Thopaz Instructions for Use Dec 2016

Table of Contents Congratulations...6 1 Warnings and safety instructions...7 Safety instructions...9 2 Power supply and battery operation...10 Backup battery... 10 3 Charge battery... 11 Battery low... 11 Battery empty... 11 4 Description... 12 Introduction... 12 Intended use / indications... 12 Contraindications... 12 Intended user... 12 Intended patient population... 12 Important note... 12 5 Overview... 13 Definition of vacuum... 13 Main elements of Thopaz... 13 Operating elements... 14 Activating buttons... 14 Tubings... 15 Canisters... 17 6 Additional information... 18 Regulated pressure... 18 Safety pressure limit... 18 Tube flushing... 18 Safety chamber in canister... 18 Overflow protection / bacteria filter... 18 Leakage warning (does not correspond to «Leak in system» alarm)... 18 7 Installation... 19 Check initial delivery... 19 Initial startup...20 8 Preparation for use / operating instructions...22 Checks before use...22 Connect tubing...22 Snap in canister...23 Using 2 L canister...23 Switch Thopaz on... 24

4 | Table of Contents

EN Carry out functional check...25 Check therapy progress...26 Rounding Function...26 Graph mode...27 Zoom mode...28 Catheter check...28 Switching Thopaz off...29 Transfering data to PC with ThopEasy+...29 9 Replace canister...30 Canister with solidifier: activation of the solidification process...31 10 Changing pressure...32 Change pressure...32 Gravity mode...32 11 Changing settings...33 Change settings...33 Factory settings...34 Setting a changed parameter as standard...34 12 Taking a drainage sample...35 13 Troubleshooting and alarms...36 Pump not running...36 Description...36 Canister full...38 14 Warranty, maintenance and checks...39 Warranty...39 Maintenance...39 Routine Check...39 Instructions for FPT test...40 Safety Check... 41 15 General cleaning guidelines...42 General notes...42 Disposables...42 16 Accessories...44 17 Signs and symbols...45 18 Technical specifications...47 19 Disposal...48 20 Technical documentation...470 Appendix A...475 Appendix B... 477

Table of Contents

| 5

Congratulations With Thopaz, you have acquired an innovative digital chest drainage system that sets new standards in therapy and chest drainage management. Thopaz has an electronic measuring and monitoring system with optical and acoustic status indications. The device is a dry system, which means no fluids are necessary for operation. Important information regarding the course of therapy is indicated digitally and graphically on the display. Upon completion of therapy, it can be transferred to a PC. The handy size and extreme quietness of operation are pleasant for the patient as well as those in the vicinity.

6 | Congratulations

EN

1 Warnings and safety instructions WARNINGS Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTIONS Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. Safety related tip Indicating useful information about the safe use of the device. Thopaz is approved exclusively for the use as described in these instructions for use. Medela can only guarantee the safe functioning of the system when Thopaz is used in combination with the original Medela accessories (canisters, tubings, carrying strap, mains adapter, docking station – see chapter 16). Thopaz is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and can be used in the vicinity of other EMC-tested devices that fulfil the requirements as outlined in the IEC 60601-1-2 standard. Untested HF sources, radio networks or the like can impair the function of the device and should not be operated in the vicinity of Thopaz. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department. Please read and observe these warning and safety instructions before operation. These instructions for use must be kept with the device for later reference. Please note that these instructions for use are a general guide for the use of the product. Medical matters must be addressed by a physician. Medela considers itself only responsible for the effect on BASIC SAFETY, reliability and performance of Thopaz if it is used in accordance with the instructions for use. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. Subject to change.

Warnings and safety instructions

| 7

WARNINGS – Consult this manual prior to use. – Data transfer via USB is not allowed during therapy. – Before cleaning the device, pull the plug out of the fixed mains socket. – Do not use Thopaz in MRT (Magnetic Resonance Tomography). – Do not dry Thopaz with microwaves. – The device is not suitable for use while bathing, showering or in a hazardous explosive environment. – The pressure range to be set must be determined by a physician in accordance with the age and weight of the patient. – The secretions gathered must be monitored more regularly or frequently in accordance with the age and weight of the patient. – To ensure Thopaz can reduce the pressure, it is essential to wait 30 seconds between taking the sample from the sample port and unclamping the patient catheter (drain). – Do not use Thopaz if the drainage therapy indicates a pressure greater than Thopaz max. pressure range of -10 kPa. – Do not use Thopaz if the drainage therapy indicates a flow rate greater than Thopaz max. flow capacity of 5 l/min. – Do not use Thopaz if the drainage therapy indicates no pressure should be applied to the patient. – If a persistent air leak is shown, check the system is assembled correctly before taking further corrective actions. Ensure the system is air tight by clamping the catheter and observing the air leak decrease to zero. – The catheter/connector interface is a location where clotting may occur. We recommend regular monitoring of this interface and appropriate removal procedure in case of occurance. – Do not connect bilateral thoracic drains to one Thopaz unit. In such cases, the use of two Thopaz units is recommended. – The use of Thopaz for any other indication than intended is neither desired nor allowed. – The Thopaz system is not designed for retransfusion. – This product contains lithium-ion batteries which bear risk of fire, explosion and burns. Do not dissassemble, crash, heat above 100 °C (212 °F), incinerate or dispose of in fire. – For pediatric patients adapt pressure settings according to hospital guidelines. – Do not touch the patient and the docking contacts simultaneously.

8 | Warnings and safety instructions

EN CAUTIONS – No modification of all articles related to the Thopaz system is allowed. – Before connecting Thopaz to the power supply, please verify that the supply voltage corresponds to that given on the device specification plate. – Incorrect use can cause pain and injury to the patient. – Do not use sterile accessories when the sterile packaging is damaged. – For patients for whom a breakdown of the device can lead to a critical situation a replacement device must always be available. Safety related tip – A visual inspection of the housing and power cord must be carried out before each use. – Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate. Safety instructions – Thopaz is a medical device that requires special safety measures in regard to EMC. It must be installed and put into operation in accordance with the attached EMC information in chapter 22. – Portable and mobile RF communications equipment can affect medical devices. – In each of the following cases, Thopaz must not be used and it must be repaired by Customer Services: – if the power cord or the plug are damaged. – if the device is not functioning according to manuacturer. – if the device is damaged. – if the device shows safety defects. – Keep the power supply cord away from hot surfaces. – The mains plug and the on / off switch must not come into contact with moisture. Never pull the mains plug out of the fixed mains socket by pulling on the power supply cord! – Thopaz must stand upright during use. – Separation from the mains is only assured through the disconnection of the mains adapter and fixed socket connection. – Never use the device at high room temperatures, while bathing or showering, if you are very tired or in an environment where there is a risk of explosion. – Never place Thopaz in water or other liquids. – When using single use, sterile products, please note that they are not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and / or

Warnings and safety instructions

| 9

biological characteristics. Reuse could cause cross contamination. – Contact your local Medela customer service representative for assistance with product operations. – Wear gloves for all operations. – The patient should be regularly monitored according to internal hospital guidelines. – A replacement device must always be available for patients for whom a breakdown of the device can lead to a critical situation. These instructions for use must be kept for later reference.

2 Power supply and battery operation WARNINGS This product contains lithium-ion batteries which bear risk of fire, explosion and burns. Do not dissassemble, crash, heat above 100 °C (212 °F), incinerate or dispose of in fire. Thopaz can be operated from the mains power supply 077.0148, from the docking station 079.0037 or with the integrated lithium-ion battery. Before using the docking station, read first the docking station instructions 200.1554. The battery is charged on mains operation or on docking station. The battery duration is dependent on the run-time of Thopaz. This is influenced by the extent of parenchymal leakage and the set pressure. Thopaz does not run continuously but only switches on when the actual and nominal negative pressure differ. During continuous operation, Medela guarantees a minimum run-time of 4 hours in battery operation after the device has been fully charged. In practical operation the real battery run time results in > 10 hours. If Thopaz is not used very often, the battery must be charged approximately every 6 months to ensure optimum functioning.

Safety related tip Backup battery If an internal defect occurs (broken cable, battery defective), an acoustic warning signal is sounded for at least 3 minutes. Power is supplied by the backup battery. Replace Thopaz immediately.

10 | Power supply and battery operation

EN

3 Charge battery Plug the Thopaz Power supply into a wall outlet and open the small protection cover to access the DC socket. Plug the coaxial power supply into the DC socket. Moving bars on the battery display will indicate charging is occurring [ ].

Battery low Approximately 30 minutes before the battery is fully empty an acoustic signal sounds and the ] starts to blink. The acoustic signal can be muted but the battery symbol battery symbol [ continues to blink until the battery is empty. The set pressure is maintained but the battery should be recharged as soon as possible.

to acknowledge an acoustic alarm (see chapter 13) Press simultaneously, then follow the instructions on the display Battery empty The battery symbol will blink with an acoustic sound for 10 minutes prior to the battery fully discharging, unless the pump is switched off earlier. The acoustic sound cannot be muted during the 10 minutes. If Thopaz is not connected to a power source the system will switch off automatically after 10 minutes. The negative pressure is not maintained after the system turns off.

1. Battery empty (sign is blinking)

3. Battery is being charged (moving bars)

2. Battery almost empty

4. Battery is fully charged

Charge battery

| 11

Intended use

4 Description Introduction Thopaz is a high-quality digital chest drainage system. The compact system provides regulated negative pressure close to the patient’s chest. It monitors the air leak and only applies the suction required to maintain the negative pressure prescribed and set by the managing physician. The digital display provides objective data in real time as well as a 24-hour historical graph of the air leak, which allows easy tracking of the therapy progress. The system combines easy handling and cleaning with safety features to ensure optimal operation. Intended use / indications Thopaz is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz is intended for use on patients in appropriate care settings. Contraindications There are no known contraindications for the Thopaz digital chest drainage system. Intended user Thopaz should only be operated by trained users. These persons must not be hard of hearing or deaf and must have adequate visual faculty. Intended patient population Thopaz is intended to be used on patients only exhibiting conditions as described in the indications for use. Important note Compliance with proper surgical procedures and techniques is the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience.

12 | Description

EN

5 Overview Definition of vacuum By the application of medical aspiration devices, vacuum is normally given as the difference (in absolute figures) between absolute pressure and atmospheric pressure or as negative values in Kilopascal (kPa). In this document, the indication of -10 kPa for example always refers to a pressure range in kPa below atmospheric ambient pressure (according to EN ISO 10079:1999). Main elements of Thopaz

Tubing guide Suction port Display Release button

Canister (ill. 0.3 l) USB port Mains adapter port

Carrying handle

Vacuum port with seal Bed holder Standard rail holder

Specification plate Docking contacts Overview

| 13

Operating elements

Run/Standby indicator

Battery charging status

Switch to Standby mode by pressing «Standby» for longer than 3 seconds. Therapy number

Power on/off to acknowledge an acoustic alarm (see chapter 13) Press simultaneously, then follow the instructions on the display Press simultaneously to change pressure and settings (see chapter 10, 11)

Activating buttons Press the buttons briefly to activate. Exception:  T he «Standby» button must be pressed for longer than 3 seconds to prevent an unintended interruption of the therapy.

14 | Overview

EN

accessories

Tubings

Normal/small/large/single/double connector Material: PVC (medical grade) sterile, twofold packaging Length: 1.5 m Patient connector single / double

Thopaz tubing double 079.0022

Sample port Tube clamp

Connection to canister Patient tube Overflow protection/bacteria filter Connection to pump

Measuring tube

Patient tube inner diameter

Connector outside diameter 2 Connector outside diameter 1

079.0025/26: Patient tube inner diameter: 5.5 mm Connector outside diameter 1: 9.5 mm Connector outside diameter 2: 16 mm 079.0021/22: Patient tube inner diameter: 5.0 mm Connector outside diameter 1: 6.4 mm Connector outside diameter 2: 16 mm 079.0023/24: Patient tube inner diameter: 5.0 mm Connector outside diameter 1: 4.0 mm Connector outside diameter 2: 11.0 mm

Overview

| 15

Thopaz tubing single, large connector 079.0025

Thopaz tubing double, large connector 079.0026

Thopaz tubing single 079.0021

Thopaz tubing double 079.0022

Thopaz tubing single, small connector 079.0023

Thopaz tubing double, small connector 079.0024

Safety related tip Medela recommends to use the biggest possible connector size compatible for the catheter.

16 | Overview

EN Canisters

With/without solidifier 0.3 l/0.8 l/2 l Material: Polypropylene, sterile Reading accuracy: +/– 2.5 % (in upright position) Solidifier: 0.3 l = 12 g / 0.8 l = 28 g / 2 l = 2 x 30 g Simethicone capsule: prevents foaming (0.3 l = 720 mg / 0.8 l = 1440 mg / 2 l = 1440 mg Simethicone) Graduation Overflow protection/bacteria filter Pressure relief valve Sealing cap Label for canister detection Safety chamber Closed chamber with solidifier Secrection chamber Simethicone capsule Thopaz canister 0.8 l, antifoaming

079.0016

Thopaz canister 0.8 l with solidifier, antifoaming 079.0017

Thopaz canister 0.3 l, antifoaming 079.0011 Thopaz canister 0.3 l with solidifier, antifoaming 079.0012

Thopaz canister 2 l, antifoaming 079.0018 Thopaz canister 2 l with solidifier, antifoaming 079.0019

Safety related tip Use sample port of tubing to drain a sample. Therefore refer to chapter 12 – Taking a drainage sample. The simethicone capsule requires 60 min of submersion for full effect. Overview

| 17

6 Additional information Regulated pressure The pressure is regularly checked and adjusted by Thopaz. The set pressure corresponds to the pressure of the entire system including the patient. Safety pressure limit The adjustable pressure range for Thopaz is -0,1 to -10 kPa (-100 mbar, -75 mmHg). If pressure value is greater than -7 kPa (-70 mbar, -53 mmHg) are set, the following warning appears in the display: too high pressure can cause pain and injuries to the patient. This warning must be acknowledged with «OK» before the pressure can be increased further. Tube flushing Flushing of the tubing occurs approximately every 5 minutes or when Thopaz detects a siphon and prevents clogging of the patient tubing. Safety chamber in canister For appropriate, safe operation Thopaz must be in an upright position. If Thopaz tips, the special construction of the safety chamber in the upper region of the canister protects the hydrophilic filter from premature clogging. The pressure is maintained. Important: immediately set Thopaz upright again. This feature is disabled if the maximum filling capacity of the canister is exceeded. Overflow protection / bacteria filter A hydrophilic overflow protection / bacteria filter in the canister as well as in the tube sets (in the connector to Thopaz) protects Thopaz from the entry of fluids and protects the environment from contamination. Leakage warning (does not correspond to «Leak in system» alarm) A significant and sustained increase in the flow rate indicates that there is a leakage in the system or an irregularity in the course of therapy. This function can be switched on as required - see chapter 11.

18 | Additional information

EN

accessories

7 Installation 7.1 Check initial delivery

Check the delivery package of Thopaz for completeness and general condition. Thopaz™ 079.0000 with Instructions for use 200.0685 079.0002 with Instructions for use 200.0686 079.0003 with Instructions for use 200.2004 Thopaz wall mains adapter coaxial DC plug 077.0148

Thopaz CD 079.0035

Instructions for use 200.0685 (for 079.0000) 200.0686 (for 079.0002) 200.2004 (for 079.0003)

Installation

| 19

7.2

Initial startup WARNINGS For use only after instruction by medically trained and qualified persons who have been adequately trained in the use of Thopaz. CAUTIONS Before the first application in accordance with the intended use, an inspection according to IEC 62353 (see Appendix B) is recommended.

before use 7.2a Checks – Check Thopaz system before use for damage of the power cord or plug, obvious device damage or safety defects and proper functioning of the device. – Check for completeness and general condition of Thopaz delivery package.

startup 7.2b Initial procedure

1.

1.1 Select plug. 1.2 Attach plug to the mains 077.0148. adapter

2.

2.1 Connect Thopaz to mains by mains adapter 077.0148 or by docking station 079.0037.

Important: Do not yet connect the patient to the system. 3.

20 | Installation

3.1 Charge for approximately 3 hours or until the [ ] symbol appears in the display. ] to switch 3.2 Press [ Thopaz on. A selftest starts.

EN 4.

4.1 Select language. 4.2 Confirm with «OK». 4.3 Follow instructions on display.

5.

] to switch 5.1 Press [ Thopaz off.

6.

6.1 Disconnect Thopaz from the fixed mains socket by pulling on the plug housing. Do not pull on the cable or the bend protection.

7. Thopaz is ready for preparation for use.

Installation

| 21

8 Preparation for use / operating instructions WARNINGS For use only after instruction by medically trained and qualified persons who have been adequately trained in the use of Thopaz. Wear gloves for all operations. «Pressure» generally implies «negative pressure». CAUTIONS – Sterile accessories must be checked on the integrity of the packaging before use. – Non sterile and reusable accessories must be clean and disinfected according to the Medela cleaning guide 200.2391 – Do not switch Thopaz on before charging the battery first. before use 8.1 Checks – Check Thopaz system before use for damage of the power cord or plug, device damage or safety defects and proper functioning of the device. – Check that the seal is correctly placed in the vacuum port of Thopaz. If you do not know where the vacuum port is placed please refer to Chapter 5 – Overview. – Check for completeness and general condition of the Thopaz delivery package. – Make sure that the rechargeable battery is recharged in case Thopaz is operated in battery mode. – Check all accessories prior to use: – canister for cracks, brittle and flawed spots. – tubing for cracks, brittle areas and that connectors are firmly attached. Replace if necessary.

8.2 Connect tubing

1.

1.1 Open external packaging.

2.

2.1 Insert the smaller of the two connectors (connection to pump) horizontally in the direction of the arrow.

22 | Preparation for use / operating instructions