the PrismaLung™ kit can be used only in combination with the Prismaflex® HP-X set.

3.3 Length of use The PrismaLung™ blood-gas exchanger is intended for application up to 72 hours.

Contraindications, Complications and Interaction

Even if the product has been subject to risk analysis and the product was designed in accordance to current standard level of technology, a residual risk remains during clinical use. This is addressed by the following contraindications, complications cautions and warnings.

4.1 Contraindications The following contraindications are known: Do not use heparin coated blood-gas exchangers on patients with known heparin induced thrombocytopenia. Do not use heparin coated blood-gas exchangers on patients with known hypersensitivity to heparin or quaternary alkyl ammonium compounds. There are no other known contraindications when used as intended and within the specified operating conditions.

4.2 Complications The following complications can arise during use of the device: - Activating of inflammatory cascades due to contact of blood with artificial surfaces. - Hypothermia

4.3 Interactions The combination and compatibility of Medos products coated with Rheoparin® and other products which have a different coating has not been verified by Medos.

Cautions and Warnings

5.1

Cautions

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.

Read the Prismaflex® Operator’s Manual carefully prior to use. Read the IFU of the Prismaflex® HP-X set / the Prismaflex® CRRT set carefully prior to use. Dispose the product after use according to clinical and legal regulations. To prevent contamination the PrismaLung™ blood-gas exchanger must be used as soon as the packaging and caps are removed. Do not expose to heat or sun. The product should be stored in a cool, dry and dark place. Do not use solvents on the product such as alcohol, ether, acetone, liquid inhalation anaesthesia (e.g. halothan, enfluran, etc.). They can damage the products from the in- and outside. In order to avoid product damage, do not use lubricants, disinfectants etc. for tube connection. Tubes and Luer Lock connections have to be fixed and fastened by hand only. Other aids can damage the connectors. Due to sterilization procedure caps may loosen and have to be tightened again before application. All ports on the PrismaLung™ blood-gas exchanger others than used to connect the device to the HP-X set / CRRT set, the heater cooler and the gas line must not be removed or used during operation. The vented port only can be used for deaeration purpose. The PrismaLung™ blood-gas exchanger shall be connected to the Prismaflex® disposable set before the Prismaflex® automatic priming procedure is initiated. Follow instructions to ensure the whole blood circuit is completely primed and deaerated. The PrismaLung™ blood-gas exchanger shall be set on its dedicated holder on the right side of the Prismaflex® control unit. Do not use the Prismaflex® HP holder for the PrismaLung™ blood-gas exchanger. In CRRT therapy, the PrismaLung™ kit shall not be used in combination with the PrismaTherm II blood warmer, due to excessive extracorporeal blood volume and blood pressure drop. Only approved hypo-hyperthermia machines must be used for temperature regulation. Particular attention must be paid to extra corporeal blood volume with respect to patient size. Volume to be considered is the blood volume in the PrismaLung™ kit blood volume plus the blood volume of the Prismaflex® disposable set. (Refer to Specifications). Do not use hard tools to tap the gas exchanger during the priming procedure. Once the product has been primed it should be used within hours to minimise the danger of microbiological contamination and/ or precipitation in priming fluid. Do not remove the PrismaLung™ blood-gas exchanger from its holder after completion of priming. Flow meter must be used to control gas flow. Only non-humidified gas must be used for gas supply to the blood-gas exchanger. Flush the sweep line of PrismaLung™ blood-gas exchanger every 8 hours (increase to maximum gas flow for 1-5 sec.) to avoid accumulation of condensate and loss of gas exchange capabilities.

English

22. Appropriate anticoagulation must be used in order to minimize the risk of clotting. When using heparin for anticoagulation, the ACT (activated clotting time) must individually be set in a reasonable range (e.g. ACT 130 - 200 sec. or PTT 70-80) at all times. 23. The use of the blood-gas exchanger has to be continuously monitored. 24. The water pressure at the inlet of PrismaLung™ blood-gas exchanger must not exceed 750 mmHg (99 kPa) 25. Do not obstruct the gas-outlet of the PrismaLung™ blood-gas exchanger. 26. Water temperature at the inlet of the heat exchanger must not exceed 42°C.

5.2 1. 2. 3. 4. 5. 6. 7. 8. 9.

Warnings The use of operating procedures other than those published by the manufacturer or the use of accessory devices not recommended by the manufacturer can result in patient injury or death. Sterility is only guaranteed if the packaging is undamaged. Pay attention to the expiration date. The product must be carefully checked by the user before application for damages and intactness. For single use only. Do not resterilize. All products have to be used under aseptic conditions. Do not use the PrismaLung™ blood-gas exchanger on patients with known allergy to heparin or quaternary alkyl ammonium compounds. Do not attach/connect the PrismaLung™ blood-gas exchanger to the return line downstream of the air detector. The Prismaflex® system can not detect air introduced in the line downstream the air detector. This product must be used only for medical applications and should only be used under medical supervision and by suitably trained operators.

Performance Data

Inlet Conditions according to AAMI Standard (ISO 7199) by usage of bovine blood.

English

Storage

The product should be stored in a cool, dry and dark place. Storage temperature shall be kept between +5°C and +40°C. Humidity shall not exceed 80%.

Warranty and Limitation of Liability

The manufacturer warrants that this product conforms to the legal requirements, in particular those set forth in the Council Directive 93/42/EEC concerning medical devices. Therefore, should the product exhibit faults that can be directly attributed to material or processing errors that occurred during its manufacture or packaging (“faults”), and said faults occurred prior to the expiration date (UBD), the manufacturer will, at its discretion, replace the product • with one of identical design or • with one exhibiting the identical function. All the following conditions must be met in order to assert claims within the context of this warranty: • The product may not be used after the expiration date (UBD date). • The fault may not occur for the first time after the expiration date of the product. • If the product in question is a disposable product or is a product which the manufacturer designates as being for single use, the fault must be detected at the first use. • The fault must be reported immediately to the manufacturer or its representative. • The faulty product must be forwarded to the manufacturer or its representative immediately after the fault is reported. This warranty in no way limits and is valid in conjunction with the mandatory regulations governing warranties on the part of the seller and the product liability laws. In all other cases, this warranty applies only to the extent defined above. Additional claims arising from this warranty are excluded. This warranty as well as the cited legal claims applies in place of, and to the exclusion of, all other warranties, either verbal or written, express or implicit, issued by the manufacturer. None of our representatives or employees is empowered to conclude or agree undertakings to the contrary. Due to numerous factors such as shipping, storage, and handling on the part of the user, all of which lie outside the control of the manufacturer, Medos Medizintechnik AG is not liable in particular for damages of any type resulting directly or indirectly from the product or its use unless said damages can be proved to be the result of a product error.

English

In particular, the manufacturer assumes no liability for damages resulting from re-sterilisation or reuse of products approved for single use only, or which the manufacturer designates as being for single use.

Direct any complaints to GAMBRO.

8.1

Contact

Manufactured by Medos Medizintechnik AG Obere Steinfurt 8-10 52222 Stolberg GERMANY

Phone: +49 2402 9664 0 Fax: +49 2402 9664 60 www.medos-ag.com [email protected]

for: GAMBRO Lundia AB Box 1010 Magistratsvägen 16 SE-220 10 Lund SWEDEN

Phone: +46-46-16 90 00 Fax: +46-46-16 96 96 www.gambro.com

9. Preliminaries for the first use of PrismaLung™ blood-gas exchanger in Combination with Prismaflex® HP-X disposable set HP therapy must be enabled in Service mode. ®

PrismaLung™ blood-gas exchanger must be predefined in Custom Mode; see Prismaflex Operator’s Manual

English

& CRRT

Set-up Instructions for PrismaLung™ blood-gas exchanger in combination with Prismaflex® CRRT disposable set

English

PrismaLung™ blood-gas exchanger in combination with Prismaflex® CRRT set Instructions for Use Note: Below instructions complement the on-line instructions on the Prismaflex® control unit for the setup of the PrismaLung™ kit. Note: For more information about the ports of PrismaLung™ blood-gas exchanger please refer to chapter 2.1 Caution: The PrismaLung™ kit shall be connected to the Prismaflex® CRRT set before the Prismaflex® automatic priming procedure is initiated. Follow instructions to ensure the whole blood circuit is completely primed and deaerated. Caution: The PrismaLung™ kit shall not be used in combination with the PrismaTherm II blood warmer due to excessive extracorporeal blood volume and pressure drop in the blood circuit. Note: The use of PrismaLung™ kit causes pressure drop between filter outlet and deaeration chamber. This pressure drop is basically proportional to blood flow rate but also dependent on blood hemoconcentration at filter outlet. Therefore the utilization of PrismaLung™ kit biases to some extent Filter Pressure Drop and TMP measurements of the Prismaflex® system. The WARNING: Filter Extremely Positive alarm and the WARNING: Filter Clotted alarm may be triggered early when using the PrismaLung™ kit at high blood flow rate.

English

Setup 1. Start Prismaflex® control unit, choose prescribed CRRT therapy mode. 2. In Load Set screen, attach and load Prismaflex® CRRT disposable set according to Prismaflex® on-line instructions. 3. Press LOAD and follow on-line instructions.

4. In screen Prepare and Connect Solutions, install the PrismaLung™ blood-gas exchanger on its holder. PrismaLung™ blood-gas exchanger can be installed later, but must be installed before priming.

5. Take the extension lines out of their package. 6. Open the warmer connection (see picture) on the return line of the Prismaflex® set. Note: The warmer connection has been validated for use with the PrismaLung extension lines. Its use with the PrismaLung is equivalent to use with a Gambro approved blood warmer.

7. Connect the blue male Luer Lock connector of the red striped extension line to the female Luer-Lock connector on the CRRT set.

8. Connect the blue female Luer Lock connector of the blue striped extension line to the blue male Luer-Lock connector on the CRRT disposable set.

9. Connect the red and blue extension lines to the red and blue connections, respectively, on PrismaLung™ blood-gas exchanger.

10. Prepare and connect solution according to instructions on Prismaflex® screen. 11. Follow Prismaflex® on-line instructions till the Verify Setup screen.

English

Priming 12. To initiate the priming process in screen Verify Setup, press “PRIME + TEST” or “PRIME”. Monitor the priming process until time to turn the PrismaLung™ blood-gas exchanger. 13. When priming has started and 2 minutes remain, lift the PrismaLung™ blood-gas exchanger from its holder and hold it upside down for 20 to 30 seconds to remove air. Tilt if needed. Hold PrismaLung™ blood- gas exchanger below the deaeration chamber to maintain correct pressures in the system 14. Install the PrismaLung™ blood-gas exchanger back on its holder. 15. Wait for the completion of Prismaflex® priming and prime tests. 16. Inspect the PrismaLung™ blood-gas exchanger for air. If air still remains press MANUAL PRIME and lift the PrismaLung™ bloodgas exchanger from its holder, hold it upside down until all air is removed and put it back in its holder.

Forgot to install PrismaLung™ blood-gas exchanger? If prime and prime test is performed and PrismaLung™ blood-gas exchanger is not yet installed: - install PrismaLung™ blood-gas exchanger according to instructions 5-9. - press REPRIME and follow instructions 13-16.

Note: If manual prime is needed, check that the priming solution bag contains enough priming solution. If not connect a new priming solution bag. Note: Check the fluid level in the deaeration chamber and if necessary increase the level of the deaeration chamber as described on the screen Prime Test Passed. Caution: After Priming do not move PrismaLung™ blood-gas exchanger from its holder and avoid lifting of PrismaLung™ blood-gas exchanger to a higher level.

Connect Patient and Start Treatment 17. Connect patient and start treatment according to Prismaflex® online instructions. 18. When Prismaflex® blood circuit is stable remove the green cap on the PrismaLung™ blood-gas exchanger and connect the oxygen supply line (green line) to the PrismaLung™ blood-gas exchanger and the sweep gas inlet. The line-end holding the filter shall connect to the PrismaLung™ blood-gas exchanger. 19. Switch on the sweep gas flow and adjust the gas flow according to prescription. 20. If prescribed connect the NovaTherm® heater / cooler unit to the PrismaLung™ blood-gas exchanger; refer to the NovaTherm® IFU. Note: The warmer circuit must be connected in counter-current flow to the blood flow of the PrismaLung™ blood-gas exchanger (water in through lower port [5] / water out through upper port [6]).

End treatment 21. 22. 23. 24. 25.

Switch off the sweep gas flow. Stop the treatment. If prescribed and the set is not clotted, return the blood back to the patient. Disconnect the patient. Unload the CRRT set and discard the PrismaLung™ blood-gas exchanger with the set.

English

& HP-X

Set-up Instructions for PrismaLung™ blood-gas exchanger in combination with Prismaflex® HP-X set

English

PrismaLung™ blood-gas exchanger in combination with Prismaflex® HP-X set Instructions for Use Note: First use of PrismaLung™ blood-gas exchanger in combination with Prismaflex® HP-X disposable set requires the following: - HP therapy must be enabled in Service mode. - PrismaLung™ blood-gas exchanger must be predefined in Custom Mode; see Prismaflex® Operator’s Manual Caution: The PrismaLung™ blood-gas exchanger shall be set on its dedicated holder on the right side of the Prismaflex® control unit. Do not use the Prismaflex® HP holder with the PrismaLung™ blood-gas exchanger. Note: Below instructions complement and supersede the on-line instructions of Prismaflex® HemoPerfusion screens. I.e. the installation of PrismaLung™ blood-gas exchanger is done before priming begins. The instructions on Prismaflex® screens are developed for HP treatments. Even if the word “PrismaLung” blood-gas exchanger is stated on the screens some instructions might be incorrect or should be neglected. Note: The word HP-Cartridge on the Prismaflex® screens should be interpreted as “PrismaLung” blood-gas exchanger.

English

Setup 1. 2. 3. 4.

Start Prismaflex® control unit, choose HP therapy In Load Set screen, attach and load the Prismaflex® HP-X set according to Prismaflex® on-line instructions. Press LOAD. In screen Choose HP Cartridge, install the PrismaLung™ bloodgas exchanger on its holder. PrismaLung™ blood-gas exchanger can be installed later, but must be installed before priming.

Connect the red and blue connection lines (the ones with big caps) on the HP-X set to the red and blue connections, respectively, on PrismaLung™ blood-gas exchanger.

6. 7.

Select “PrismaLung” on the Choose HP Cartridge screen. Follow Prismaflex® on-line instructions till the Verify Setup screen.

English

Priming 8.

In Verify Setup screen, press “PRIME + TEST” or “PRIME” to initiate the priming sequence.

When the screen Priming, Access Line Complete is shown PrismaLung™ blood-gas exchanger is already installed, ignore instructions on Prismaflex® screen as they are not used for PrismaLung™ blood-gas exchanger. Just press CONTINUE.

Forgot to install PrismaLung™ blood-gas exchanger? 10.

install PrismaLung™ blood-gas exchanger according to instruction step 5. press CONTINUE and follow instruction step 10.

When the screen Verify HP Cartridge Setup is displayed, press CONTINUE to start the final priming cycle, and go straight ahead to next step 11. - The information in the screen must be ignored. - PrismaLung™ blood-gas exchanger shall be kept on its holder as shown on page 4.

11.

When priming has started and 2 minutes remain, lift the PrismaLung™ blood-gas exchanger from its holder and hold it upside down for 20 to 30 seconds to remove air. Tilt if needed. Hold PrismaLung™ blood- gas exchanger below the deaeration chamber to maintain correct pressures in the system.

12.

Place the PrismaLung™ blood-gas exchanger back on its holder.

13.

Wait for completion of Prismaflex® priming and prime tests.

14.

Inspect the PrismaLung™ blood-gas exchanger for air. If air still remains press MANUAL PRIME and remove the PrismaLung™ blood-gas exchanger from its holder, hold it upside down until all air is removed and put it back to its holder. Note: If manual prime is needed, check that the priming solution bag contains enough priming solution. If not connect a new priming solution bag. Note: Check the fluid level in the deaeration chamber and if necessary increase the level of the deaeration chamber as described on the screen Prime Test Passed. Caution: After Priming do not move PrismaLung™ blood-gas exchanger from its holder and avoid lifting of PrismaLung™ blood-gas exchanger to a higher level.

English

Connect Patient and start treatment 15.

Connect patient and start treatment according to Prismaflex® online instructions.

16.

When Prismaflex® blood circuit is stable remove the green cap on the PrismaLung™ blood-gas exchanger and connect the oxygen supply line (green line) to the PrismaLung™ blood-gas exchanger and the sweep gas inlet. The line-end holding the filter shall connect to the PrismaLung™ blood-gas exchanger.

17. Switch on the sweep gas flow and adjust the gas flow according to prescription. 18. If prescribed connect the NovaTherm® heater / cooler unit to the PrismaLung™ blood-gas exchanger; refer to NovaTherm® IFU. Note: The warmer circuit must be connected in counter-current flow to the blood flow of the PrismaLung™ blood-gas exchanger (water in through lower port [5] / water out through upper port [6]).].

End treatment 19. 20. 21. 22. 23.

Switch off the sweep gas flow. Stop the treatment. If prescribed and the set is not clotted, return the blood back to the patient Disconnect the patient. Unload the HP-X set and discard PrismaLung™ blood-gas exchanger with the set.

Français

et EERC

Instructions de configuration relatives à l’échangeur gazeux PrismaLung™ en association avec le set à usage unique

EERC Prismaflex®

Français

et HP-X

Instructions de configuration relatives à l’échangeur gazeux PrismaLung™ en association avec le set HP-X Prismaflex®

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prismaLung Instructions for Use May 2013