T-SEAL Instructions for Use ver 4 Dec 2015

INTRODUCTION

Every effort has been made to ensure that the information in this document is correct, but we make no guarantee to this effect and would appreciate any observations regarding the contents of this document. We may make improvements and alterations to the instrument and these changes will be incorporated in new issues of this publication when practicable. Print:

2

Uffe Tryckare, Upplands Väsby, 2015

INTRODUCTION

1

INTRODUCTION ... 4

2

SYMBOLS/MARKINGS DESCRIPTION ... 5

3

WARNINGS AND CAUTIONS ... 6

4

SPECIFICATIONS, PARTS AND ACCESSORIES ... 7 4.1

Specifications... 7

4.2

Parts ... 8

4.3

Accessories ... 9

4.4

User Interchangeable Parts ... 9

5

INSTALLATION ... 10 5.1

Unpacking and Inspection ... 10

5.2

Environmental Requirements ... 10

5.3

Installation Procedure ... 11

6

FUNCTIONAL DESCRIPTION ... 12 6.1

Description of Sealing ... 13

6.2

Description of Equipment... 13

6.3

Checking the Battery unit ... 14

7

OPERATING INSTRUCTIONS... 15 7.1

Preparation before Use ... 15

7.2

How to Seal Tubes ... 15

7.3

If the Sealer Doesn´t Start ... 16

7.4

LED indications ... 16

8

TROUBLESHOOTING ... 17 8.1

Battery Unit ... 17

8.2

Hand Unit... 18

9

CLEANING ... 19 9.1

Battery unit ... 19

9.2

Hand Unit... 20

10 WARRANTY AND SERVICE ... 21 10.1

Warranty ... 21

10.2

Service ... 21

10.3

Product Disposal ... 22

11

EMC TABLES ... 23

12 DECLARATION OF CONFORMITY ... 27

3

INTRODUCTION

1 INTRODUCTION This chapter contains a description and specifications of the T-SEAL MOBILE, a Portable Battery sealer from Terumo BCT. T-SEAL MOBILE is a fully automatic system for sealing PVC or EVA tubes, especially for tubes in blood pack systems. Following the sealing procedure the tube is easily pulled apart, due to the distinct sealing pattern, with no damage to the blood inside the tubes. Segments are formed by inserting the tubing into the slot at the front of the Hand unit to create a series of seals. T-SEAL MOBILE is comprised of a Hand unit and Battery unit which is connected to the Hand unit with the integrated cable. It is complete with inbuilt sealing head and ready to operate. The moving electrode front can be easily removed for cleaning. Different types or sizes of tubes can be used and the necessary sealing time is self-adjustable to suit the tubes that are being used. T-SEAL MOBILE works with radio frequency (RF) energy to generate heat for sealing. Users are requested to be cautious of potential electrical shocks or hazards while handling this sealer.

4

SYMBOLS/MARKINGS DESCRIPTION

2 SYMBOLS/MARKINGS DESCRIPTION On instrument and labels: This marking reflects compliance with the Council Directive 93/42/EEC on Medical Devices. Class II Battery charger: double insulation during charging.

Battery charger UL recognized component for Canada and U.S.A.

Symbol for “CATALOGUE NUMBER”.

Symbol for “WARNING”.

Follow instructions.

Symbol for “SERIAL NUMBER”.

Symbol for “DATE OF MANUFACTURE”.

Symbol for “Manufacturer”.

Storage conditions - Symbol for “TEMPERATURE”.

Storage conditions - Symbol for “RELATIVE HUMIDITY”.

Symbol for “Non-ionizing radiation”. Symbol (WEEE 2002/96/EC) - Do not dispose Product as municipal waste. Collect Product separately. Use collection and return systems available to you. Product brought to EU market after August 13th, 2005. Indicates information about the battery

5

WARNINGS AND CAUTIONS

3 WARNINGS AND CAUTIONS The general safety information in the manual is for operating personnel. Specific notes, cautions and warnings are found throughout the manual where applicable. Please read the Instructions For Use (IFU) carefully before use. NOTE

Identifies conditions that should be noted carefully.

CAUTION

Identifies conditions that could result in damage to the equipment.

WARNING

Identifies conditions that could result in personal injury or loss of life.

WARNINGS

T-SEAL MOBILE must be used in compliance with all specifications and operational procedures listed in this manual. Only trained personnel should use the T-SEAL MOBILE Cables and accessories, others than those specified, may result in increased emission or decreased immunity of the equipment or system. Only accessories designed for use with T-SEAL MOBILE should be used. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. If any of the components of T-SEAL MOBILE are exposed to blood, they must be cleaned with an appropriate disinfectant solution. The T-SEAL MOBILE generates RF energy during the sealing procedure and during movement of the electrode. T-SEAL MOBILE is not intended for use in an oxygen rich environment. T-SEAL MOBILE is not intended to be used with flammable anesthetics and not intended for use in conjunction with flammable agents.

CAUTION

ELECTROMAGNETIC INTERFERENCE REGULATIONS This equipment fulfils EN 60601-1-2:2007 Standards Electromagnetic Compatibility. Nevertheless this equipment uses radio-frequency (RF) energy to generate heat while the tube is being sealed and can affect other Medical Electrical Equipment. See table 1 for guidance. If installation and use is not performed in accordance with the IFU, it could cause interference with radio, television and instrument communications.

6

SPECIFICATIONS, PARTS AND ACCESSORIES

4 SPECIFICATIONS, PARTS AND ACCESSORIES 4.1 Specifications The table below lists the physical specifications. Terumo BCT code ...

T5460 T-SEAL MOBILE, a complete sealing system, which includes Battery unit, Hand unit, Charger and IFU.

Type of PVC (EVA) tube ...

Different types and sizes of tubes up to 6.2 mm (5.4 mm) outer diameter can be sealed due to a sophisticated sensing system, which automatically adapts sealing time.

Sealing capacity ...

Approximately 1500 seals/charge with PVC tubes up to 5 mm outer diameter at 20 °C (68 °F)

Continuous seal capacity ...

50

Mode of operation ...

Operation: 25%, Intermittent: 75%

Sealing time ...

0.4 up to 3 sec. depending on tubing

Intended Use ...

The T-SEAL MOBILE is an automatic system for sealing PVC and EVA tubes connected to blood bags included either in Blood Packs or in Apheresis Disposable Sets. The sealing can be performed when the donor is still connected to the Blood Pack or the Apheresis Disposable Set.

Input Power ...

Charger 110-240 V~ / 50/60 Hz Battery 29.6 VDC, 1.5 Ah, Li-Ion Mangan

Consumption ...

Charger: 30 W, Sealer: 150 W max

Fuses ...

Charger: T2 A 250 V (internal) Battery: 2 A (input) / 10 A (output) (internal)

RF Output ...

80 W max. / 50 Ω / 40.680 MHz

Size (W x H x D) Battery unit

165 x 106 x 32 mm (6.5 x 4.2 x 1.2 in)

Weight kg (Ib) ...

Battery unit: 0.68 kg (1.50 lb) Hand unit: 0.39 kg (0.86 lb)

Temperature...

Operating: 15 to 35 °C (60 - 95 °F) Storage: - 20 up to + 70 °C (- 4 up to 158 °F)

Humidity...

Operating: 10 up to 90% Rh (non condensing) Storage: 10 up to 90% Rh (non condensing)

Altitude ...

Operating: maximum 3000 meters (9842 feet)

In compliance with ...

EN 60601-1: 2006 General Reqirements for basic safety and essential performance EN 60601-1-2: 2007 Collateral standards for Electromagnetic Compatibility 7

SPECIFICATIONS, PARTS AND ACCESSORIES

Electrical safety ...

During charging Class II. During use: Internal power supply. The T-SEAL MOBILE is used in the same environment as medical equipment (hospitals and blood banks). It must be used by highly qualified personnel.

Manufacturer according to MDD ...

Conroy Medical AB: Valhallavaegen 1 S-194 63 Upplands Vaesby SWEDEN

Distributor ...

Terumo BCT Europe NV Ikaroslaan 41 1930 Zaventem Belgium

4.2 Parts T-SEAL MOBILE comprises the parts listed below:

Description

Hand unit

Battery unit

Battery charger without plug

Kit Primary Adaptors

Part No.

546900000

547900000

544900000

54410120

List of all cables and maximum lengths of cables, transducers and other electrical accessories with which the manufacturer claims compliance (cables, accessories used other than those listed may impact emission/immunity): Part

Reference

Specification

Battery charger without plug

8METSM003

Input: 100-240 V~/50-60 Hz/700 mA Output: 18VDC/1.66A

Kit Primary Adaptors

8METSM037

Euro mains connector UK mains connector Australia mains connector USA/Japan mains connector IEC 320 mains connector

8

SPECIFICATIONS, PARTS AND ACCESSORIES

4.3

Accessories

Description

Holster

Extension cord 1.2 m 5-pol

REF

8METSM004

8METSM005

4.4 User Interchangeable Parts

Description

Hand unit

Battery unit

Battery charger without plug

Kit Primary Adaptors

REF

8METSM001

8METSM002

8METSM003

8METSM037

9

INSTALLATION

5 INSTALLATION This chapter involves unpacking, temperature requirements and installation of the instrument.

5.1 Unpacking and Inspection 1. Visually inspect the cardboard box for damage. Report any damage immediately. 2. Lift the instrument out of the cardboard box and place it on a flat surface. The instrument is shipped in one cardboard box that includes: I. 1 Hand unit II. 1 Battery unit III. 1 Battery charger without plug IV. 1 IFU (English) V. 1 Kit Primary Adaptors 3. The above list is subject to change, refer to the packing list for accurate description of contents. If any parts are missing or if the parts are damaged, report it immediately. 4. Please keep all shipping and packaging materials, as they may be required for later transportation, at least during the warranty time.

5.2 Environmental Requirements To keep the instrument operating at its best, please observe the following: • The instrument should be placed on a flat surface free from dust, solvents and acidic vapor. • Use the instrument in an area free from vibration and with a room temperature of 15 35°C (60 - 95°F), and relative humidity 10% - 90%. • Handle the components with care in a clean environment.

10

INSTALLATION

5.3 Installation Procedure Preparing the sealer for use 1. Fit correct mains input plug to the Battery charger. 2. The changeable mains connector is available for European continent (standard), UK, USA/Canada and Australia/New Zealand and as IEC standard 320 C8. 3. Connect the charger (grey on connector) to the combined Hand unit/Battery charger cable connector. 4. Plug the charger into the mains. The charger can be connected to mains voltages between 100 and 240 V AC. 5. It takes about three hours to charge the Battery unit completely. When the charging level indication on the unit indicates 100% and the recharge indication flashes, the battery is fully charged. 6. Charge the battery to 100% before the first use. 7. Connect the Hand unit cable (grey at end of the cable) into the Battery unit connector. Make sure the connector snaps in secured position. 8. Perform a test seal on an empty or water filled tube to ensure proper operation. CAUTION

Only use the enclosed Battery charger for charging the Battery unit.

NOTE

Ensure that cable to handle is connected before use.

11

FUNCTIONAL DESCRIPTION

6 FUNCTIONAL DESCRIPTION This chapter describes how T-SEAL MOBILE works, where the connectors and the indications are placed on the unit and their functions. Front view of Battery unit

Charge level indicator

Recharge indicator

Battery test button

Hand unit/Battery charger cable connector

Rear view of Battery unit

View of Hand unit Seal indicator Tube slot Spring lock Trigger Electrode remove grip

12

FUNCTIONAL DESCRIPTION

View of Charger

Power indicator

6.1 Description of Sealing The tube to be sealed is placed in the slot of the Hand unit, between the electrodes. When the user presses the trigger on the Hand unit, the tube is pressed together and the sealing procedure will commence automatically. The radio frequency (RF) generator starts and the energy is transferred from the fixed electrode to the tube, which melts to a sterilized welding pattern. During the whole sealing process the orange Seal light on the front of the Hand unit is lit. When this light goes out, the sealing is complete and the trigger may be released. The intelligent sense control in the Hand unit detects, controls, and adjusts the necessary sealing activity to give the best sealing quality for the type of tubes that are being used. See section 7.4 for a description of the different LED indications on the Hand unit in case of problems.

6.2 Description of Equipment T-SEAL MOBILE consists of a Battery unit and a Hand unit. Below is a short description of each component. The Hand unit consists of an RF-generator with intelligent sense control, ergonomic handgrip with trigger, the moving electrode (which can be removed for cleaning) and the cable with connector. The Hand unit takes no power between sealing. The Battery unit consists of the environmental friendly LiIonMn battery pack, built-in optic charge level indicator and the combined charger/handle connector. The charge in the Battery unit is sufficient for approximately 1500 seals.

13

FUNCTIONAL DESCRIPTION

6.3 Checking the Battery unit To check the battery, just press the “TEST” button ❸ and the battery charge level indicator ❶ lights up. The capacity indication is in steps of twenty percent. The battery can be recharged at any time or at least when zero (red) remains. The zero level is also indicated on the handle with the red light and when seal is attempted, the seal function will be blocked. Recharging the battery: Connect the Battery charger to the Battery unit ❹ and the charger to the mains. The recharge indicator ❷ lights up. When the recharge indicator starts flashing, the battery is fully charged and the charge current is automatically turned off. The charge can be interrupted at any time without damage to the cells, but a full recharge will take less than three hours and is recommended.

❶ CAUTIONS

❷

❸

❹

Always check the seals when the battery capacity is low (20% or less). See section 7.2 for sealing pattern. Only use the enclosed Battery charger for charging battery in the Battery unit.

NOTES

To guarantee a long lifetime for the rechargeable battery, please observe the following requirements: Charge the battery at temperature between 5 and 35°C (40-95°F). If the indicator ❷ does not light up, check the connection to the charger and mains.

14

OPERATING INSTRUCTIONS

7 OPERATING INSTRUCTIONS This chapter describes the use of the instrument. WARNINGS

T-SEAL MOBILE uses radio frequency (RF) energy to generate heat for sealing. Users should be cautious of potential electrical shocks or hazards while handling this sealer. Always keep your fingers away from the electrodes in the slot. Never place any object other than the tube between the electrodes. This machine emits a low level of electromagnetic (non-ionizing) radiation while sealing. It should not be used near high frequency sensitive electronic equipment. See table 1 for guidance. Do not allow the Hand unit to come directly in contact with the donor. Do not perform a seal within 8 cm (3 in) of needle to preclude an RF burn at the needle entry point.

CAUTIONS

Inspect all parts of the instrument for defects before use. Check sealing pattern if Hand unit is dropped. Always check the seals when the battery capacity is low (20% or less).

7.1 Preparation before Use 1. Place the instrument on a flat surface near the working place or in the holster. 2. Check that there is sufficient battery capacity by pushing the “TEST” button. 3. Connect the Hand unit cable into the combined Hand unit/Battery charger cable connector. NOTE

Do not try to connect other sealers to the T-SEAL MOBILE Battery unit than the Terumo BCT T-SEAL MOBILE Hand unit.

7.2 How to Seal Tubes 1 Put the tube to be sealed down to the bottom of the slot in the Hand unit. 2 Check that the tube is placed between the electrodes in the slot. 3 Press the trigger to bring the two electrodes closer together until the light on top of the Hand unit comes on. The sealing time is normally 0.4 to 0.9 seconds; after a maximum of 3 seconds the RF is turned off. 4 When the light goes out, sealing is finished. Release the trigger and remove the tubing. 5 The center of the sealed pattern is very thin and pulling both sides will divide the tube into two pieces. 6 Check the tube for leakage. CAUTION

If you should make two or more seals, they should not be within 1 cm (0.4 in) of each other, otherwise the resulting pressure in the tube may cause microscopic cracks and holes in the seals.

CAUTIONS

In case of sealer malfunction (intermittent operation, poor seal quality, the sealing time seems too long or too short) contact your local 15

OPERATING INSTRUCTIONS

Terumo BCT representative for assistance. Periodically check whether the shape of the seal is symmetrical and there is a clear line in the middle of the seal (see picture below).

Good sealing pattern

Bad sealing pattern

The tube must be dry on the outside.

NOTES

Do not pull the tube and keep the trigger fully pressed down until the light goes out. If the trigger is released the sealing process stops.

7.3 If the Sealer Doesn´t Start The Sealer has several safety functions. Before sealing, these functions control and identify whether it is possible to seal the tube. The table below covers the common probable causes for problems and suggests some recommended actions. Probable cause

Recommended action

Leaky or wet tube

Dry the tube and try again

Tiny arcs between the electrodes

Dry the electrodes and try again

Wet or dirty electrodes

Clean and dry the electrodes

Low/no capacity in battery

Check/charge battery

Overheated (Hand unit LED red blinking)

Let the Hand unit cool down.

No seals

Check Battery unit and connection.

If the sealer still doesn’t start, see chapter 8 for further information

7.4 LED indications Battery unit • “Colored LEDs bar indicating battery status.” • “TEST”: button to check the battery. When pressed, the battery charge level indicator lights up. Refer to section 6.3. Hand unit • Indicator lights orange when RF-energy is being applied to the fixed electrode and turns off when sealing is completed. • Indicator flashes red at overheating, sealing function is blocked. • Indicator lights red one second in case of short circuit, sealing function is blocked. • Indicator lights red in case of battery low level, sealing function is blocked.

16

TROUBLESHOOTING

8 TROUBLESHOOTING Maintenance performed by the user is limited to changing Battery unit and Hand unit. The following information covers common problems and offers suggested solutions.

8.1 Battery Unit Problem

Probable cause

Recommended action

Charge level LEDs doesn’t

Battery too low voltage.

Charge battery for 3 hours.

light.

Fuse blown.

Contact your local Terumo BCT representative.

Other cause.

Contact your local Terumo BCT representative.

Charge Level LEDs do not

No voltage

Charge battery for 48 hours

light up during charge

Fuse blown.

Contact your local Terumo BCT representative.

Charge Level LEDs do not light up after 48 hours charge

Other cause.

Contact your local Terumo BCT representative.

Battery unit defective.

Change battery unit or contact your local Terumo BCT representative.

17

TROUBLESHOOTING

8.2 Hand Unit Problem The sealing doesn’t start.

Probable cause

Recommended action

Wet electrodes.

Dry the electrodes, see chapter 9.2.

Dirty electrodes.

Clean the electrodes, see chapter 9.2.

Wet tube.

Dry the tube and electrodes, try again.

Tiny arcs between the

Dry the electrodes and try again.

electrodes. The trigger does not “click"

Change Hand unit or contact your local Terumo

when it is fully squeezed.

BCT representative.

The trigger cannot fully engage when it is squeezed Hand unit defective. Battery not charged/low

Charge battery for 3 hours.

charge. Cable broken.

Contact your local Terumo BCT representative.

Other cause. Bad sealing.

Low battery charge.

Check the Battery unit charge level. Charge battery if needed.

Moving electrode doesn’t

Clean and oil electrode shaft,

move smoothly in handle.

see chapter 9.2.

Wet electrodes.

Dry the electrodes and try again.

Dirty electrodes.

Clean the electrodes, see chapter 9.2.

Moving electrode out of

See chapter 9.2, assembly of electrode.

position. Hand unit defective.

Change Hand unit or contact your local Terumo BCT representative.

Hard to divide tube after seal.

Other cause.

Contact your local Terumo BCT representative

Moving electrode doesn’t

Clean and oil electrode shaft, see chapter 9.2.

move smoothly in handle. Wet electrodes.

Dry the electrodes and try again.

Dirty electrodes.

Clean the electrodes, see chapter 9.2.

Rim on moving electrode damaged.

Contact your local Terumo BCT representative.

Other cause. Intermittent sealing.

Hand unit defective.

Change Hand unit or contact your local Terumo BCT representative.

Cable broken. Battery unit defective Hand unit LED still alight after seal trigger has been released. Hand unit LED doesn’t light. Hand unit LED flickers.

Hand unit defective

Change Hand unit or contact your local Terumo BCT representative.

Hand unit defective Cable broken Other cause

18

Contact your local Terumo BCT representative.

Contact your local Terumo BCT representative. Contact your local Terumo BCT representative.

CLEANING

9 CLEANING This chapter gives information on the cleaning (procedure, frequency) of the Battery and Hand units. The Sealer requires minimal maintenance for efficient operation. Follow the cleaning procedure below. WARNINGS

For you own safety always disconnect the Hand unit or charger from the Battery unit. Blood and blood products must be treated as potentially infectious at all times. In the event of blood spillages, appropriate protective clothing should be worn during cleanup procedures.

After removing residual biological material, surfaces which have been in contact with blood or components must be disinfected using a chemical agent considered to be “sterilizing” (isopropyl Alcohol 70%,...). Alternatively, a freshly prepared sodium hypochlorite (household bleach) solution may be used to disinfect surfaces. Diluted solutions of 1 part bleach to 10 parts water may be used. Regardless of the “sterilant” or disinfection solution used, remember to remove any residue to ensure that surfaces of the equipment are not subject to corrosion or discoloration. Discard all materials in contact with blood according to institutional policies regarding disposal of biohazardous materials. CAUTIONS

Do not disinfect or sterilize any part of the Sealer through autoclave, or with ethylene oxide gas. To do so will render the Sealer unusable and invalidate the warranty. Do not use chemical or abrasive cleaners such as acetone, ammonia or similar. Do not use sharp edged tools for cleaning, which could damage the finish of the units. Do not allow liquid to flow in the electronic part of the machine.

9.1 Battery unit Cleaning may be required as a result of spilled drops of blood or once per month. If spillage occurs, the unit must immediately be removed from service and cleaned completely before resuming use. Use a soft lint-free tissue, moistened with a mild detergent to clean the outside of the Battery unit. CAUTION

Do not, under any circumstances, submerge the Battery unit in any kind of liquid. This will damage the battery and void the warranty.

19

CLEANING

9.2 Hand Unit Clean once per week or more frequently, as required, if spillage of blood occurs. For cleaning the electrodes remove the moving electrode. Removal of moving electrode:

1.

Pull the blue trigger to “click” to release the moving electrode. Push spring lock forward. 2. First push inward, then pull out the electrode. Clean the handle and both electrodes with a soft lint free cloth moistened with mild detergent. Dry carefully and ensure that the electrodes are completely dry to prevent sparks. To clean the electrode shaft, use a dry cotton swab. After cleaning, inspect the electrodes for any mechanical damage or wear out. Do not use damaged part. For proper function, add a drip of light machine oil on electrode shaft after each cleaning! Assemble the parts in reverse order. Make sure the trigger and spring lock is in full forward position before electrode insertion. Insert the moving electrode ensuring that it is positioned so as to be parallel with the fixed electrode. Press the trigger twice and ensure that the moving electrode moves smoothly, is in position and not loose. CAUTION

The hand unit is not waterproof. Do not, under any circumstances, submerge the hand unit in any kind of liquid. Doing so will generate tiny electric discharges, cause the device to malfunction, and void the warranty.

NOTES

Some sealing tests are recommended before resuming use. Compare the pattern against picture in section 7.2. Do not push the trigger in after removing the electrode since this may block the locking mechanism.

20