TruSystem 7500 Instructions for Use Ver 08

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TruSystem 7500 Manufacturer

Baxter Medical Systems GmbH + Co. KG Carl-Zeiss-Straße 7–9 07318 Saalfeld Germany Phone: Fax:

+49 3671 586–0 +49 3671 586–41165

surgical@hillrom.com hillrom.com Baxter Medical Systems GmbH + Co. KG is a Baxter International Inc. company. The manufacturer is hereinafter referred to as Baxter. 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.hillrom.com. Original instructions for use Document number: Language ID: Version: Part number: Date of publication:

7990010 030 08 2078288 2023-01-19

These instructions for use are 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 TruSystem 7500 Supporting documents

The following additional documents are available online under ois.hillrom.com/ois: Product designation

Document number

Compatibility matrix

7990090

Radio Information

7990101

SVHC list (Substances of Very High Concern)

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4091000

–

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TruSystem 7500

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 instructions for use are part of the product and must be complied with. – Read the instructions for use carefully and fully before using the product. The instructions for use must be thoroughly understood. In the event of uncertainty or questions about the product, please contact the manufacturer. – The instructions for use must also be handed over in the event of a change of location or personnel. – The instructions for use must be kept where the product is used. – The instructions for use must be easily accessible in full to all users of the product at all times. – The figures in the instructions for use 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.

© Baxter Medical Systems GmbH + Co. KG Reprinting, copying, or translating this document, in whole or in part, is forbidden without the express written permission of Baxter. All rights under copyright law are expressly reserved by Baxter.

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Contents

Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Usage specifications... 9 Intended purpose... 9 Contraindication... 9 Patient definition... 9 User definition...10 Usage environment...10 Ambient conditions for storage and transport...10 Service life... 11

2 2.1 2.2 2.3 2.4 2.5 2.6 2.7

Safety... 11 Combination with other products from Baxter... 11 Combination with products from other manufacturers... 12 Operator’s responsibility... 12 Use of high-frequency (HF) surgical equipment... 13 Use of defibrillators... 13 Malfunction caused by other devices... 13 Information notices...14

3

Summary... 15

4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.2.10 4.2.11 4.2.12 4.2.13 4.2.14 4.2.15 4.2.16 4.3

Description... 16 Summary of control modules... 16 Setting options for the operating table... 17 Patient orientation... 17 Lift... 17 Tilt... 17 Trendelenburg... 18 Longitudinal slide... 18 Transverse slide... 18 Back section... 18 Back section joints... 19 Leg section joints... 19 Joints of the upper back section... 19 Level position... 20 Flex down / flex up... 20 CPR position... 21 Brake... 21 Localize wireless remote control... 21 Floor lighting (EndoLight)... 21 Software settings... 22

5 5.1 5.2 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 5.4 5.5

Use...23 Safety instructions... 23 Installation of the fixed-installation operating table column... 24 Unpacking the operating table... 24 Individual shipment of mobile operating table column... 24 Mobile operating table column with operating tabletop and transporter... 25 Transporter with operating tabletop... 26 Mobile operating table column with operating tabletop... 27 Single shipment transporter... 28 Operating tabletop individual shipment... 29 Individual shipment of the fixed-installation operating table column... 29 Individual shipment of cleaning shuttle... 29 Summary of how to use the operating table... 30 Decommissioning... 30

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Contents 6 6.1 6.2 6.3 6.4 6.5

Cleaning and disinfection... 31 Cleaning and disinfecting agents... 31 Summary of cleaning and disinfection... 32 Preparing the operating table... 33 Cleaning and subsequently disinfecting the operating tabletop... 33 Clean and then disinfect the operating table column... 38

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Maintenance... 39

8

Repair... 40

9

Disposal... 40

10 10.1 10.2

Technical data... 41 SVHC (Substance of very high concern)... 41 Electromagnetic compatibility... 41

11 11.1 11.2 11.3 11.4

Product certification... 45 European Union... 45 Ukraine... 45 Serbia... 45 EAEU... 45

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Radio license... 45

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Usage specifications

1

Usage specifications

1.1

Intended purpose The operating table is intended for the following use: – Patient positioning during surgical interventions including initiation and ending of anesthesia – Application-related transfer of patients within operating rooms

1.2

Contraindication Do not transport objects, devices, or materials on the operating table and its accessories. The products described in these instructions for use are for human medical use only. Hazard to the patient. Changes to the medical product are prohibited. The manufacturer is not liable for changes made to the operating tabletop. Risk of personal injury and damage to goods when the permitted loads are exceeded. Do not exceed the permitted load capacity for the operating table. If the permissible load is exceeded, the mobile operating table may tip over and cause serious injuries to the patient or staff. In general, overloading the operating table can lead to a failure of electrical functions and cause material damage to mechanical parts. Hazard to the patient. The patient must only be positioned on the operating tabletop while lying down. Extremities must not extend beyond the end of the operating table in a longitudinal direction. Improper loading may damage the operating tabletop or cause the mobile operating table to tip over. When the operating tabletop is moved in a longitudinal direction, the patient must not climb onto or off the operating table over the side of the extended operating tabletop. Patients may only get on or off in the area of the support column. Do not sit, crouch or kneel on the end of the tabletop.

1.3

Patient definition The surgeon basically decides whether the operating table (mostly depending on the tabletop) is positioned correctly for performing surgery on the patient. However, there are some restrictions with regard to the body weight and size of patients. The various patient groups that can be placed on the operating tabletop (in combination with the operating table column) are listed in the instructions for use.

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Usage specifications

1.4

User definition The TruSystem 7500 operating table is to be operated by trained personnel only. Personnel training is carried out by the manufacturer, or by other persons accredited by the manufacturer. The primary users are medically trained, specialized personnel. These include, for example: – Anesthetists – Operating room nurses – Surgeons in various specialized fields Cleaning staff are also included among the primary users. Cleaning personnel operate the mobile operating table, but only during cleaning. No patients are present during cleaning. The cleaning staff are trained to operate the operating table.

1.5

Usage environment Temperature: Air humidity: Atmospheric pressure:

+10°C to +40°C/50 °F to 104 °F 20% to 80% 70 kPa to 106 kPa / 10 psi to 15 psi

The operating table must not be used in potentially explosive atmospheres.

1.6

Ambient conditions for storage and transport Temperature:

-15 °C to 55 °C / 5 °F to 131 °F

Air humidity:

10 % to 95 %

Atmospheric pressure:

70 kPa to 106 kPa / 10 psi to 15 psi

Fragile contents

Top

Keep dry

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Safety

do not stack

Hazardous goods

Transport in a freight airplane (passenger airplane prohibited)

1.7

Service life With normal use, the service life is 10 years.

2

Safety

2.1

Combination with other products from Baxter Use of the operating table is permitted with other products from Baxter. The approved products are listed in the compatibility matrix 1). Baxter offers a number of products that can be combined with the operating table. Not all products are available in all countries. Detailed information can be obtained from the relevant representative offices of Baxter, which are represented worldwide. Contact details are available online at www.hillrom.com.

1 ) Document number 7990090

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Safety

2.2

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

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. The medical device may only be operated and applied according to its intended purpose and the general rules of technology. Medical devices may only be 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 user and/or patient must report any serious incidents related to the use of the medical device to the manufacturer and the relevant authorities of the member state of which the user and/or the patient is a resident.

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Safety

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 instructions for use provided by the equipment manufacturer. – 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.

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 instructions for use 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 Moreover, malfunctions will result while using the operating table in conjunction with the infrared remote control in the event that the TruSystem 7500 operating table is located in the same room as a TruSystem 7000 or PST500 operating table that is switched on.

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Safety

2.7

Information notices The information notices on the components are indicated in the instructions for use of the individual components. The device label must be present and undamaged in the prescribed locations on the product. A damaged, illegible or missing device label must be replaced immediately. The device label may not be altered or removed. No. Information notice Meaning [1]

System device label for the TruSystem 7500 operating table (on the operating table column) Manufacturer

1

Unique device identification (UDI), comprising: – Data Matrix Code – (01) Global Trade Item Number (GTIN) – (11) Date of manufacture (Year Month Day) – (21) Serial number – (240) Part number Baxter part number Serial number Medical product The device conforms to Regulation 2017/745/EU concerning medical devices. Caution! Follow the warnings in the instructions for use! All-round splash protection The product must be disposed of at a suitable disposal facility for the recycling of electrical and electronic devices in accordance with the requirements of Directive WEEE II 2012/19/EU and country-specific regulations. Device has an internal power supply Degree of protection against electric shock: Type B applied part Date of manufacture

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Summary

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Summary The operating tables are individually configurable and consist of an operating table column, an operating tabletop and a transporter, with which the operating tabletop or operating table column can be transported. The operating table can be combined with other Baxter products. The combination options are indicated in the instructions for use of the individual components.

6

5 2 6 7 5

3

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TruSystem 7500 operating table: [2] Operating tabletop The operating tabletops are single- or two-part operating tabletops which can be adapted to the required patient position with the use of various functions. [3] Operating table column Fixed-installation operating table column: The operating table column is permanently installed in the operating room and cannot be moved to another location. Mobile operating table column: The operating table column can be moved with the transporter. The setup location of the operating table column is flexible. [4] Transporter (Shuttle) Combinations: [5] Tabletop section 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. [6] Side rail accessories [7] Remote control

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Description

4

Description

4.1

Summary of control modules The operating table is operated as standard with the remote control. The remote control is absolutely necessary for using the operating table to its full potential. If the remote control is temporarily unavailable, due to reasons such as a flat battery, the basic functions of the operating table can still be executed using the column keypad. Other optional control modules are available from Baxter. The operating table can be adjusted using the following control modules: – Column keypad – Remote control – Footswitch – Sensor Control FloatLine cable operating unit (only for OR table top Carbon FloatLine) The range of functions of the different control units varies. The commands of the individual control units are listed in the following sequence: 1. Column keypad 2. Cable remote control 3. Sensor Control FloatLine cable operating unit (only OR table top Carbon FloatLine) 4. Radio remote control 5. Footswitch 6. IR remote control The simultaneous activation of keys on various control units results in audible error messages or in the execution of table functions in order of priority. Press the respective function key on the control unit until the desired position has been reached. The function stops in the following situations: – The key is released. For further adjustment, press the function key again. – The level position has been reached. This option must be configured in the operating table (default setting). The automatic stop at the level position is indicated by an audible signal. For any further adjustment, briefly release the function key and then press it again. – The intermediate stop is reached. You will hear an audible signal when the intermediate stop has been reached. For any further adjustment, briefly release the function key and then press it again. – The end position has been reached. The automatic stop in the end position is indicated by an audible signal.

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Description

4.2

Setting options for the operating table The available functions on the operating table are dependent on the configuration and combination of the operating table. Take note of the operating instructions of the operating tabletop and the operating table column used.

4.2.1

Patient orientation For the motor functions on the operating table, the operating table must be aware of the patient's current head position on it. Only if the indicator on the column keypad matches the orientation of the patient on the operating table will the operating table's functions be carried out on the correct side. The direction of the operating tabletop is automatically recognized by the operating table column after transfer from a shuttle to the operating table column. The head position of the patient corresponds to the relevant indicator when the patient lies with the head on the head side of the operating tabletop. The adjustment ranges for the functions may be different with normal and inverted patient orientations, since the function is carried out based on the patient's position. For example, the leg section joints assume the function of the back section in the inverted patient position. Commands are given using the keys for the back section. Normal patient orientation (default setting): The patient lies with their head at the head end of the operating tabletop. After the operating table has been switched on, normal patient orientation is always automatically activated. Inverted patient orientation: The patient lies with their head at the foot end of the operating tabletop. The patient orientation must be inverted. The inverted patient orientation remains activated only for as long as the operating table is switched on, or until the patient orientation is switched back to normal.

4.2.2

Lift The operating tabletop is moved electrically upward [A] or downward [B]. A

4.2.3

B

Tilt The operating tabletop is tilted around its longitudinal axis to the left [A] or right [B]. The side specification is based on the user's perspective when standing at the head end of the patient.

A

B

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Description 4.2.4

Trendelenburg The operating tabletop is moved electrically around its transverse axis. With the reverse Trendelenburg function [A], the operating tabletop is moved with the foot end downward. With the Trendelenburg function [B], the operating tabletop is moved with the head end downward.

A

B

4.2.5

Longitudinal slide Manually adjustable: The operating tabletop is manually moved towards the foot end [A] or head end [B] of the patient. A

Electrically adjustable: The operating tabletop is moved electrically towards the foot end [A] or head end [B] of the patient. B

4.2.6

Transverse slide

A

4.2.7

B

The operating tabletop is moved electrically towards the left side [A] or right side [B] of the patient. The transverse slide function can only be selected with the remote control.

Back section The back section is electrically moved upwards [A] or downwards [B]. A

B

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Description 4.2.8

Back section joints

A

B

4.2.9

Leg section joints Manually adjustable: The joints on the seat section can be individually manually adjusted upwards [A] or downwards [B]. The position of the joint for the seat section can be seen from the line markings on the gears. The joint is on the same plane as the seat section when the gearing line markings from both parts match up.

A

Electrically adjustable: The joints are inclined electrically upward [A] or downward [B]. The joints can only be moved together with the column keypad. With the remote control, when the normal patient orientation is selected, the right and left joints can be moved independently of each other. The default setting on the remote control is for the joints to be adjusted together. The joints cannot be adjusted individually if a single-part tabletop section is attached to both joints. The single-part tabletop section is automatically recognized by the operating table and the functions of the individual joints are locked.

B

4.2.10

The joints are inclined electrically upward [A] or downward [B]. The joints can only be moved together with the column keypad. With the remote control, when the inverted patient orientation is selected, the right and left joints can be moved independently of each other. The default setting on the remote control is for the joints to be adjusted together. The joints cannot be adjusted individually if a single-part tabletop section is attached to both joints. The single-part tabletop section is automatically recognized by the operating table and the functions of the individual joints are locked.

Joints of the upper back section

A

B

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Manually adjustable: The rails on the back plate can be individually manually adjusted upwards [A] or downwards [B]. The position of the joint for the back plate can be seen from the line markings on the gears. The joint is on the same plane as the back section when the gearing line markings from both parts match up. Electrically adjustable: The joints on the back section are electrically tilted upwards [A] or downwards [B]. The joints can only be moved together with the column keypad. In the inverted patient position, the back plate takes over the function of the seat section extension, and the joints take over the function of the lower leg plate. With the remote control, when the inverted patient orientation is selected, the right and left joints can be moved independently of each other. The default setting on the remote control is for the joints to be adjusted together. The joints cannot be adjusted individually if a single-part tabletop section is

19

Description attached to both joints. The single-part tabletop section is automatically recognized by the operating table and the functions of the individual joints are locked. 4.2.11

Level position The level position is a defined starting position in which the operating tabletop is moved to a horizontal position. The level position function combines the following functions: – Tilt function: The operating tabletop is adjusted horizontally around its longitudinal axis. – Trendelenburg function: The operating tabletop is adjusted horizontally around its transverse axis. – Longitudinal slide and transverse slide functions 2): The operating tabletop moves to its original position. The original position is dependent on the operating tabletop used. The mechanical longitudinal travel of the pediatric operating tabletop must be manually moved to the level position. If the extension adapter is attached to the operating tabletop, longitudinal travel is locked. – The motorized joints of the operating tabletop are set horizontally. 2 ) If the extension adapter is attached to the operating tabletop, the leg section joints are locked. – Lifting function: The operating table column without the operating tabletop is moved into the lower lift position (transfer position). The operating table column with the operating tabletop is moved into the upper lift position (transfer position). For a completely level position on the operating table, the mechanical hinges on the operating tabletop must be brought manually into the horizontal position.

4.2.12

Flex down / flex up

A

The operating tabletop folds electrically between the seat and back section. In the flex down position [A], both ends of the operating tabletop are moved downward (reverse Trendelenburg function and back section down). In the flex up position [B], both ends of the operating tabletop are moved upward (Trendelenburg function and back section up).

B

2 ) Dependent on the equipment of the operating tabletop

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