PST 500 U Instructions for Use Ver 02

This page is intentionally blank.

Mobile operating table Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7–9 07318 Saalfeld Germany Phone: Fax:

+49 3671 586-0 +49 3671 586-41165

[email protected] www.trumpfmedical.com Trumpf Medizin Systeme GmbH + Co. KG is a company within the Hill-Rom Holdings Group. The manufacturer is hereinafter referred to as Trumpf Medizin Systeme. Technical Customer Service

Information about the document

The contact details for the current Technical Customer Service hubs in the individual countries are listed on the Internet at www.trumpfmedical.com. Original instruction manual Document number: Language ID: Version: Material number: Date of publication:

4990824 030 02 2071995 12-DEC-2019

This instruction manual is included in paper form in the scope of the product supply. This document applies to the following sales units: Product designation

Part number

Operating table PST 500 U Supporting documents

4080300

The operating table can be custom assembled using various Trumpf Medizin Systeme products. The instructions for use of all the products used then apply. Section 2.1 lists the compatible products along with their associated instructions for use.

4990824_030_02 – 2071995 – 12-DEC-2019

3

Mobile operating table This page is intentionally blank.

4

4990824_030_02 – 2071995 – 12-DEC-2019

Mobile operating table

Basic information After purchase, the product is handed over to the operator in an appropriate and professional manner. Handover is performed by someone authorized by the manufacturer and is documented using a handover protocol. Check the packaging on delivery for damage sustained during transport. If damage is noticed before unpacking, contact the Technical Customer Service. Before using the product, familiarize yourself with the settings options and how to operate the product. Observe the information notices on the product. About the instructions for use – This instructions for use contain important information about the safe and effective use of this product. – The instruction manual is part of the product and must be complied with. – Read the instruction manual carefully and fully before using the product. The instruction manual must be thoroughly understood. In the event of uncertainty or questions about the product, please contact the manufacturer. – The instruction manual must also be handed over in the event of a change of location or personnel. – The instruction manual must be kept where the product is used. – The instruction manual must be easily accessible in full to all users of the product at all times. – The figures in the instruction manual are highly simplified and are intended to provide a basic understanding. – Residual dangers that may occur while using the product are identified in the document with a signal word. The safety measures required and potential consequences of failing to take these are listed. A corresponding signal word provides information about the severity of the danger: Signal word

Meaning

DANGER

The signal word indicates a dangerous situation that will immediately lead to death or serious injury if no precautionary measures are taken.

WARNING

The signal word indicates a dangerous situation that may lead to death or serious injury if no precautionary measures are taken.

CAUTION

The signal word indicates a dangerous situation that may lead to moderate to slight injury if no precautionary measures are taken.

NOTICE

The signal word indicates a dangerous situation that may lead to material damage or damage to the environment if no precautionary measures are taken.

© Trumpf Medizin Systeme Reprinting, copying, or translating this document, in whole or in part, is forbidden without the express written permission of Trumpf Medizin Systeme. All rights under copyright law are expressly reserved by Trumpf Medizin Systeme.

4990824_030_02 – 2071995 – 12-DEC-2019

5

Mobile operating table This page is intentionally blank.

6

4990824_030_02 – 2071995 – 12-DEC-2019

Contents

Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

Usage specifications... 11 Normal use... 11 Intended purpose... 11 Contraindication... 12 Patient definition... 12 User definition... 12 Usage environment... 12 Ambient conditions for storage and transport... 13 Service life... 13

2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.8 2.8.1 2.8.2

Safety... 14 Combination with other products from Trumpf Medizin Systeme...14 Combination with products from other manufacturers... 15 Operator’s responsibility... 16 Use of high-frequency (HF) surgical equipment... 16 Use of defibrillators... 17 Malfunction caused by other devices... 17 What to do in the event of a malfunction... 17 Emergency operation of the operating table... 17 Reset... 18 Emergency unlocking of the parking brake... 19 Failure of the operating table's electrical functions... 19 Information notices... 20 Safety instructions... 20 Position and meaning... 20

3

Unpacking the operating table...23

4 4.1

Summary...26 Operating table and equipment... 26

5 5.1 5.2 5.2.1 5.2.2 5.3 5.4 5.5 5.6 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.7.6 5.7.7 5.7.8 5.7.9 5.7.10 5.8 5.9 5.9.1 5.9.2

Description... 27 Overview of the operating table... 27 Summary of control modules... 29 Column keypad... 29 Remote control... 30 Hook couplings... 32 Side rails... 33 Connections for cables... 34 Cladding protection... 34 Setting options... 35 Patient orientation... 35 Lift... 35 Tilt... 35 Trendelenburg... 36 Longitudinal slide... 36 Back section... 36 Leg section joint... 36 Level position... 37 Flex down / flex up... 37 Beach chair... 37 Automatic collision prevention... 38 Visual displays... 39 Column keypad... 39 Battery status display on the running gear...41

4990824_030_02 – 2071995 – 12-DEC-2019

7

Contents 5.9.3 5.9.4 5.10 5.11 5.11.1 5.11.2 5.11.3 5.11.4 5.11.5 5.11.6 5.11.7 5.11.8 5.11.9 5.12 5.13 5.14 5.15 5.16

Error code display on the running gear... 42 LED strip on the running gear (light messaging system)... 42 Sounds... 43 Maximum load capacity...44 Summary... 45 Operating tabletop with head section and leg section...46 Operating tabletop with seat section extension and leg section... 47 Operating tabletop with universal plate and head section... 47 Operating tabletop with Carbon 1200 tabletop section... 48 Operating tabletop with Carbon 600 tabletop section... 48 Operating tabletop with extension unit...49 Operating tabletop with shoulder chair...49 Side rails...50 Use with imaging systems...50 Driving modes... 51 Internal power supply (battery operation)... 51 External power supply (mains operation)... 51 Equipotential bonding... 52

6 6.1 6.2 6.2.1 6.2.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.9.1 6.9.2 6.10 6.10.1 6.10.2 6.10.3 6.10.4 6.10.5 6.10.6 6.10.7 6.10.8 6.10.9 6.10.10 6.10.11 6.10.12 6.11 6.12 6.13

Use...53 Safety instructions... 53 Selection of functions... 53 Operating mode... 54 Blocked keys... 54 Summary of how to use the operating table... 54 Charging the batteries (external power supply)... 55 Connecting / disconnecting the equipotential bonding cable... 56 Attach cladding protection... 56 Attaching the tabletop section to the operating tabletop... 57 Attaching accessories to the side rail... 57 Operating states... 58 Switch on the operating table... 58 Switching off the operating table... 58 Adjusting the operating table... 58 Safety instructions... 58 Patient orientation... 59 Lift... 59 Tilt...60 Trendelenburg...60 Longitudinal slide... 61 Back section... 62 Leg section joints together... 62 Leg section joints individually... 62 Level position... 63 Flex down / flex up... 63 Beach chair... 63 Activating the parking brake...64 Releasing the parking brake and moving the operating table...64 Switching the floor lighting on / off... 65

7 7.1 7.2 7.3 7.4 7.5 7.6

Cleaning and disinfection... 66 Introduction...66 Cleaning and disinfecting agents...66 Summary of cleaning and disinfection... 67 Preparing the operating table... 67 Cleaning the operating table... 68 Disinfecting the operating table... 72

8

4990824_030_02 – 2071995 – 12-DEC-2019

Contents 8

Troubleshooting...76

9

Maintenance... 78

10

Repair... 78

11

Disposal...79

12 12.1 12.2

Technical data...80 Device data... 80 Electromagnetic compatibility... 81

13 13.1

Product certification...84 European Union... 84

14 14.1 14.2

Accessories...85 Manufacturer Trumpf Medizin Systeme... 85 Third-party manufacturers... 90

15

Combinations of operating table and tabletop sections... 91

4990824_030_02 – 2071995 – 12-DEC-2019

9

Contents This page is intentionally blank.

10

4990824_030_02 – 2071995 – 12-DEC-2019

Usage specifications

1

Usage specifications

1.1

Normal use Normal use entails the following: – The positioning and task-specific transport of a patient before/ during/after surgery within a specifically designated operating theatre or surgical ward. The patient is positioned on the PST 500 operating table in accordance with general medical and hospital practice and doctrine, as described for example in the technical literature. – Cleaning the operating table surfaces and pads with suitable cleaning agents according to the directives of the medical facility. – Positioning of the operating table and the associated tabletop sections in a room intended for that purpose. – Regular maintenance of the operating table in accordance with the defined maintenance intervals by qualified service technicians. – Initial operation by the operator. – Repair and disposal of the operating table must be performed by qualified service technicians as required. Normal use includes sections 1.2, 1.4, 1.5, 1.6, and 1.7.

1.2

Intended purpose The medical device PST 500 is a mobile and configurable operating table, which is intended to be used in combination with specific tabletop sections, pads and accessories for patient positioning on the operating table during surgery, from the induction of anaesthesia through the actual surgery to recovery from anaesthesia. The tabletop sections and accessories must be intended for the combination with the operating table. The operating tabletop provides the possibility of X-raying the patient anterior - posterior outside the operating table column by using a conventional X-ray device. The operating table is also used for task-related patient transfer within the operating theatre. The mobile operating table is only intended for use in human medical applications.

4990824_030_02 – 2071995 – 12-DEC-2019

11

Usage specifications

1.3

Contraindication Transport of unrelated objects, devices, or materials on the PST 500 operating table is prohibited. The PST 500 operating table is not suitable for positioning of patients other than for the intended purpose. It is not permitted to exceed the approved maximum load capacity. No sharp-edged objects may be placed onto the pads. No adhesive films may be used on the pads. Damaged pads may no longer be used. Damaged mains power cables may no longer be used. The use of the operating table in combination with flammable mixtures of anaesthetic agents is prohibited. Changes by the operator to the medical product are prohibited. Extremities must not extend beyond the end of the operating table in a longitudinal direction. Exempt to this are accessories that are intended for this purpose.

1.4

Patient definition All patients up to a weight of 454 kg / 1000 lbs can be positioned on the PST 500 operating table. Depending on the tabletop sections used, the approved patient weight may be reduced to 135 kg / 297 lbs. The conditions for the various loads on the operating table are specified in section 5.11.

1.5

User definition The PST 500 operating table may be used and operated only by qualified staff. The training of the staff is performed by the manufacturer or other persons qualified by the manufacturer. The primary users are medically trained specialists. This includes, for example: – Anaesthetists – Surgical nursing staff – Surgeons of various specialisations The cleaning staff is included among the primary users. The cleaning staff only handles the mobile operating table during cleaning. No patient is present during cleaning. The cleaning staff has been trained to handle the mobile operating table.

1.6

Usage environment Temperature: +10 °C to +40 °C / 50 °F to 140 °F Air humidity: 20 % to 80 % Atmospheric pressure: 540 mbar to 1060 mbar / 54 kPa to 106 kPa Altitude: ≤ 5,000 m The operating table must not be used in potentially explosive atmospheres.

12

4990824_030_02 – 2071995 – 12-DEC-2019

Usage specifications

1.7

Ambient conditions for storage and transport The operating table must be stored and transported in the following conditions: Temperature:

-20 °C to +60 °C / -4°F to +140°F

Air humidity:

10 % to 95 %

Atmospheric pressure:

540 mbar to 1060 mbar / 54 kPa to 106 kPa

fragile contents

top

keep dry

1.8

Service life The service life with normal use is 10 years.

4990824_030_02 – 2071995 – 12-DEC-2019

13

Safety

2

Safety

2.1

Combination with other products from Trumpf Medizin Systeme Trumpf Medizin Systeme offers a wide variety of additional tabletop sections and accessories for the operating table. Not all products are available in all countries. More detailed information can be obtained from Trumpf Medizin Systeme's offices, which are located worldwide. Contact details are available online at www.trumpfmedical.com. Use of the operating table is permitted in combination with the following products from Trumpf Medizin Systeme. The products are described in separate instructions for use, which must be read carefully and in full. The document number of the instruction manual is listed in the column on the right. The combination of the operating table with the products listed has been tested by Trumpf Medizin Systeme and subjected to a declaration of conformity. Pads

Control modules

Product designation

Part number

Document number

Pad PST 500 H B U

2072451

4990839

Product designation

Part number

Document number

2070307

4990823

2070308

4990823

2072218

4990823

2072450

4990834

Cable remote control Remote Control PST 500 U Infra-red remote control Remote Control PST 500 W U Cable remote control with display Remote Control PST 500 D U Foot control Footswitch PST 500 Tabletop sections

The tabletop sections are designed by Trumpf Medizin Systeme for use in conjunction with the operating table to enable or support its intended purpose. The tabletop section is fastened to hook coupling points at the head or foot end of the operating tabletop and extends the positioning surface for the patient. Product designation

Part number

Document number

Manufacturer Trumpf Medizin Systeme

14

Table top segment Carbon1200 H V

1850989

Pad TTS Carbon one part B

1873466

Carbon 600 tabletop section H V

1739992

Pad TTS Carbon 600 H B

1770133

Single-part, lightweight leg section HV

2012543

Pad leg section, single-part, lightweight H B

1783522

4990053 4990052 4990123

4990824_030_02 – 2071995 – 12-DEC-2019

Safety

Product designation

Part number

Document number

Leg section four parts spreadable H VU

1853829

4990133

Pad leg section, four parts H B

1851579

Two-part leg section spreadable H U V

1739991

Pad leg section, two parts H B

1809671

Single-part leg section H U V

1739969

Pad leg section, single-part H B

1756392

Head section double joint H U V

1853828

Pad head section H B

1764878

Single-joint head section H U V

1769761

Pad head section H B

1764878

Seat section extension H V U

1909820

Pad seat section extension H B U

1909819

Universal section H V U

2072445

Universal plate pad H B

2072448

4990050

4990048 4990097 4990046 4990108 4990833

Third-party manufacturers Shoulder chair H

2009875

–

The possible combinations of the operating table and tabletop sections are shown in Section 15. Accessories

2.2

Trumpf Medizin Systeme accessories are intended for use in conjunction with the operating table to enable or support its intended purpose. The accessories are attached primarily to the side rail. The permitted accessories are listed in Section 14.

Combination with products from other manufacturers The operating table is not designed for use with products from other manufacturers (third-party products) and where no compatibility tests have been carried out by Trumpf Medizin Systeme. Trumpf Medizin Systeme does not, however, exclude the use of third-party products. If the operator intends to combine the operating table with third-party products, the operator is responsible for this combination. Trumpf Medizin Systeme accepts no responsibility for the combination of the operating table with third-party products. The guarantee/warranty for products from Trumpf Medizin Systeme may become void in the event of combination with third-party products.

4990824_030_02 – 2071995 – 12-DEC-2019

15

Safety

2.3

Operator’s responsibility The operator is the natural or legal person who operates the product himself for commercial or economic purposes or who leaves its operation to a third party. The operator bears the legal product responsibility for protecting personnel or third parties. Medical devices may only be operated and applied according to their intended purpose and the general rules of technology. Medical devices may only be operated or used by persons who have the training or knowledge required to do this. Instruction regarding the proper handling of the medical device is required. However, training is not required when the medical device is self-explanatory or instructions for a product with the same design have already been provided. Medical devices connected to each other as well as medical devices connected to accessories including software, or other objects, may only be operated and used when the specific combination is suitable with regard to its intended purpose and the safety of the patients, users, employees or third parties. Before the medical device is applied, the user must ensure that the product is operational and in an appropriate state and the user must further have read the instructions for use as well as other, attached, safety-relevant information and maintenance instructions. The instructions for use and the instructions provided with the medical device must be stored in a way that ensures that the user can access the information required for using the medical device at any time. The operator must report all serious incidents that occur in relation to the product to the manufacturer and the responsible authority.

2.4

Use of high-frequency (HF) surgical equipment The operating table is electrically conductive in accordance with the applicable regulations and standards. The operating table is suitable for the use of high-frequency surgical equipment. Electrically motorized operating table functions may be interrupted if high-frequency surgical devices are used simultaneously. There is a risk of burns to the patient when high-frequency surgical devices are used. The following safety measures must be followed in all cases: – Follow the instruction manual provided by the equipment manufacturer. – Position the patient only on dry towels or drapes. The patient must not come into contact with damp materials. – Position the patient on the operating table so that he or she is insulated from metal parts (operating table, accessories) and conductive pads or tubes.

16

4990824_030_02 – 2071995 – 12-DEC-2019

Safety

2.5

Use of defibrillators The operating table is electrically conductive in accordance with the applicable regulations and standards. The operating table is suitable for the use of defibrillators and defibrillator monitors. There is a risk of burns to the patient and the user when defibrillators are used. Staff are at risk of electric shock. The following safety measures must be followed in all cases: – Follow the instruction manual provided by the equipment manufacturer. – All accessories not specifically protected against defibrillation must be removed from the patient's body before defibrillation. – Prior to defibrillation, all personnel must move clear of the operating table.

2.6

Malfunction caused by other devices The medical or non-medical devices from other manufacturers may use the same frequency range as the operating table and infra-red remote control. If pieces of equipment with the same frequency range or a multiple of the frequency range is used in the same room, they can influence each other. This may therefore cause malfunctions of the operating table. Examples of potential sources of interference: – Electronic control gear (ECG) for fluorescent lamps – HF surgical devices – Wireless remote control for other devices (e.g. monitors) – Very bright indoor lighting

2.7

What to do in the event of a malfunction In the event of a malfunction, the operating table has the following functions available, depending on the problem that has occurred: – Emergency operation – Reset – Emergency unlocking of the parking brake Regardless of this, if the electrical function on the operating table fails, the operating table should be disconnected from the power supply and Technical Customer Service notified.

2.7.1

Emergency operation of the operating table Emergency mode on the operating table ensures the Trendelenburg function in the event of a malfunction. Emergency mode must be manually activated by the user using the column keypad. Operating the operating table in emergency mode: – The Trendelenburg function can be performed with the column keypad. The back plate and leg plate function can be carried out with the remote control, provided it has not malfunctioned. In emergency mode, none of the other functions are available. – Operation of the operating table with the infra-red remote control and foot control is not possible.

4990824_030_02 – 2071995 – 12-DEC-2019

17

Safety – Functions move at a lower speed and a continuous warning tone sounds. – The end positions are not monitored and collision monitoring is not active.

i20

2.7.2

Activate the emergency mode in the event of a malfunction: 1. Press the [i20] key on the column keypad for at least 10 seconds. A warning tone sounds and constantly repeats. Release the key once the warning tone stops. The display next to the [i20] key lights up. 2. Continue the ongoing operation through to the end. Attention: do not extend the operating table functions to the end position. 3. Notify the Technical Customer Service if the operating table develops a fault. The operating table must not continue to be used in emergency mode. The operating table can be returned to normal mode if the operating table is fully functional and there are no faults. To do this, switch the operating table off and back on again. Hold the off button down for at least 3 seconds.

Reset

38 i1

If the operating table reacts unexpectedly to a control, switch off the operating table and switch it back on. If you cannot even switch it off, press the reset button: 1. Push through the red circle on the information notice and press the [38] key below it. The operating table is switched off. Switch-off takes place regardless of whether the operating table is in battery- or mains-powered mode. 2. Switch the operating table back on via the column keypad [i1]. If an error code appears on the display on the running gear, or an error message appears in the display on the remote control, the operating table must not be used. 3. Regardless of whether a fault is present on the operating table or not, notify Technical Customer Service. The service engineer will check the operating table and replace the information notice. The operating table must not be switched off as normal with the reset button.

18

4990824_030_02 – 2071995 – 12-DEC-2019

Safety 2.7.3

Emergency unlocking of the parking brake If the parking brake on the operating table cannot be released with the remote control or column keypad, the emergency unlock function on the running gear can be used. The button is located at the head end of the running gear and is covered by an information notice. After an emergency unlock, Technical Customer Service must be notified.

39

2.7.4

Releasing the parking brake on the operating table with the emergency unlock: 1. Push through the red circle on the information notice and press the [39] key below it. The jack props in the wheels are retracted and the operating table is freely mobile. It is possible that the operating table can only continue to be used to a limited degree. 2. Notify the Technical Customer Service.

Failure of the operating table's electrical functions According to the current market state of the technological art, failure of the operating table cannot be completely ruled out, with the result that the electrical functions on the operating table are no longer available. In this rare case, stop using the operating table and notify Technical Customer Service.

4990824_030_02 – 2071995 – 12-DEC-2019

19

Safety

2.8

Information notices

2.8.1

Safety instructions – The information notices on the product provide information about residual dangers during use, or provide additional useful information. – The device label and all information notices must be present and be undamaged in the prescribed locations on the product. A damaged, illegible or missing device label / information notice must be replaced immediately. – Observe the information notices on the product. – The information notices must not be altered or removed.

2.8.2

Position and meaning

10 10 12

12

1 11 4

2

7

5

14

15

48

49

16

13

8 6

3

9

[50] Head end of the operating table [51] Foot end of the operating table No. Information notice

Meaning

[1]

Operating table name

[2]

Cladding protection name

[3]

Current operating table software version

[4]

Transportable mass (maximum weight of the operating table and patient)

20

4990824_030_02 – 2071995 – 12-DEC-2019