prisma therm Blood Warmer Operators Manual rev 0 March 2006

INSTRUCTIONS FOR MEDICAL USE <according to the Medical Safety/EMC standard IEC/EN 60601-1-2>

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.

Stihler Electronic GmbH, Stuttgart, Germany, declares itself to be solely responsible for this product meeting the requirements of Council Directive 93/42/EEC, dated June 14, 1993, regarding medical products. (230240 volts Prismatherm II) Designation location: DEKRA Certification GmbH, license number 0124.

Questions or comments about this publication can be directed to your local representative or to: GAMBRO LUNDIA AB, Monitor Division, Box 10101, SE-220 10 Lund, SWEDEN.

Contents Before You Get Started ...5 Indications ...5 Contraindications ...5 Shipping Carton Contents ...5 Warnings ...5 Precautions ...7 Symbols and Certification...8 International Standards and Classification ...9 Disclaimer ...9 Warranty...9 Service Information ...10 Device Disposal ...12 Return of Used Product...12 Chapter 1: Product Description...13 Introduction ...13 Technical Description ...13 Thermal Response ...14 Pressure Effects...15 Blood Warmer Components ...16 Control Panel Components ...17 Chapter 2: Installation ...18 Installation Parts...18 Install the Holder ...18 Position the Blood Warmer...20 Chapter 3: Operation ...21 Introduction ...21 Load the Extension Line...21 Connect the Extension Line to PRISMAFLEX Set ...23 Prime the Extension Line ...24 Before Starting Treatment ...24 Conduct Treatment ...24 End Procedures ...25 Chapter 4: Alarm System and Troubleshooting...26 Alarm System...26 Troubleshooting ...27 Chapter 5: Maintenance and Periodic Safety Inspection ...29 Service ...29 Preventive Maintenance...29 Cleaning and Disinfection...29 Periodic Safety Inspection...30 Chapter 6: Specifications...32 Chapter 7: EMC Guidance and Manufacturer's Declaration...33

Prismatherm II Blood Warmer Operator’s Manual

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Figures Figure 1. Temperature Graphs ...14 Figure 2. Typical Pressure Drop in the Extension Line...15 Figure 3. Prismatherm II Blood Warmer...16 Figure 4. Control Panel ...17 Figure 5. Installing the Holder and Prismatherm II to the PRISMAFLEX Control Unit ...19 Figure 6. Functional Positions of the Prismatherm II Blood Warmer ...20 Figure 7. Loading the Extension Line ...22 Figure 8. Connecting the Extension Line to the PRISMAFLEX Set...23

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Prismatherm II Blood Warmer Operator’s Manual

Before You Get Started The Prismatherm II Blood Warmer is used to warm the return blood flow in order to replace heat lost to the atmosphere and effluent flow1 during a PRISMAFLEX System treatment. The Prismatherm II Blood Warmer is designed for use with the Prismatherm II Extension Line, PRISMAFLEX Control Unit, and the appropriate PRISMAFLEX Set for the therapy in use.

Indications The Prismatherm II blood warmer may be used during delivery of any PRISMAFLEX therapy, when heat loss may cause undesirable cooling of the patient.

Contraindications There are no known contraindications to warming the return blood flow during delivery of PRISMAFLEX System therapies.

Shipping Carton Contents The shipping carton contains the following items. •

Prismatherm II Blood Warmer with attached power cord

•

Heat protection sleeve attached to warmer

•

Prismatherm II Blood Warmer Operator’s Manual

Warnings 1. Danger - Explosion Hazard. Do not use the Prismatherm II Blood Warmer in an explosive atmosphere. 2. Before operating this device, carefully read this Prismatherm II Blood Warmer Operator’s Manual and the Prismatherm II Extension Line Instructions for Use. You should also be thoroughly familiar with the PRISMAFLEX System Operator’s Manual and the PRISMAFLEX Set Instructions for Use.

1.

Effluent flow includes ultrafiltrate and/or spent dialysate.

Prismatherm II Blood Warmer Operator’s Manual

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3. The use of procedures other than those published in this manual can result in patient injury or death. Operate and maintain this device only in accordance with the procedures given in this Prismatherm II Blood Warmer Operator’s Manual. The manufacturer will not be responsible for patient safety if procedures other than those published are used. 4. Electrical installations must comply with all applicable local electrical codes and the manufacturer’s specifications. 5. Persons who operate and maintain this device must be appropriately trained and qualified. 6. WARNING: No modification of the ME EQUIPMENT is allowed. 7. Use only the Prismatherm II Extension Line SP-420 with the Prismatherm II Blood Warmer. The use of other extension lines can result in inadequate performance of the blood warmer and patient injury or death. 8. It is recommended that particular attention must be paid with respect to the total extra-corporeal blood volume (PRISMAFLEX Set + Prismatherm II extension line) when including Prismatherm II into the PRISMAFLEX blood circuit. 9. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. Do not remove the rear part of the Prismatherm II housing. 10. Addition of the Prismatherm II Extension Line to the PRISMAFLEX Set increases the filter and effluent pressures and affects the pressure calculations done by the PRISMAFLEX Control Unit. See “Pressure Effects” in the Product Description chapter of this manual for more information. 11. If a High Temperature alarm (red alarm light, audible beep) occurs, do the following: •

Verify the Prismatherm II safety system has disabled the heater and temperature is dropping below 42 °C. If temperature is not dropping, stop the PRISMAFLEX blood pump to prevent blood from returning to the patient.

•

Evaluate possible causes for the alarm. See the Alarm System and Troubleshooting chapter for more information. If necessary, discontinue use of the blood warmer. 12. The power cord must be removed from the electrical wall outlet to completely remove electrical power to the device. 13. The manufacturer will not be liable for user/patient safety if measures other than those specified by the manufacturer are applied in use, servicing and safety checks. Persons performing such measures must be appropriately qualified and trained. 14. In the case of several appliances being combined and connected (e.g. at multiple sockets), the sum of the leak currents must not exceed the permissible limit value.

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Prismatherm II Blood Warmer Operator’s Manual

Precautions 1. Procedures using the Prismatherm II Blood Warmer must be performed under the responsibility of a physician. 2. If for any reason the Prismatherm II Blood Warmer must be returned to the local distributor, it is the responsibility of the health care institution to adequately prepare and identify the product for return shipment. 3. The Prismatherm II Blood Warmer contains no user-serviceable parts. Do not attempt to repair the Prismatherm II Blood Warmer yourself. Contact the local distributor for service or technical information. See “Service Information” in this chapter. 4. To reduce the risk of patient or operator injury, do not use the Prismatherm II Blood Warmer if any of the following conditions exist: •

Damaged or worn-out power cord, plug, or receptacle

•

Damaged housing or control panel

•

Warmer has been dropped or had liquid spilled on its internal electronics

•

Warmer is not heating correctly as indicated by visible or audible alarms

•

Red alarm light and/or audible alarm beep fail to activate when the Power button (on the control panel) is pressed

5. Do not use the Prismatherm II Extension Line if the package is damaged or the end caps are not in place. 6. The blood pathway of the Prismatherm II Extension Line is sterile and nonpyrogenic. To prevent contamination, use the extension line as soon as it is removed from the package. Use aseptic technique when connecting the extension line to the PRISMAFLEX Set. 7. Destroy the Prismatherm II Extension Line after single use, using appropriate procedures for potentially contaminated material. Do not resterilize. During treatment, change the Prismatherm II extension line whenever the PRISMAFLEX set is changed. 8. When handling the Prismatherm II Extension Line, take adequate precautions to prevent exposure to infectious agents. 9. Ensure all connections are secure and free of kinks before priming the PRISMAFLEX Set and Prismatherm II Extension Line. 10. Before pressing the START softkey on the CONNECT PATIENT screen, ensure that the fluid in the PRISMAFLEX Set and Prismatherm II Extension Line is free of air bubbles. 11. When plugging in the warmer be sure the power cord does not touch the scale hooks or fluid bags on the PRISMAFLEX Control Unit. Contact with the scales or bags during treatment can cause nuisance alarms.

Prismatherm II Blood Warmer Operator’s Manual

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Symbols and Certification The following symbols appear on or near the serial number label or other permanently affixed labels of this device. See the Specifications chapter for more information. Indicates that the equipment applied part is Type B, defibrillation proof per electrical safety standards IEC 60601-1 and VDE 0750, Part 1. Indicates that consultation of the accompanying documents prior to equipment operation is critical to the safe operation of the device. Indicates that the device is protected against splashing water, in accordance with IEC 60529. Indicates an alarm condition when accompanying light is red. See Figure 4, Control Panel. Indicates Standby state when accompanying light is orange. See Figure 4, Control Panel. Switches between Power On and Standby state. Power is on when accompanying light is green. See Figure 4, Control Panel. Starts the heater. Heater is on when accompanying light is green. See Figure 4, Control Panel. Increases the temperature setting.

Decreases the temperature setting.

Precedes the 4-digit year of manufacture of the equipment.

Indicates the manufacturer. Indicates that the equipment conforms to Council Directive 93/42/EEC, of 14 June, 1993 relating to Medical Devices. Also indicates that the notified body which has approved the manufacturer’s quality system is DEKRA Certification GmbH. The affixed CE Mark covers only the Prismatherm II Blood Warmer. Disposables specified for use with this device have separate CE Marks. See Warning number 7. Indicates that the device is classified by UNDERWRITERS LABORATORIES INC. with respect to electric shock, fire and mechanical hazards only in accordance with UL2601-1 and CAN/CSA C22.2 No. 601-1. The control number assigned for this file is 75JA.

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Prismatherm II Blood Warmer Operator’s Manual

International Standards and Classification IEC 60601-1 (1988) Medical electrical equipment - Part 1: General requirements for safety. IEC 60601-1-2 (2004) Medical electrical equipment - Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements and tests. The device is Class IIb in accordance with European Directive 93/42/EEC for medical equipment. Year of approval for marking with CE 0124 label: 2006. UL 60601-1 (2003) Medical Electrical Equipment, Part 1: General Requirements for Safety. CAN/CSA-C22.2 No. 601.1.1 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems. ASTM F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers.

Disclaimer The manufacturer and/or subsidiaries accepts responsibility for the safety, reliability, and performance of this equipment only if the operating, maintenance, and calibration procedures are those specified by the manufacturer; the persons performing the procedures are appropriately trained and qualified; genuine parts are used when replacement of spare and component parts is required; assembly operations, extensions, adjustments, modifications, or repairs are carried out by persons or service canters authorized by the manufacturer; all electrical installations comply with the applicable local electrical codes and IEC requirements; and if the equipment is used in accordance with the published instructions for use (this document), for the purpose intended, and in the appropriate environment.

Warranty During the warranty period, defects in materials or workmanship will be corrected by either repair or replacement of the device at no cost to the customer. Other damages are not covered by this warranty. No claims for warranty will be recognized in cases of abuse or misuse, use of force, or damages due to normal wear and tear. No claims for warranty will be recognized for modifications or other actions by persons not authorized by the manufacturer. In case of claims under this warranty, return the device to the nearest local distributor. (See “Service Information” below.) Packaging and shipping costs are the responsibility of the customer.

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Service Information

WARNING

The Prismatherm II Blood Warmer contains no user serviceable parts. Do not attempt to repair the Prismatherm II Blood Warmer yourself. Contact the local distributor for service or technical information.

For service or technical assistance contact the local distributor at the appropriate address below.

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AUSTRALIA

GAMBRO PTY Ltd. 11-13 King Street Oakleight VICTORIA 3166 Tel. 61-395633400 Fax 61-395630344

AUSTRIA

GAMBRO HOSPAL Gmbh Ricoweg 30 A 2351 Wr. NEUDORF Tel. 43-223664666 Fax 43-22366466655 E-mail [email protected] Web www.gambro.at

BELGIUM

GAMBRO NV/SA 15, Groenveldstraat BE-3001 HEVERLEE Tel. 32-16298750 Fax 32-16226521

CANADA

GAMBRO Inc 9157, du Champ d´Eau CDN St. Leonard, QUEBEC H1P 3M3 Tel. 1-5143271635 Fax 1-5143270822

DENMARK

GAMBRO A/S Jydekrogen 8 2625 VALLENSBAEK Tel. 45-436050 Fax 45/43620749

ESTONIA

GAMBRO ESTONIA Raudtee 10-1 11614 TALLINN Tel. 372-6723160 Fax 372-6723161

FINLAND

OY GAMBRO Sahaajankatu 24 00810 HELSINKI Tel. 358-97594120 Fax 358-9781146

FRANCE

HOSPAL S.A 61 av. Tony Garnier 69007 Lyon Tel. 33-0437281111 Fax 33-0437281144

GERMANY

Gambro Hospal GmbH Lochhamer Str. 15 82152 Planegg-Martinsried Tel. 49-8989933-0 Fax 49-8989933-2999

HONG KONG

GAMBRO CHINA Ltd Room 3206-8,32/F New York Life Tower Windsor House 311 Gloucester Road , Causeway Bay Tel. 852-25762688 Fax 852-26871255

HUNGARY

GAMBRO Kft Diosarok ut 5 1125 BUDAPEST Tel. 36-12026411 Fax 36-13552989

ITALY

HOSPAL S.p.A Via Ferrarese, 219/9 40128 Bologna Tel. 39-0516382411 Fax 39-051327477

LATVIA

GAMBRO LATVIA P.O Box 207 1050 RIGA Tel. 371-921999 Fax 371-5030116

LITHUANIA

Gambro Atstovybe Kareiviu 6-406 2012 Vilnius Tel./Fax 370-2776151

Prismatherm II Blood Warmer Operator’s Manual

MEXICO

GAMBRO de MEXICO S.A de CV Vasco de Quiroga 1900, piso 3 MX-Santa Fe MEXICO D. F. 01210 Tel. 52 /52 92 31 00 Fax 52 /52 92 31 13

NETHERLANDS

GAMBRO HOSPAL BV Franse Akker 1 4824 AL BREDA Tel. 31-765303600 Fax 31-76 5411968

NORWAY

GAMBRO A.S Blixjordet, Trimveien 3188 HORTEN Tel. 47-33 03 08 50 Fax 47-33 03 08 65

NEW ZEALAND

GAMBRO Pty Ltd 5B Target Court Glenfield AUCKLAND Tel. 64-94444779 FAX 64-94432222

POLAND

GAMBRO POLAND sp. Zoo ul Floriana 5 04664 WARSAW Tel. 48-226130012 Fax 48-398120468

PORTUGAL

GAMBRO Lda Av. Salgueiro Maia- 9 Parque Industrial Cotai Abóboda 2785-601. S. Domingos Rana Tel. 351-214450280 Fax 351-214444216

SWEDEN

Gambro Lundia AB /Gambro Svenska Försäljning Krokslätts Fabriker 14 431 37 Mölndal Tel. 46-317769353 Fax 46-317769340

SINGAPORE

GAMBRO SINGAPORE 510 Thomson Road #12-05 /06 SLF Building SINGAPORE 298135 Tel. 65-3569670 Fax 65-3569671

SPAIN

HOSPAL S.A Avda. de la Industria, 16 28820 Coslada (Madrid) Tel. 34-914852540 Fax 34-914852610

SWITZERLAND

HOSPAL GAMBRO SCHWEIZ AG Sägereistrasse 24 8152 GLATTBRUGG Tel. 41-18288282 Fax 41-18288283

UNITED KINGDOM

HOSPAL GAMBRO Ltd Unit 1 & 2, Ermine Business Park Huntingdon CAMBRIDGESHIRE PE29 Tel. 44-1480444000 Fax 44-1480434084

USA

GAMBRO Renal Care Products,Inc 10810 West Collins Ave. LAKEWOOD CO 80215-4498 Tel. 1-8005252623 Tel. 1-30323268 00 Fax 1-3032314032

REST of EUROPE, AFRICA & MIDDLE EAST

GAMBRO EXPORT Magistratsvagen 10 P.O. Box 10101 S - 220 10 Lund Middle East: Tel. 46-46169134 Africa: Tel. 46-46169270 Russia: Tel. 46-46169171 East Europe: Tel. 46-45169171

Prismatherm II Blood Warmer Operator’s Manual

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Device Disposal The meaning of the symbol on the product, packaging or operator’s manual: Electrical appliances are valuable products and should not be thrown in the dustbin when they reach the end of their serviceable life! Please follow regional regulations on the disposal of old appliances or send the old cleaned and disinfected appliance to STIHLER ELECTRONIC or to your local distributor with an explanatory note. So it is ensure your old appliance will be disposed cheaply and properly.

Return of Used Product

WARNING

It is the responsibility of the health care institution to adequately prepare and identify the product for return shipment.

If for any reason this product must be returned to the local distributor, a returned goods authorization may be required before shipping. Contact the local distributor before returning any used product. If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before packing. (See “Cleaning and Disinfection” in the Maintenance and Periodic Inspection chapter.) The product should be shipped in the original or an equivalent carton to prevent damage during shipment.

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Prismatherm II Blood Warmer Operator’s Manual

Chapter 1: Product Description In this Chapter... •

Description of how the blood warmer operates.

•

Effects of the blood warmer on the PRISMAFLEX System during a patient treatment.

•

Explanation of the components of the blood warmer.

Introduction The Prismatherm II Blood Warmer is an accessory device for use with the PRISMAFLEX Control Unit and appropriate PRISMAFLEX Set for the therapy in use. The Prismatherm II Blood Warmer heats the return blood flow during a PRISMAFLEX System treatment in order to replace heat lost to the atmosphere and effluent flow. The blood warmer may be used during delivery of any PRISMAFLEX System therapy. A Prismatherm II Extension Line (SP420) must be used with the Prismatherm II Blood Warmer. The extension line wraps around the grooves of the warmer’s heat exchanger and connects at both ends to the return line of the PRISMAFLEX Set. During operation, the patient’s blood flows out of the upper part of the return line, through the extension line where it is warmed, then into the deaeration chamber, through the air bubble detector, and back to the patient.

Technical Description The Prismatherm II Blood Warmer operates independently of the PRISMAFLEX Control Unit. There is no electronic interconnection between the two devices. The blood warmer has three operator-selectable temperature settings: 38 °C, 41 °C, and 43.5 °C. The heat exchanger temperature is controlled to the operator-selected set point by a feedback control system. The heat exchanger temperature and internal heater are also monitored by an independent alarm system. This system alerts the operator to any alarm conditions and overrides the heater control system in the case of over temperature conditions. For more information on the temperature alarms, see the Alarm System and Troubleshooting chapter. During operation of the blood warmer, heat is transferred from the internal heater element to the heat exchanger cylinder, then through the wall of the Prismatherm II Extension Line, and to the blood flowing through the line. The blood warmer’s thermal sleeve is placed over the heat exchanger and extension line to reduce heat loss from the warmer to the atmosphere and to improve the efficiency of the warming process.

Prismatherm II Blood Warmer Operator’s Manual

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Thermal Response During operation, the Prismatherm II Blood Warmer controls the heat exchanger, so that its temperature stays at the operator-selected setting. The heat exchanger temperature is continually indicated in the “Current Temperature” display on the control panel. The blood warmer does not control or monitor the actual temperature of the return blood flow. The return blood temperature can vary according to additional factors not related to the blood warmer. These factors include room temperature, replacement and/or dialysate solution temperatures, characteristics of the patient’s blood, and the PRISMAFLEX System flow rates. Return blood flow temperature is always lower than the heat exchanger temperature unless blood flow is stopped. If blood flow is stopped, the temperature of the blood in the extension line will increase close to the temperature of the heat exchanger. Under some conditions, such as a cold room, cold fluids, or high flow rates, the warmer may not be able to provide sufficient warming to prevent cooling of the patient. Modifying the room or fluid temperatures, or reducing flow rates may be required. 44 Temperature, °C

Inlet Temperature: 10 °C

Set: [ °C]

40 36

43,5 43.5

32

41

28

38

24 20 0

20

40

60

80

100

Blood Flow Rate, ml/min

44 Temperature, °C

Inlet Temperature: 20 °C

Set: [ °C]

40 36

43,5 43.5

32

41

28

38

24 20 0

100

200

300

400

Inlet Temperature: 36 °C

Temperature, °C

Blood Flow Rate, ml/min

44

Set: [ °C]

42 43,5 43.5 40

41 38

38 36 0

100

200

300

400

Blood Flow Rate, ml/min

Figure 1. Temperature Graphs - 14 -

Prismatherm II Blood Warmer Operator’s Manual

Pressure Effects Use of the Prismatherm II Blood Warmer/Extension Line causes increases in the filter and effluent pressures in the PRISMAFLEX Set, as compared to the same operating conditions without the blood warmer. These increases (proportional to the set flow) are seen as higher Filter and Effluent values on the PRISMAFLEX Status screen. The access and return pressures are unaffected by use of the blood warmer. In most cases, the increases in filter and effluent pressures are negligible and do not affect normal use of the PRISMAFLEX System. However, the increases do cause small changes in the calculations made by the PRISMAFLEX Control Unit for filter pressure drop and transmembrane pressure (TMP)2. The effects of these changes are as follows. Increased Filter Pressure Drop Filter Pressure Drop = Filter Pod Pressure – Return Pressure The calculated filter pressure drop is increased by the amount of pressure drop in the extension line. This may increase the occurrence of Warnings “Filter Pressure Extremely Positive” or “Filter is clotted" alarms. To avoid these alarms, reduce the blood flow rate. Increased Transmembrane Pressure (TMP) TMP = (Filter Pod Pressure + Return Pressure) / 2 – Effluent Pod Pressure The calculated transmembrane pressure (TMP) is increased by half the amount of pressure drop in the extension line. This may speed up occurrence of the “Caution: TMP EXCESSIVE” alarm. To avoid risk of filter damage, promptly respond to any Advisory: TMP TOO HIGH alarm. The following graph shows the typical pressure drop in the extension line for various blood flow rates using bovine blood - hematocrit 32%. Actual pressure drop will vary with blood viscosity. 120

Pressure Drop, mmHg

100 80 60 40 20 0 0

100

200

300

400

Blood Flow Rate, ml/min

Figure 2. Typical Pressure Drop in the Extension Line

2.

Filter pressure drop and TMP are displayed on PRISMAFLEX Operating screens. For more information, see the PRISMAFLEX System Operator’s Manual.

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Blood Warmer Components (See Figure 3, Prismatherm II Blood Warmer.) Provides buttons and an LED display by which the operator 1 Control panel controls the Prismatherm II Blood Warmer. See "Control Panel Components" in this chapter for more information. Covers the heat exchanger and the Extension Line. (The extension line is loaded into the grooves of the heat exchanger.) Retains the heat that is transferred through the exchanger.

2

Thermal sleeve

3

Heat exchanger Transfers heat from the internal heater to the Prismatherm II (under sleeve) Extension Line.

4

Power cord

Conveys electricity from the wall power supply to the blood warmer.

5

Metal mount

Attaches the Prismatherm II Blood Warmer to the holder which is attached on the backside of the PRISMAFLEX Control Unit.

6

Sleeve grips

Two handles on the thermal sleeve; used to open the sleeve so that it can be moved on or off the heat exchanger.

7

Tubing holders (front and rear)

Plastic tabs at the front and rear of the blood warmer. Hold the Prismatherm II Extension Line in place on the heat exchanger.

8

Test port

Small hole at rear of blood warmer. Used to perform the temperature accuracy test during Periodic Safety Inspection procedures.

3 Heat exchanger

7 Tubing holder (rear)

6 Sleeve grips

5 Metal mount 7 Tubing holder (front) 4 Power cord

. 8 Test port

2 Thermal sleeve (covering heat exchanger) 1 Control panel

Figure 3. Prismatherm II Blood Warmer

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Prismatherm II Blood Warmer Operator’s Manual

Control Panel Components (See Figure 4, Control Panel.) Arrow buttons that allow you to select the desired heat 1 Temperature exchanger temperature. Select buttons Note: After selecting a temperature, you must confirm by pressing the Heater Start button within 5 seconds; otherwise, temperature selection reverts to the prior setting. • Starts the internal heater. The following actions occur: 2 Heater Start - Heater light (green) goes to steady illumination button - Power light (green) stays illuminated - Alarm light (red) flashes until heat exchanger warms up Note: To start the heater, press and hold the button for 1 second. An audible clicking indicates an internal relay test is occurring. • Activates new temperature selections after the set point is changed. Indicates internal heater is heating the heat exchanger; flashes 3 Heater light (green) to indicate a new temperature selection has been made. Switches between Standby state and Power On. With Power 4 Power button On the following actions occur: - Power status light (green) illuminates - LED display illuminates - Alarm light (red) flashes on and off - Audible alarm beeps - Heater light (green) flashes on and off - Selected temperature is set at the default setting. Note: To switch between Power On and Standby state, press the button for 1 second. Indicates the power is On. 5 Power light (green) 6 Alarm light (red) Indicates an alarm situation is occurring. Indicates the power cord is plugged in and the device is in 7 Standby light (orange) Standby state. Shows the three possible heat exchanger temperatures which 8 Temperature you may select. The current choice is indicated by a flashing selection box around it. display Shows the present temperature of the heat exchanger. 9 Current temperature display 9 Current temperature display

1 Temperature Select buttons

2 Heater Start button

8 Temperature selection display

3 Heater light (green)

7 Standby light (orange)

4 Power button 6 Alarm light (red)

5 Power light (green)

Figure 4. Control Panel Prismatherm II Blood Warmer Operator’s Manual

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Chapter 2: Installation In this Chapter... •

How to install the holder to the PRISMAFLEX backside.

•

How to attach the blood warmer to the holder.

•

How to move the blood warmer into its Transport, Load, and Operating positions. • Read these Installation Instructions and the Prismatherm II Blood Warmer Operator’s Manual before starting installation.

WARNING

• Electrical installations must comply with all applicable local electrical codes and the manufacturer’s specifications (see Specifications chapter).

Installation Parts The holder shipping carton contains all necessary installation parts (screws, caps and tools) for the installation of the holder to the PRISMAFLEX and the installation of the warmer to the holder. The holder has a separate order no. G 5002301.

Install the Holder (See Figure 5, Installing the Holder and Prismatherm II to the PRISMAFLEX Control Unit.) 1. Remove all items from the shipping cartons. 2. Remove 4 plastic screws and remove the pocket at the backside of the PRISMAFLEX Control Unit (Fig. 5-A). 3. First place the fixing plate of the holder and second the pocket to the backside of PRISMAFLEX and fix both with the attached longer metallic screws (Fig. 5-B). 4. Position the holder so that it is at a 90 degree angle to the control unit. The spring knob will snap into an index hole in the rotation arm. 5. Attach the Prismatherm II Blood Warmer by putting the black metal mount (rear of device) on the end of the holder (Fig. 5-C). 6. Fix the Warmer to the holder by tightening the two screws (Fig. 5-D) and close the screw holes with included plastic caps.

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Prismatherm II Blood Warmer Operator’s Manual

7. Fix the power supply cord with the clip which is attached to the holder (Fig. 5-E). 8. Store the Prismatherm II Blood Warmer in the Transport position until ready to use. (See “Position the Blood Warmer”,Fig. 6)

A

B

C

D

E

Figure 5. Installing the Holder and Prismatherm II to the PRISMAFLEX Control Unit

Prismatherm II Blood Warmer Operator’s Manual

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Position the Blood Warmer (See Figure 6, Functional Positions of the Prismatherm II Blood Warmer.) The blood warmer should be positioned according to its present use. The Transport position is used while moving the PRISMAFLEX Control Unit with attached blood warmer to a new location. The load position is used while loading the Prismatherm II Extension line onto the heat exchanger of the blood warmer. The operation position is used while conducting patient treatment. To move the Prismatherm II Blood Warmer into various positions, lift the spring knob(s) on the holder with one hand and swivel the holder with the other hand.

Load Position

Transport Position

Operating Position

Figure 6. Functional Positions of the Prismatherm II Blood Warmer

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Prismatherm II Blood Warmer Operator’s Manual