Cell Saver Elite Operation Manual Rev AC Jan 2012

Printed in France © 2011, 2012, Haemonetics Corporation. All rights reserved.

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CONSUMER INFORMATION Proprietary rights

The contents of this manual are the property of the Haemonetics Corporation. Haemonetics®, Cell Saver®, Elite® and SmartSuction® are trademarks or registered trademarks of the Haemonetics Corporation in the United States and/or other countries. Any information or descriptions contained in this manual may not be reproduced and released to any of the general public, or used in conjunction with any professional instruction without written consent of Haemonetics Corporation, USA. Please direct any written inquiries to the appropriate address. International headquarters Haemonetics S.A. Signy Centre Rue des Fléchères 6 P.O. Box 262 1274 Signy Centre, Switzerland Tel.: +41 22 363 9011 Fax: +41 22 363 9054

Disclaimer

Corporate headquarters Haemonetics Corporation 400 Wood Road Braintree, MA 02184 U.S.A. Tel.: +1 781 848 7100 Fax: +1 781 848 5106

This manual is intended as a guide to provide the operator with necessary instructions on the proper use and maintenance of certain Haemonetics Corporation products. This manual should be used in conjunction with instruction and training supplied by qualified Haemonetics personnel. Any failure to following the instructions as described could result in impaired product function, injury to the operator or others, or void applicable product warranties. Haemonetics accepts no responsibility for liability resulting from improper use or maintenance of its products. Utilization of Haemonetics products may require the operator to handle and dispose of blood-contaminated material. An operator must fully understand and implement all regulations governing the safe handling of blood products and waste, including the policies and procedures of their facility. Handling and use of any blood products collected using Haemonetics equipment are subject to the decisions of the attending physician or other qualified medical personnel. Haemonetics makes no warranty with respect to such blood products.

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Haemonetics worldwide

Haemonetics (Hong Kong) Ltd. Rooms 2202, 22/F Harbour Centre, 25 Harbour Road Wanchai, Hong Kong Tel.: +852 2868 9218 Fax: +852 2801 4380

Haemonetics Austria Handelsges.m.b.H. Mariahilfer Strasse 123 3rd floor 1060 Wien, Austria Tel.: 0800 29 2777 Fax: 0800 29 2820 Haemonetics Belgium-NV Braine-L’Alleud Parc de L’Alliance 9 Boulevard de France, bât A 1420 Braine L’Alleud Belgium Tel.: (FR): 0800 754 80 Fax: 0800 75512 Tel. (NL): 0800 754 82 Fax: 0800 755 12 Haemonetics BV Claudius Prinsenhof Verlengde Poolseweg 34-46 4818 CL Breda The Netherlands Tel.: 0800 0222 707 Fax: 0800 0223 066 Haemonetics CZ, spol. s.r.o. Ptašínského 8 60200 Brno, Czech Republic Tel.: 800 143 243 Fax: 800 143 250 Haemonetics France SARL 46 bis, rue Pierre Curie Z.I. Les Gâtines 78370, Plaisir, France Tel.: 0800 90 11 58 Fax: 0800 91 48 76 Haemonetics GmbH Wolfratshauser Straße 84 81379 Munich, Germany Tel.: 0800 180 8890 Fax: 0800 182 8064

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Haemonetics Hospitaler LTDA Avenida Bernardino de Campos, 98 Sobreloja, Paraisio, CEP 04004-040 City of São Paulo State of São Paulo, Brazil India Representative Office Haemonetics (Hong Kong) Ltd. JMD Regent Square Regus - Level 6 Mehrauli Gurgaon Road Gurgaon - 122 001 Haryana (Delhi-NCR) India Tel.: +91 124 471 1819 Fax: +91 981 027 3237 Haemonetics Italia SA Via Senigalia 18/2 - Torre A Milan 20161 Italy Tel.: 800 870 200 Fax: 800 870 375 Haemonetics Japan GK Kyodo Building, 16 Ichiban-cho, Chiyoda-ku Tokyo 102-0082, Japan Tel.: +81 3 3237 7260 Fax: +81 3 3237 7330 Haemonetics Korea, Inc. 30th Floor ASEM Tower 159-1 Samsung-dong, Kangnam-ku Seoul 135-798, Korea Tel.: +82 2 6001 3280 Fax: +82 2 6001 3281

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Haemonetics Medical Devices (Shanghai) International Trading Company Room 1103-06 Evergo Mansion No. 1325 Middle Huaihai Road 200031 Shanghai, China Tel.: +86 21 3406 0700 Fax: +86 21 5466 8852 Haemonetics Scandinavia AB Ideon 223 70 Lund, Sweden Tel.: 020 797 150 Fax.: 020 794 670 Haemonetics Asia Incorporated Taiwan Branch 26F-1, No. 102, Roosevelt Road Sec. 2 Taipei, Taiwan Tel.: +886 2 2369 0722 Fax: +886 2 2364 3698

Haemonetics® Cell Saver® Elite® Operation Manual

United Kingdom Sales Office Haemonetics Ltd. Suite 1/Building 5 5 Hercules Way Leavesden Park Watford WD25 7GS United Kingdom Tel.: 0808 234 4817 Fax: 0808 234 4845 Lebanon Representative Office Haemonetics SA c/o The Regus Group Azarieh Bldg., Block 3, 5th floor Regus, Beirut, Lebanon PO Box 11-503 Russia Representative Office Haemonetics SA Smolenskaya Passage Smolenskaya Square 3 121099 Moscow Russia Tel.: +7 495 937 8239

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Table of contents Chapter 1, Introduction THE HAEMONETICS CELL SAVER ELITE DEVICE... 1-2 What is the purpose of this manual?... 1-2 What is the Cell Saver Elite Autotransfusion System?... 1-2 Indications for use... 1-2 Contraindications... 1-3 New features of the Cell Saver Elite system... 1-3 Blood product quality... 1-4 SYMBOLS... 1-5 Symbols found in this document... 1-5 Symbols found on the device... 1-5 DEVICE SPECIFICATIONS... 1-8 Device classification... 1-8 Physical specifications... 1-8 Environmental specifications... 1-8 Electrical specifications... 1-9 Suction specifications... 1-10 Laser specifications... 1-10 ORDERING INFORMATION... 1-12

Chapter 2, Equipment description OVERVIEW... 2-2 TOP DECK AND FRONT PANEL COMPONENTS... 2-3 Device cover... 2-3 Effluent line sensor... 2-3 Air detector... 2-3 Pump... 2-3 Handle... 2-3 Valve module... 2-4 Centrifuge system... 2-5 REAR AND SIDE PANEL COMPONENTS... 2-7 Waste bag weigher... 2-7 Air intake... 2-7 Air exhaust filter... 2-7 Touch screen storage mount... 2-7 Vacuum connection... 2-8 Touch screen cable entry... 2-8 Equipotential ground terminal connection... 2-8 Reservoir weigher connection... 2-8 Power entry module... 2-8 Power cord... 2-8

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Table of contents

TOUCH SCREEN... 2-9 Status beacon... 2-9 Barcode reader... 2-9 STOP key... 2-10 Touch screen mount... 2-10 USB connection... 2-10 Graphical user interface... 2-10 CART COMPONENTS... 2-21 IV poles... 2-21 Device mount... 2-21 Wheels... 2-22 Reservoir weigher... 2-22 Saline hangers... 2-22 Handle... 2-22 Processing set tub holder... 2-22 Step plate... 2-22 Removable bins... 2-22

Chapter 3, Disposable set description OVERVIEW... 3-2 PROCESSING SET ELEMENTS... 3-3 Tubing harness... 3-3 Bags... 3-4 Centrifuge bowl... 3-4 RESERVOIR... 3-6 THE A&A LINE & POST-OP SET... 3-7 A&A line... 3-7 Post-op set... 3-7 VACUUM LINE... 3-8 SEQUESTRATION SET... 3-9

Chapter 4, Safety and patient care precautions STORING AND HANDLING THE DEVICE AND DISPOSABLES... 4-2 Storing and handling the device... 4-2 Storing and handling the disposables... 4-2 Inspecting the material... 4-2 Transporting the device... 4-3 WARNINGS FOR THE OPERATOR... 4-5 Electrical shock hazards... 4-5 Leakage current control... 4-5 Power outlet connection... 4-5 Laser radiation hazards... 4-5 Mechanical hazards/rotating parts... 4-6 Communicable disease precautions... 4-6 PREVENTING PROBLEMS DURING A PROCEDURE... 4-7 Understanding the risk of hemolysis... 4-7

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Avoiding flow restrictions... 4-7 Avoiding overheating... 4-8 Avoiding continuous aspiration... 4-8 Avoiding red blood cell spillage... 4-9 Managing the inventory of air... 4-10 PATIENT CARE PRECAUTIONS... 4-11 Reinfusing blood... 4-11 Replacing depleted clotting factors... 4-11 Contraindications for use... 4-12 Using anticoagulants... 4-12 FACTORS AFFECTING PROCESSING TIME... 4-13 Cell Salvage... 4-13 Sequestration... 4-13

Chapter 5, General operation: Cell Salvage PREPARING THE CELL SAVER ELITE DEVICE... 5-2 Connecting to power... 5-2 Positioning the device... 5-2 Unfolding the biohazard waste bag... 5-3 Powering on procedure... 5-4 INSTALLING THE CELL SALVAGE DISPOSABLES... 5-6 Inspecting the disposable sets... 5-6 Installing the reservoir and A&A line... 5-6 Setting up the processing set installation... 5-8 Installing the RBC bag... 5-8 Installing the tubing harness... 5-9 Installing the bowl... 5-9 Installing the effluent line sensor tubing... 5-10 Hanging the waste bag... 5-11 Connecting the reservoir... 5-11 Setting up the saline solution... 5-12 Inspecting the installation... 5-12 Initiating a procedure... 5-13 PERFORMING THE INTRAOPERATIVE CELL SALVAGE PROCEDURE . . . 5-14 Procedure overview... 5-14 Additional functions... 5-15 Processing a partial bowl... 5-16 Monitoring the waste bag... 5-16 Reinfusing processed blood... 5-17 Changing processing sets during a procedure... 5-18 Changing the bowl size during a procedure... 5-18 COMPLETING A PROCEDURE... 5-19 Additional functions... 5-20 PERFORMING THE POSTOPERATIVE CELL SALVAGE PROCEDURE... 5-22 Installing the postoperative disposable set... 5-22 Setting the suction level... 5-23 Transporting the device... 5-23

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Table of contents

Chapter 6, General operation: Sequestration SETTING UP A SEQUESTRATION PROCEDURE... 6-2 Procedure overview... 6-2 Setting up the device... 6-2 Selecting the Sequestration protocol... 6-2 Protocol settings... 6-4 INSTALLING THE DISPOSABLE SET... 6-5 Installing the processing set... 6-5 Installing the blood bag adaptor harness... 6-5 Installing the collection bag harness... 6-6 Inspecting the installation... 6-6 Initiating a procedure... 6-7 PERFORMING A SEQUESTRATION PROCEDURE... 6-8 Processing from blood bags... 6-8 Filling the bowl... 6-8 Collecting PPP... 6-9 Collecting PRP... 6-10 Emptying the bowl... 6-10 Concentration during Sequestration... 6-11 Completing the Sequestration cycle... 6-11 Ending the Sequestration protocol early... 6-12 Changing to a Cell Salvage procedure... 6-12 Transferring the RBCs for reinfusion... 6-13 Removing the plasma product... 6-13 Removing the Sequestration and processing sets... 6-14

Chapter 7, Protocol settings OVERVIEW... 7-2 Understanding settings groups... 7-2 Protocol Settings screen... 7-3 Working with settings groups... 7-3 MODIFIABLE SETTINGS... 7-6 Default settings... 7-6 Cell Salvage settings... 7-7 Parameters... 7-9

Chapter 8, Procedure records OVERVIEW... 8-2 CONSUMABLE RECORDS... 8-3 Editing consumable records... 8-3 Deleting consumable records... 8-4 Adding consumable records... 8-5 PROCEDURE RECORDS... 8-6 Entering/editing procedure information... 8-8 DEVICE RECORDS... 8-9 VIEW/EXPORT RECORDS... 8-10

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Viewing records... 8-10 Exporting records... 8-11

Chapter 9, Help system OVERVIEW... 9-2 THE HELP SYSTEM... 9-3 Accessing the help system... 9-3 Navigating help topics... 9-4 Disposable loading demo... 9-4 Performing a search... 9-5 EVENT MESSAGE HELP... 9-7

Chapter 10, Cleaning and maintenance CLEANING AND MAINTENANCE... 10-2 Cleaning/maintenance schedule... 10-2 Cleaning supplies... 10-2 Cleaning the device... 10-3 Replacing the biohazard waste bag... 10-5 Cleaning the optical lenses... 10-5 Cleaning the centrifuge well... 10-6 Cleaning the fluid detector... 10-6 Cleaning the pump... 10-6 Washing/replacing the air filters... 10-6 Replacing the fuses... 10-7 CUSTOMER SERVICE... 10-9 Services... 10-9

Chapter 11, Troubleshooting TROUBLESHOOTING SCENARIOS... 11-2 Vacuum problems... 11-2 Decreased air flow / aspiration problems... 11-2 Touch screen problems... 11-3 Device cover problems... 11-3 EVENT MESSAGES... 11-4

Chapter 12, Reference information APPENDIX A: COMPLICATIONS AND CONTRAINDICATIONS... 12-2 References... 12-6 APPENDIX B: IEC 60601-1-2:2001 STANDARD REQUIREMENTS... 12-7 Operation precautions... 12-7 Essential performance... 12-7 Electromagnetic compatibility... 12-8 APPENDIX C: SYSTEM PERFORMANCE... 12-12 Cell Salvage... 12-12 APPENDIX D: ASSEMBLING THE CART... 12-13

Haemonetics® Cell Saver® Elite® Operation Manual

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Chapter 1

Introduction THE HAEMONETICS CELL SAVER ELITE DEVICE... 1-2 What is the purpose of this manual?... 1-2 What is the Cell Saver Elite Autotransfusion System?... 1-2 Indications for use... 1-2 Contraindications... 1-3 New features of the Cell Saver Elite system... 1-3 Blood product quality... 1-4 SYMBOLS... 1-5 Symbols found in this document... 1-5 Symbols found on the device... 1-5 DEVICE SPECIFICATIONS... 1-8 Device classification... 1-8 Physical specifications... 1-8 Environmental specifications... 1-8 Electrical specifications... 1-9 Suction specifications... 1-10 Laser specifications... 1-10 ORDERING INFORMATION... 1-12

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Introduction

THE HAEMONETICS CELL SAVER ELITE DEVICE What is the purpose of this manual?

The Cell Saver® Elite® Autotransfusion System Operation Manual provides operators with the information needed to safely operate and maintain the Cell Saver Elite device and ensure optimal performance. The manual includes: 

Detailed descriptions of the device and all components



How to safely operate the device and troubleshoot any difficulties



How to properly handle and maintain the device

Use this manual in conjunction with training supplied by qualified Haemonetics® personnel. This manual covers device list numbers CSE-E-XX and CSE-EA-1000. (-XX refers to the regionalization code for the shipping destination of the device.)

What is the Cell Saver Elite Autotransfusion System?

The Cell Saver Elite Autotransfusion System provides intraoperative and postoperative blood salvage for surgical procedures with medium to high blood loss. The shed blood is collected in a reservoir, processed in a centrifuge bowl to pack red blood cells (RBCs), and then washed to remove cell stroma, platelets, activated clotting factors, extracellular potassium, free hemoglobin, anticoagulant, and cardioplegia. The washed, packed RBCs are then pumped to a bag for gravity reinfusion to the patient, or, to the arterial line of an extracorporeal circuit for reinfusion to the patient. Prior to autotransfusion, the device can also sequester platelets using the autotransfusion disposable in conjunction with a Sequestration set. The Cell Saver Elite system consists of the following three parts:

Indications for use



Cell Saver Elite device: the electro-mechanical device and graphical user interface (GUI) touch screen.



Disposables: the single-use collection material including reservoir, aspiration and anticoagulant (A&A) line, processing set, and vacuum line.



Solutions: anticoagulant and wash solutions for collecting and processing salvaged blood.

The Haemonetics® Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of

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the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

Contraindications

The risk/benefit ratio of blood salvage must be determined on an individual basis by the surgeons, anesthesiologists, and transfusion medicine specialists involved in the patient’s care. Refer to Appendix A for a chart of contraindicated substances, the effects of their use, and the recommended corrective actions to perform. The use of reinfused blood from the Cell Saver Elite system may be contraindicated, for example, in the case of sepsis or malignancy. The responsibility for the use of this device belongs solely to the physician in charge. Warning: The Cell Saver Elite device is not intended to be used for pleural or mediastinal drainage.

New features of the Cell Saver Elite system

The Cell Saver Elite system introduces key enhancements to the Cell Saver line of products that increase device capabilities and ease of use. These new enhancements include: 

Three suction options: on-board SmartSuction® technology, regulated onboard suction, and post-op suction.



The ability to retain data for up to 100 procedures and continue a procedure after being powered down during transport from the operating room to the post-anesthesia care unit (PACU).



A built-in barcode reader to record disposable set, solutions, and operator/ patient information.



The ability to download data using a USB flash drive.



A touch-screen display that provides both a simple interface during operation and allows operators to easily access advanced configuration options.

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Blood product quality

Introduction

RBC product for transfusion processed by the Cell Saver Elite system meets the following criteria: Table 1-1, RBC product criteria Bowl type

Hct

Free Hgb washout

RBC recovery

125 & 225 mL Latham bowls

> 40%

> 95%

> 90%

125 & 225 mL partially full Latham bowl

N/A

> 95%

N/A

125 & 225 mL Latham bowl Emergency mode

> 40%

> 95%

N/A

70 mL blow molded bowl

> 40%

> 95%

> 90%

Caution: Actual performance results may vary depending on many in-use variables.

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SYMBOLS Symbols found in this document

The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator. Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Caution: advises the operator against initiating an action or creating a situation which could result in damage to equipment or impair the quality of the blood products; personal injury is unlikely. Warning: advises the operator against initiating an action or creating a situation which could result in serious personal injury to the patient or operator. The following bullet types are used in this manual to indicate lists and actions for the operator:

Symbols found on the device



Text preceded by this bullet indicates an item on a list of information for the operator.



Text preceded by this bullet indicates an action for the operator.

The following symbols may appear on the device or device packaging. Attention Consult accompanying documents.

Type CF Type CF applied part provides a specific degree of protection against electric shock, particularly regarding allowable leakage current and reliability of the protective earth connection. Electrical and electronic equipment waste (applies to EU only) Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and electronic equipment). IPX1

Protection against ingress of vertically dripping water Indicates that the enclosure of the device is designed to be dripproof, providing a higher than ordinary level of protection from drips, leaks and spills.

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Introduction

Manufacturer

Alternating current

Fuse

Equipotentiality Identifies the terminals which, when connected together, bring the various parts of a system to the same potential.

EC REP

Authorized representative in the European Community

Rx only (applies to USA only) Federal (USA) Law restricts the device to sale to or on the order of a physician. Serial number

REF

Catalog number

ETL

Laser radiation

Shock hazard

General symbol for recovery/recyclable To indicate that a material is part of a recovery/recycling process. Note: Applicable only to those products or materials for which, at the end of life, there is a well-defined collection route and recycling process, and which does not significantly impair the effectiveness of other recycling schemes.

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250 mmHg

Maximum vacuum

Pollution control mark Pollution control mark for products containing any of the six referenced substances (Lead, Mercury, Cadmium, etc...) according to Chinese regulations. Storage conditions, humidity level

Storage conditions, temperature level

Storage conditions, keep dry

Fragile, handle with care

This end up

Read the instruction manual

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Introduction

DEVICE SPECIFICATIONS Device classification

The Cell Saver Elite is classified as a continuous operation, Class I, Type CF, IPX1 device, as defined by IEC 60601 standards for medical electrical equipment.

Physical specifications

The approximate dimensions and weight of the Cell Saver Elite device are as follows: Depth/cm (in.)

Height/cm (in.)

Width/cm (in.)

54.6 cm (21.5 in)

41.9 cm (16.5 in)

29.8 cm (11.75 in)

IV poles extended

67.3 cm (26.5 in)

182.9 cm (72 in)

53.3 cm (21 in)

IV poles down

67.3 cm (26.5 in)

121.9 cm (48 in)

53.3 cm (21 in)

Weight of device

25 kg (56 lbs)

Weight of cart

18 kg (39 lbs)

Device alone Device with cart

The noise level of the Cell Saver Elite device is < 70 dB.

Environmental specifications

The following environmental conditions should be respected pertaining to operation and storage of the Cell Saver Elite device: Conditions

Values

Ambient operating temperature

10 °C to 27 °C (50 °F to 80.6 °F)

Storage/transportation temperature

-20 °C to 50 °C (-4 °F to 122 °F)

Operating humidity level

8 to 80% R.H., non-condensing above 0 °C

Atmospheric pressure range

< 2438 meters (8000 ft.)

Note: Store disposables in a dry place away from solvent vapors and extremes of temperature. Warning: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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Introduction

Electrical specifications

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The electrical specifications for operating the Cell Saver Elite device are as follows: Electrical input power Rated voltage

Rated current

Fuse

Frequency

100–120 V

3.0 A

T3.15A250V

50/60 Hz

200–240 V

1.5 A

T3.15A250V

50/60 Hz

Enclosure/chassis leakage current specifications* Condition Normal

Single fault

Polarity

Ground

Max value

Normal

Normal

100 µΑ

Reverse

Normal

100 µΑ

Reverse

Open

500 µΑ

Normal

Open

500 µΑ

*In accordance with IEC/EN60601-1standard, medical electrical equipment, general requirements for safety.

Note: The power source used must be properly grounded.

Caution: The Cell Saver Elite device must be operated in an environment compatible to the requirements of the IEC 60601-1-2:2001 Standard, Electromagnetic compatibility (EMC). Additional IEC compliance information is available in Chapter 12.

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Suction specifications

Introduction

The specifications for the Cell Saver Elite suction are as follows: Characteristics

Values

SmartSuction® Recommended reservoir volume

≤3L

Recommended A&A line length

≤ 12 ft [3.6 m]

Recommended A&A line inner diameter

0.3 in [7.6 mm]

Recommended suction tip inner diameter

0.3 in [7.6 mm]

Operating vacuum

20 to 150 mmHg (2.7 to 20.0 kPa; 26.7 to 200 mbar)

Vacuum cutoff

175 mmHg (23.3 kPa; 233 mbar)

Maximum free air flow

40 L/min

Manual suction Operating vacuum

50 to 250 mmHg (6.7 to 33.3 kPa; 66.7 to 333.3 mbar)

Maximum free air flow

40 L/min

Post-op suction

Laser specifications

Operating vacuum

25-100 mmHg (3.3 to 13.3x kPa; 33.3 to 133.3 mbar)

Maximum free air flow

40 L/min

The Cell Saver Elite device is a class 3R laser product. The laser specifications for the Cell Saver Elite device are as follows: Laser specifications Max radiation output

3 mW

Wavelength

650 nm

Max light output

7 mW (bowl optics) 1.7 mW +/- 0.2 mW (barcode reader)

Standards

IEC60825-1:2007a

a. The Cell Saver Elite device complies with IEC60825-1:2007 standard, safety of laser products, equipment classification and requirements

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