TherMax Operators Manual Ver 1.XX Rev A Nov 2018

TherMax Operator's Manual

Operator's Manual

Program version: 1.XX Order number: AW7006

2Trademarks TherMax and Baxter are trademarks of Baxter International Inc Legal Manufacturer

Baxter Healthcare SA 8010 Zurich Switzerland

AW7006 Rev A NOV2018 Program version: 1.XX

Table of c ontents - 3

Get to know TherMax

7

Installing onto the PrisMax holder | Positioning TherMax | Operating modes | Maintenance and testing

Operating TherMax

15

Blood warmer set up | Loading the disposable | Connecting the disposable | Priming the disposable | Running the treatment | Stopping the treatment | Cleaning and disinfecting

Alarms

27

Alarm, cause, and corrective action | Power failure

General information

31

General information | Specification of application | Carton content | Important safety information | Symbols | Certification marks | Warranty terms | Liability | Disposal information | Returning a used product | Service information

Device description

49

About the functions | Pressure effects | Thermal response | Technical description | About the components

Specifications

57

Environmental | Physical | Hardware | Medical device classification | Power | Electrical safety | External interfaces | Heating | Compliance | Guidelines and manufacturer’s declaration

Glossary Glossary

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73

4 - Table of contents

AW7006 Rev A NOV2018 Program version: 1.XX

Get to know TherMax - 5

Chapter 1

Get to know TherMax Installing onto the PrisMax holder

7

Positioning TherMax

9

Operating modes

10

Maintenance and testing

10

Preventative maintenance ... 10 Periodic safety inspection ... 11

AW7006 Rev A NOV2018 Program version: 1.XX

6 - Get to know TherMax

AW7006 Rev A NOV2018 Program version: 1.XX

Get to know TherMax - 7

Get to know TherMax Installing onto the PrisMax holder Before you start Before operating the TherMax blood warmer for the first time, visually inspect the equipment. Installation of the blood warmer must be performed by trained personnel. National regulations may require other tests before this equipment can be put into service. If more electrical safety tests are required, carry them out according to section "Periodic safety inspection", page 11. NOTE! The TherMax blood warmer is mounted by means of a special warmer holder to the PrisMax system. This holder has to be ordered separately. The holder shipping carton contains all installation parts, tools, and instructions for the installation of the holder to the PrisMax system.

AW7006 Rev A NOV2018 Program version: 1.XX

8 - Get to know TherMax Instructions 1. Make sure the warmer holder is correctly installed. 2. Position the warmer holder in its Operating position (see figure "Operating position of the TherMax blood warmer", page 9). 3. Attach the blood warmer to the warmer holder by sliding the aluminum attachment device, located on the blood warmer, onto the warmer holder bracket (see figure "Installing the TherMax blood warmer on the PrisMax system", page 8).

Figure Installing the TherMax blood warmer on the PrisMax system 4. Secure the blood warmer to the warmer holder by tightening the two screws (see figure "Bottom view of installing the TherMax blood warmer", page 8).

Figure Bottom view of installing the TherMax blood warmer

AW7006 Rev A NOV2018 Program version: 1.XX

Get to know TherMax - 9

Positioning TherMax The TherMax blood warmer must be positioned according to its present use, see images below: • The Operating position is used while conducting patient treatment.

Figure Operating position of the TherMax blood warmer • The Transport position can be used while moving the PrisMax system through doors with the attached blood warmer.

Figure Transport position of the TherMax blood warmer To move the blood warmer into its different positions, pull the spring knob on the warmer holder with one hand, and swivel the warmer holder with the other hand. The PrisMax warmer holder arm swings up.

AW7006 Rev A NOV2018 Program version: 1.XX

10 - Get to know TherMax

Operating modes

Figure TherMax control panel 1. Power button Switches the 2. Heating LED Illuminates green TherMax blood warmer when the blood warmer is between Standby mode and On heating. mode. During Standby mode the LED illuminates yellow when the blood warmer is connected to AC (mains) power. During On mode the LED illuminates green. 3. Service LED Illuminates red when there is an issue with the device.

Maintenance and testing Preventative maintenance The TherMax blood warmer needs no preventative maintenance. A periodic safety inspection shall be carried out according to section "Periodic safety inspection", page 11.

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Get to know TherMax - 11

Periodic safety inspection A periodic safety inspection, performed by an authorized service technician is recommended every 12 months. This inspection must be carried out at least every 24 months to ensure safe operation of the blood warmer. Ensure that all the applicable national directives, for example, IEC/EN 62353, for checking the safety of medical equipment are observed and that the test equipment is correctly calibrated. More information about the periodic safety inspection is available in the TherMax service manual.

AW7006 Rev A NOV2018 Program version: 1.XX

12 - Get to know TherMax

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Operating TherMax - 13

Chapter 2

Operating TherMax Blood warmer set up

15

Loading the disposable

18

Connecting the disposable

20

Priming the disposable

21

Running the treatment

21

Stopping the treatment

22

Cleaning and disinfecting

23

AW7006 Rev A NOV2018 Program version: 1.XX

14 - Operating TherMax

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Operating TherMax - 15

Operating TherMax Blood warmer set up Before you start Read through each section before performing a procedure. To operate the TherMax blood warmer, the operator must first load the TherMax blood warmer disposable into the blood warmer, connect it to the Prismaflex set, and prime it. Follow the onscreen instructions on the PrisMax system to complete these steps. These steps are done in conjunction with the setup steps of the PrisMax system. The blood warmer disposable has a separate order number.

AW7006 Rev A NOV2018 Program version: 1.XX

16 - Operating TherMax WARNING! Risk of electric injury! In the event that any of the following has occurred, do not use the TherMax blood warmer until the appropriate corrective measures have been taken: • There is damage or visible wear to the cables or plugs. • There is damage to the housing or control panel. • The control panel is loose. • The blood warmer has been dropped or exposed to severe shock. • The blood warmer has been immersed or otherwise exposed to liquid. • Blood warmer alarm without knowing the cause. • The blood warmer is damaged or missing markings. WARNING! Risk of injury! Use only the TherMax blood warmer disposable with the TherMax blood warmer. The use of other disposables can result in inadequate performance of the blood warmer and patient injury or death. WARNING! Risk of infection! • Do not use the TherMax blood warmer disposable if the package is damaged or the end caps are not in place. • The blood warmer disposable is sterile and nonpyrogenic. To prevent contamination, use the blood warmer disposable as soon as it is removed from the package. Use aseptic technique when connecting the blood warmer disposable to the Prismaflex set. • When handling the blood warmer disposable, take adequate precautions to prevent exposure to infectious agents.

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Operating TherMax - 17

CAUTION! Position the control unit so the connection to AC (mains) power is accessible. NOTE! To avoid damage to the TherMax blood warmer disposable during installation, the blood warmer cover must be closed and locked prior to inserting the disposable. NOTE! The Prime cycle will not start unless the TherMax blood warmer disposable is installed correctly and completely. Ensure that the following is true: • The bag is fully installed. This can be confirmed by the PrisMax system's onscreen instructions. • The connections to the Prismaflex set return line are positioned properly. Instructions 1. Place the blood warmer in its Operating position (see figure "Operating position of the TherMax blood warmer", page 9). 2. Plug the blood warmer into the electrical outlet. The yellow Standby LED turns on when the device is in AC Connected Mode. CAUTION! Risk of injury! • When plugging in the TherMax blood warmer, be sure the power cord does not touch the scale hooks or fluid bags on the PrisMax system. Contact with the scales or bags during treatment can cause alarms; such as, Bag Weight alarm. • The power cord must not touch the patient and not affect or hinder staff.

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18 - Operating TherMax

Loading the disposable Before you start NOTE! For further information about the blood warmer disposable, consult its Instructions for Use (IFU). Instructions 1. To switch the TherMax blood warmer to On mode, press the Power button. WARNING! Risk of injury! If the red Service LED and the audible alarm on the monitor are activated automatically when the device turns on by pressing the Power button, do not use the device and contact the service department for repair. 2. Follow the onscreen instructions on the TherMax set-up screens of the PrisMax system. • Ensure the disposable lock on the front of the blood warmer is in the open position to the left. 3. Open the blood warmer disposable package. Do not use sharp items to open the package to avoid damage to the disposable. Remove the disposable from the package, keeping it flat.

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Operating TherMax - 19

4. Ensure the tab is facing to the left; insert the bag into the warmer. The PrisMax onscreen instructions will confirm when the disposable is fully installed. NOTE! Allow 2 seconds for the detection of the bag to be confirmed prior to adjustment. The front end of the blood warmer disposable is the end with the inlet and outlet connections.

Figure Loading the disposable 5. Be sure to lock the blood warmer disposable using the bag lock after correctly inserting the disposable into the blood warmer.

Figure Locking the disposable

AW7006 Rev A NOV2018 Program version: 1.XX