Prismaflex Operators Manual Ver 5.xx May 2010

Intellectual Property Rights Copyright: © 2005–2010 Gambro Lundia AB

Trademarks: Prismaflex® is a trademark registered in Australia, China, France, Hong Kong, Russian Federation, United States, Japan, Community Trademark (EU) and South Korea in the name of Gambro Lundia AB and Gambro Industries SAS. Adsorba® is a trademark registered in Austria, Benelux, Canada, Germany, Algeria, Egypt, Community Trademark (EU), Spain, France, Great Britain, Hungary, Italy, Japan, Liechtenstein, Morocco, Monaco, Portugal, Romania, Russian Federation, Sweden, San Marino, United States, Vietnam and Serbia and Montenegro in the name of Gambro Lundia AB, Gambro Hospal (Schweiz) AG and Gambro AG. Prismaflo® is a trademark registered in Albania, Austria, Bosnia-Herzegovina, Bulgaria, Switzerland, China, Algeria, Egypt, Community Trademark (EU), France, Hong Kong, Croatia, Iceland, Morocco, Moldova, Former Yugoslav Republic of Macedonia, Mexico, Norway, Singapore, Turkey, Taiwan, Ukraine, United States, Canada and South Korea in the name of Gambro Lundia AB, Gambro Industries SAS and Hospal International Marketing Management. Prismacomfort™ is a trademark registered in Norway, Community Trademark (EU) and Switzerland and filed in United States in the name of Gambro Lundia AB. Prismatherm® is a trademark registered in United States in the name of Gambro Lundia AB. Gambro® is a registered trademark of Gambro Lundia AB. Hospal® is a registered trademark of Gambro Hospal Switzerland Ltd. MARS® is a trademark of Gambro Lundia AB registered in the United States, in the European Union and in other countries.

Patents: The Prismaflex® machine is protected by one or more of the following patents and designs: US: 5698090, 5578223, 5725775, 6177013, 6423232, 6811707, 7223338, 7247146, 7223336, 5679245, 5910252, 5776345, 5762805, 5394732, 4935141, 5139669, 5182868, 5449430, 5722399, 5644402, 7291123, 7314554, D540948 (design) EP: 0532432, 0678301, 0611228, 0829265, 0925826, 1320394, 0643301, 0305787, 0441721, 0701830, 0706044 EU (design): 15870 CA: 2077848, 2303714, 2115414, 2444794, 2158245 FR: 9111351, 9716732, 9411216, 9412252 IT: 01320264 JP: 3369223, 3413412, 3591864, 2823513, 3047403, 3254222, 3690846

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Prismaflex 1. Before you get started 2. Description of the Prismaflex System 3. General Prismaflex Functions 4. Operating the Prismaflex System 5. Continuous Renal Replacement Therapies (CRRT) 6. Therapeutic Plasma Exchange (TPE) 7. Hemoperfusion (HP) 8. Anticoagulation Methods 9. Blood Warmers 10. Alarm System 11. Troubleshooting 12. Maintenance 13. Specifications 14. Appendix A: Guidelines and Manufacturer's Declaration Electromagnetic Emissions and Immunity 15. Disposable Sets Tables 16. Index

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Chapter 1 Before you get started Contents

General Information... 1:2 Intended Use... 1:2 Contraindications... 1:2 Keywords Used in this Manual... 1:2 Where to Find Information... 1:3 Operator’s Manual... 1:3 On-line Instructions... 1:3 Instructions for Use of Prismaflex Disposable Sets... 1:3 Therapies... 1:4 Prismaflex Anticoagulation Methods... 1:4 Responsibility and Disclaimer... 1:5 Safety Definitions... 1:6 General Warnings and Cautions before Use... 1:7 Warnings... 1:7 Cautions... 1:10 Symbols... 1:11 Certification Marks... 1:14 Installation, Service and Transport... 1:14 Disposal... 1:14 Disposal of Packaging Material... 1:14 Disposal of Discarded Equipment... 1:14 Hazardous Substances... 1:15

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General Information Intended Use The Prismaflex control unit is intended for: •

Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload.

•

Therapeutic Plasma Exchange Therapy (TPE) for patients with diseases where removal of plasma components is indicated.

•

Hemoperfusion (HP) for patients with conditions where removal of toxic substances is indicated.

All treatments administered via the Prismaflex control unit must be prescribed by a physician.

Contraindications There are no known contraindications to Continuous Renal Replacement Therapies. There are no known contraindications to Therapeutic Plasma Exchange. There are no known contraindications to Hemoperfusion. For contraindications that may apply for the disposable set selected for the therapy, refer to the Instructions For Use of the disposable set.

Keywords Used in this Manual Authorized service technicians Refers to Gambro trained and certified service technicians. Filter Filter stands for: •

hemofilter/dialyzer

•

plasmafilter

•

adsorption cartridge

depending on the therapy in use. Manual Whenever the word Manual is used within this manual, it always refers to this Operator's Manual for the Prismaflex unless another is specified. Operator In this manual, an Operator designates an appropriately trained and qualified clinical staff who is in charge of the machine. The operator makes the machine settings in accordance with prescribed treatment, responds to alarms, troubleshoots the machine, handles the bags and so on.

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Screens The Prismaflex displays different screens during operation. Whenever a screen is referred to in this manual, it is identified by its title, e.g. Enter Flow Settings screen or Status screen. Softkeys Whenever a Softkey on the Prismaflex screen is referred to in this manual, it is written in capital italic letters, e.g. NEW PATIENT or CHANGE BAG.

Where to Find Information Operator’s Manual This manual provides operating, maintenance, and troubleshooting instructions, as well as general information. “Chapter 2: Description of the Prismaflex System” provides information about the Prismaflex control unit and system components. “Chapter 3: General Prismaflex Functions” describes the principles of operation of the system, notably about fluid and pressure management. “Chapter 4: Operating the Prismaflex System” explains the system interface, gives an overview of a treatment sequence and describes the routine handling steps. Specific therapy information is provided in dedicated chapters for: •

CRRT in “Chapter 5: Continuous Renal Replacement Therapies (CRRT)”

•

TPE in “Chapter 6: Therapeutic Plasma Exchange (TPE)”

•

HP in “Chapter 7: Hemoperfusion (HP)”

•

Anticoagulation in “Chapter 8: Anticoagulation Methods”

On-line Instructions Detailed operating instructions are incorporated in the software of the Prismaflex. The instructions are available on-line, through the interactive display. Instructions include the following screens: •

Operating screens (step-by-step instructions that the operator follows each time in setting up, administering, verifying settings and ending patient treatments).

•

Alarm screens (instructions when an alarm situation occurs).

•

Help screens (additional information about an Operating or Alarm screen).

Instructions for Use of Prismaflex Disposable Sets Instructions for use are provided with Prismaflex disposable sets, and provide operating flow rates, filter pressures, priming requirements, performance data and other information for use of the set with the Prismaflex system.

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Therapies The Prismaflex control unit pumps blood from the patient, through the filter in a Prismaflex disposable set, and back to the patient’s venous circulation. As the blood passes through the filter, the desired treatment processes take place. Depending on the therapy in use, these processes can include fluid removal and/or solute clearance. For instructions about the different therapies, see each respective therapy chapter. During the setup procedure, the operator selects the therapy desired. The Prismaflex system provides: CRRT – Continuous Renal Replacement Therapies; •

SCUF – Slow Continuous Ultrafiltration

•

CVVH – Continuous Veno-venous Hemofiltration

•

CVVHD – Continuous Veno-venous Hemodialysis

•

CVVHDF – Continuous Veno-venous Hemodiafiltration

CRRT SepteX – Continuous Renal Replacement Therapies with High Cut-Off membrane; •

CVVHD – Continuous Veno-venous Hemodialysis

•

CVVHD+post – Continuous Veno-venous Hemodialysis + post infusion

CRRT MARS®– Contiunous Renal Replacement Theapies supporting Molecular Adsobents Recirculation System; •

CVVHD – Continuous Veno-venous Hemodialysis

•

CVVHDF – Continuous Veno-venous Hemodiafiltration

TPE – Therapeutic Plasma Exchange HP – Hemoperfusion Note: All therapies beside CRRT require a service configuration. Contact your local representative for additional information. Note: Check your local regulations for any restrictions on therapies, disposables, solutions etc.

Prismaflex Anticoagulation Methods For detailed instructions about the different anticoagulation methods, see “Chapter 8: Anticoagulation Methods”. During the setup procedure, the operator selects the desired anticoagulation method. The Prismaflex system provides:

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•

Standard – Syringe

•

No Syringe

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•

Citrate – Calcium via External Infusion Pump

•

Citrate – Calcium via Prismaflex Syringe Pump

Note: All anticoagulation methods beside No Syringe require a service configuration. Contact your local representative for additional information.

Responsibility and Disclaimer Gambro accepts responsibility for the safety, reliability, and performance of this equipment only: •

If any modifications to the equipment are authorized in writing by Gambro and carried out by an authorized service technician.

•

If the electrical installation for powering the equipment complies with all applicable local electrical codes and requirements including, if applicable, IEC requirements.

•

If the equipment is used in accordance with this manual.

Gambro will provide on request, a service manual which contains all necessary circuit diagrams, calibration instructions, and service information to enable authorized service technicians to repair those parts of this equipment which Gambro considers to be repairable. This manual contains references to accessories and disposables for use with the Prismaflex system, see “Chapter 2: Description of the Prismaflex System” on page 2:1. The Prismaflex system has been tested and validated for use with these accessories and disposables. Gambro does not accept any responsibility or liability for use of accessories or disposables other than those specified in this manual or if any specified accessory or disposable is not used in accordance with this manual, on-line instructions and the Instructions for Use accompanying those accessories and disposables. Since Gambro has no control over service work which is not performed by authorized service technicians, Gambro will in no way be responsible or liable for any damages resulting from the operation or performance of any device, or any injury caused thereby, after repair has been performed by any person other than a factory representative of Gambro. Under no circumstances will Gambro be liable for any indirect, incidental, special or consequential damages of any kind, its liability being hereby limited solely to repair or replacement. Note: Check your local regulations for any restrictions on therapies, disposables, solutions etc.

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Safety Definitions This manual uses the following safety definitions: WARNING A warning alerts the reader about a situation which, if not avoided, could result in an adverse reaction, injury or death. WARNING CAUTION The term caution is used for the statement of a hazard alert that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. CAUTION

Note: Notes are added to give more information.

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General Warnings and Cautions before Use Warnings WARNING

General Carefully read this Prismaflex Operator’s Manual and the Prismaflex disposable set and solution bag Instructions for Use before operating this device. Note: Deviation in the classification of a Warning and a Caution between the manual and disposable IFU may occur. If found, refer to the manual. Before first use, ensure that the installation test has been successfully performed. Operate the Prismaflex control unit in accordance with this manual, the Instructions for Use of the Prismaflex disposable set and solutions, and the on-line instructions. The manufacturer will not be responsible for patient safety if the procedures to operate, maintain, and calibrate the Prismaflex system are other than those specified in this manual, the Service Manual, the Instructions for Use of the Prismaflex disposable set and solutions, and the on-line instructions. These procedures are only allowed to be performed by authorized service technicians. Procedures using the Prismaflex system must be performed under the responsibility of a physician. Service and Repairs The accuracy of the Prismaflex control unit depends on accurate scale and pressure calibration. Ensure that scales and pressure sensors are accurately calibrated. Calibrations must be performed by an authorized service technician. Calibration instructions are provided in the PrismaflexService Manual. Electrical safety Use only the Prismaflex hospital grade power cord to plug the Prismaflex control unit to the facility electrical outlet. Although all Prismaflex machines comply to IEC 60601-1 requirements for hemodialysis machines (Type BF Applied Part), it is recommended to use a Prismaflex machine Type CF Applied Part when the blood access is from a Central Dialysis Catheters (CDC). The type label at the back of the control unit indicates the classification. Note: when using the Prismaflex and MARS combination the system comply with the Type B applied part classification per IEC 60601-1 standard. Install the discharger ring in its guide before connecting a patient to the Prismaflex set in order to minimize cardiac monitor disturbance. Misinterpretation of ECG artefacts may lead to patient serious injury or death (See also Troubleshooting, chapter 11). Do not use cellular phone or other radio frequency equipment within a short distance from Prismaflex since disturbance may occur. For additional information about special precaution regarding EMC, refer to Appendix A in this manual.

The correct installation of a Medical Electrical System requires that each system component be individually connected to the main power. It is strongly recommended: Not to use multiple portable socket-outlets. However, if using multiple portable socket-outlets, they must comply with IEC 60601-1-1 Standard and must not be placed on the floor. WARNING → → →

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→ → → WARNING All electrical installations must comply with all applicable local electrical codes and the manufacturer’s specifications. Environment Do not use the Prismaflex control unit near flammable gas, or a flammable anaesthetic mixture with air, oxygen or nitrous oxide. Handling the machine Lock brakes on the wheels to limit movement of the control unit that might pull on tubing connected to the patient or significantly alter fluid balance, resulting in patient injury or death. After turning ON the control unit, verify the audible alarm and that the green, yellow and red status lights are lit alternately during Prismaflex start up sequence. In case of malfunction, switch OFF the control unit and call for Service. Accessories and remote alarms Use only the blood warmers listed in this manual. Install and operate them following the Operator’s Manual provided with the selected blood warmer. The Prismaflex makes available the treatment related data through connection to external devices (personal computer or communication network) for storage and display. The intended use of this information is to support the physicians, but it cannot be considered as the sole data to prescribe any therapeutic or pharmacological action for the patient. It is the responsibility of the physician to verify all data. The clinic/user is solely responsible for connecting a remote alarm to the Prismaflex and for verifying its function. If a remote alarm is used, the operator is responsible for periodically checking on the patient in person. Setup and priming During priming and operation, observe closely for leakage at joints and connections within the set. Leakage can cause blood loss or air embolism. If leakage cannot be stopped by tightening the connections, replace the set. Before connecting the blood return line to the patient, make sure there is no air between the segment of line inserted in the air bubble detector and the patient end of the return line. If air is present in this part of the return line, connect the access line to the 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. If there is too much air in the blood circuit, reprime the circuit completely before patient connection. Clamp unused lines after priming is complete and before starting a patient treatment according to therapy configuration. Check for the correct increment and sequential order of parameter settings when the arrow keys are pressed in Enter Flow Settings, Enter Anticogulation Settingsor Enter TPE Prescription screens. If the increment or sequence is incorrect, terminate the treatment and call for service. See “Chapter 13: Specifications” on page 13:1 for a list of the correct increments.

Blood leakage from the pressure pod diaphragm (Access and Filter) At the end of the treatment the machine must be put into a quarantine and tagged as “DO NOT USE”. Additional verification is required either by the facility’s biomedical and/or authorized service technician. WARNING → → →

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→ → → WARNING Treatment monitoring Always inspect the blood flowpath for signs of clotting before returning the blood in the set to the patient. If clotting is suspected, do not return the blood to the patient. Under normal conditions, the Prismaflex pressure transducers have proven to be safe and effective in measuring during treatment. However, in the unlikely event of a blood/infusion solution leakage from a pod diaphragm or if blood has reached the Return fluid barrier membrane, follow the instructions in “Leakage in pressure pods or blood reaching fluid barrier” on page 11:84. Although unlikely, events such as blood/infusion solution leakage from a pod diaphragm, or wetting of the monitor line fluid barrier, will impair the pressure monitoring system of Prismaflex and require immediate troubleshooting. See Chapter 11 for detailed instructions. Collecting blood samples from improper sample sites in the set can lead to incorrect blood chemistry results. Dilution effect of infusions must be considered according to the flow settings and sample sites (for example PBP infusion rate on an Access site blood sample). Wait for some minutes before taking a blood sample after pumps have been stopped, so as to get samples representative of the stabilised conditions. The control unit may not be able to detect disconnections of the set from the blood access and return connections, which can result in blood loss. Ensure that the patient's blood access and return connections are firmly secured; pay special attention in case a warmer sleeve is in use. Carefully observe the set and all operation while using the Prismaflex system for a patient treatment. Fluid management Do not hang anything except fluid bags on the scales on the bottom of the Prismaflex control unit. Foreign objects on the scales can significantly alter fluid balance, resulting in patient injury or death. The Prismaflex control unit is intended to be used on patients weighing 8 kg or more. A higher minimum patient weight limit may apply for the disposable set selected for the therapy. Refer to the Instructions For Use of the disposable set and Table “Sets and patient weight limits” on page 2:17. Fluid balance deviations, even if within the specified Prismaflex accuracy, can exceed a level that can be tolerated by low-weight patients. The Prismaflex system is unable to detect all of the situations where a bag has been attached to the wrong line or has been hung on the incorrect scale. The use of color coded lines, color coded clamps or specific label on the PBP line are intended to prevent such errors. When hanging a fluid bag, always centre it on the 3- hook assembly, so that its weight is evenly distributed. Do not support the fluid bags by any means other than the provided scale carrying bars. Fluid balance can be significantly altered, resulting in patient injury or death. Leakages from the fluid bags can significantly alter fluid balance, resulting in patient injury or death. Carefully observe the fluid bags and all operation while using the Prismaflex system for a patient treatment. “Operator-set” Patient fluid removed must be calculated multiplying Run Time in History screen by Patient fluid removal rate. WARNING → → →

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→ → → WARNING If you receive additional weight alarms and the cause cannot be identified, then consider discontinuing and restarting the treatment, if possible. Ignoring and/or indiscriminately pressing the CONTINUE softkey as a response to weight alarms may lead to incorrect patient weight loss or gain, and may result in serious patient injury or death. Always identify and solve the originating cause of a Weight alarm before pressing the CONTINUE softkey. Solutions and bags Ensure that dialysate solution and infusion solutions (PBP and replacement) are of appropriate composition and at appropriate temperature, as prescribed by a physician. Before using a solution/fluid, make sure it is free of precipitates and other particulate matter. The use of incorrect solution/fluid can result in patient injury or death. Hygienic considerations Use aseptic technique when handling the blood and fluid lines in the disposable set. Do not use the Prismaflex disposable set if the package is damaged, if the sterilization caps are missing or loose, or if the blood lines are kinked. When handling Prismaflex disposable sets, hospital personnel should take adequate precautions at all times to prevent exposure to or transmission of HIV, hepatitis virus, or other infectious agents. WARNING

Cautions CAUTION

Service and Repairs There are no operator-serviceable parts inside this device. Repairs must be performed by an authorized service technician. Only authorized service technicians can access Service mode. If Service mode is inadvertently entered, turn the unit off, then on to return to Operating mode. Do not use any type of lubricant on the internal or external components of the Prismaflex control unit or Prismaflex disposable set. Only authorized service technicians can apply lubricants to machine components. Improper use of lubricant can adversely affect performance of the control unit. Electrical safety Devices connected to the RS232 serial communication port or the Ethernet port must comply with IEC 60950. Connected cables must have a Kitagawa RFC-10 ferrite or equivalent to fulfill EMC requirements. Environment Relating to the Prismaflex set/solution storage conditions and temperature; refer to the Prismaflex set/solution Instruction for Use (IFU). Variations in room temperature of ±3 °C (5.4 °F) or more can cause the scales to become inaccurate. Handling the machine and its accessories Never insert fingers in the return line clamp or in the pinch valves. Use a 21-gauge (or smaller diameter) needle to obtain blood or fluid samples or to reposition pod diaphragms. Use of larger needles can cause holes in the sample sites, resulting in blood loss or air embolism. Use aseptic technique whenever inserting needles into sample sites. CAUTION → → →

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→ → → CAUTION After switching the machine off, wait at least 5 seconds before turning it on again. If the display goes blank while power is on, immediately terminate the treatment and call for service. Before moving the machine, check that the brake is released and ensure that all the scales are firmly closed. Setup and priming If a patient is not connected to the Prismaflex disposable set shortly after priming is complete, flush the set with at least 500 ml priming solution (saline with heparin added) before connecting a patient. This may require use of a new bag of priming solution and a new (empty) collection bag. Consult the Instructions For Use packaged with the set for details about priming volumes. Treatment monitoring Do not allow air to enter the blood compartment of the filter after priming has started. If a large amount of air enters, the set must be replaced. Due to the nature of use of the Prismaflex disposable set (low blood flow rate, extended treatment time, and other special factors), the risk of coagulation within the blood flow path is substantially enhanced. Give careful attention to the possible medical hazards associated with coagulation of the blood flow path. Fluid management In all CRRT therapies, and in contrast with previous system versions, the Prismaflex system SW 5.xx accounts for syringe infusion volumes in the Patient Fluid Removal, whatever the selected anticoagulation method. Hygienic considerations To prevent contamination, the Prismaflex disposable set must be used as soon as its package and sterilization caps are removed. Destroy the Prismaflex disposable set after a single use, using appropriate procedures for potentially contaminated material. Do not resterilize. Chemicals other than those recommended in this manual for cleaning and disinfection could damage the Prismaflex control unit and Prismaflex disposable sets. Obtain permission from the manufacturer before using a non-recommended chemical on the Prismaflex system. The following are especially forbidden: (a) halogenated aromatic and aliphatic solvents; (b) ketonic solvents. CAUTION

Symbols If applicable, the following symbols appear on or near the serial number label or other permanently affixed labels of this device. For more information, see “Chapter 13: Specifications” on page 13:1. This symbol indicates that the equipment applied part is Type BF, defibrillation proof per IEC 60601-1. Note: To be sure of the machine's classification see type label found at the back of the machine. This symbol indicates that the equipment applied part is Type CF, defibrillation-proof per IEC 60601-1. Note: To be sure of the machine's classification see type label found at the back of the machine.

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This symbol indicates that consultation of the accompanying documents prior to equipment operation is critical to the safe operation of the device. The background colour is white. This symbol indicates that consultation of the accompanying documents prior to equipment operation is critical to the safe operation of the device. The colours are blue and white. Note: This symbol is a complement to the warning triangle symbol. This symbol indicates that the device meets the “drip proof” classification requirements. This symbol indicates that the device requires an alternating supply current. This symbol indicates that conductors carrying high voltage are nearby and that these could be hazardous if contacted.

This symbol is located near functional ground locations on this device.

This symbol is located near protective ground locations on this device.

This symbol identifies the point of connection of a potential equalization conductor.

This symbol indicates a fuse. This symbol indicates that certain components within this equipment are sensitive to electrostatic discharge. This symbol indicates the date of manufacture. It is accompanied by the year expressed as four digits.

This symbol indicates the manufacturer. The year of manufacture may be included in the symbol expressed as four digits.

This symbol indicates the presence of an Ethernet port.

This symbol indicates the presence of an RS232 Serial Communication port.

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This symbol indicates the presence of a remote alarm connection.

This symbol indicates that: – since the equipment contains dangerous substances, it must not be disposed together with other municipal waste. It must be recycled; – the equipment was placed on the market after 13 August 2005. This symbol is a warning label not to lean the machine more than 5° from the floor. Note: This warning label must be applied on the warmer holder before use. It should be mounted on deliverance. The background colour is yellow. The Prismaflex control unit contains hazardous substances. See Table Hazardous Substances on page 1:15. The environmental protection use period is 25 years.

Recycle the cardboard.

Fragile – handle with care.

Keep dry.

The maximum stacking load permitted on the transport package is 100 kg.

This way up

Pull out scale completely before hanging bag.

Pull out scale completely before hanging bag.

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Certification Marks The CE-conformity mark indicates that the Prismaflex control unit conforms to the requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices. It also indicates that the notified body British Standards Institution (BSI, No. 0086) has approved the Quality Management System. The CE conformity mark is only valid for the Prismaflex control unit. Disposables and any accessories specified for use with the Prismaflex control unit are marked with CE conformity marks in their own right. (See “Prismaflex Disposable Sets” on page 2:16.) The CSA (C-US) mark indicates that the Prismaflex control unit conforms to the requirements related to safety of medical devices for the US and Canada. The “C” and the “US” adjacent to the CSA mark indicate that the Prismaflex control unit has been evaluated to the applicable ANSI/UL and CSA standards for use in the US and Canada. The CCC mark indicates that the Prismaflex control unit conforms to the safety requirements for China Compulsory Certification (CCC) as described by the competent authority Certification and Accreditation Administration of People's Republic of China (CNCA). The “S” adjacent to the CCC mark indicates that safety requirements are met.

Installation, Service and Transport Please note that Prismaflex has to be installed by an authorized service technician. For installation information, see Prismaflex Service Manual. For technical assistance, contact your local representative. CAUTION Do not connect a patient to the Prismaflex system during the installation test. Be sure that the test is conducted using a container of water to substitute for the patient. The Prismaflex control unit weighs approximately 60 kg (132 lb). Use at least two people to lift it out of the shipping carton. Handle the control unit carefully. Prior to using the Prismaflex control unit, let the unit rest at ambient operating temperature for 1 hour. CAUTION

Disposal Disposal of Packaging Material The Prismaflex control unit shipping carton, foam packing, and other packaging material should be disposed of according to local regulations.

Disposal of Discarded Equipment Discarded electromedical equipment must not be disposed of together with municipal waste but must be collected separately in order to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment.

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Pay attention to the fact that some components of the machine (display, batteries, circuit boards, etc.) may contain toxic substances which, if released into the environment, pose a risk to the health of living organisms and the environment itself.

Hazardous Substances Hazardous Substances Part

Hazardous substances Hexavalent chromium (Cr6+)

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Printed circuit board assemblies

X

O

O

O

O

O

Electromechanical components including wiring

X

O

O

O

O

O

Power supply

X

O

O

O

O

O

Batteries

X

O

O

O

O

O

Metals

O

O

O

O

O

O

Plastics

O

O

O

O

O

O

Enclosures

O

O

O

O

O

O

Polybrominated biphenyls (PBB)

Polybrominated diphenyl ethers (PBDE)

O: Indicates that the concentration of the hazardous substance in all homogeneous materials of the part is below the SJ/T 11363-2006 limit (Chinese regulation). X: Indicates that the concentration of the hazardous substance in at least one homogeneous material of the part is above the SJ/T 11363-2006 limit (Chinese regulation).

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