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SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)

Page 5 of 79

Chapter 1. General

1.1. About these instructions for use

These instructions for use provide the information necessary to operate the GEMS‐H device

. PLEASE READ THESE

INSTRUCTIONS FOR USE BEFORE OPERATING THE SYSTEM.

If any part of these instructions for use is not clear,

please contact Customer Support for assistance.

1.2. Explanation of symbols

Safety notes

Safety notes in these instructions for use are introduced with a symbol and a signal word to describe the severity of

the hazard.

Follow these safety notes and proceed with caution to avoid accidents, personal injury, damage to property, and to

ensure patient safety.

Safety notes

Meaning

This symbol and the word “WARNING” indicate a possible hazardous
situation that, if not avoided, could cause death or serious injury.

This symbol and the word “CAUTION” indicate a possible hazardous situation
that, if not avoided, could result in minor or moderate injury.

This symbol and the word “NOTICE” indicate a possible hazardous situation
that, if not avoid, could result in damage to property or the environment.

Hints, recommendations

Symbol

Meaning

This symbol emphasizes useful tips and recommendations as well as
information for the efficient and trouble‐free use of the product.

Содержание GEMS-H

Страница 1: ...GEMS H Instructions for Use ...

Страница 2: ...copyright All rights reserved Notably no portion of this publication may be reproduced or made available to third parties in any form online or offline without the written consent of Samsung Electronics Co Ltd Further no portion of this publication may be translated into a language or code that can be utilized for machines in particular data processing systems or the internet This document may exc...

Страница 3: ...6 Patient environment 13 Chapter4 Device description 14 4 1 Package contents 14 4 2 Device overview 16 4 3 Accessory waist extension belt 17 4 4 Accessory thigh support frame 17 4 5 Accessory thigh support strap 18 4 6 Marking plate 19 Chapter5 Preparation 20 5 1 Device fitting procedure 20 5 2 Determine the waist part size 21 5 3 Adjust the waist part width 23 5 4 Wear the waist belt fasten thigh...

Страница 4: ... 2 Turn off the device 59 7 3 How to take off the device 60 Chapter8 Maintenance 61 8 1 Storage 61 8 2 Regular maintenance Weekly Checklist 62 8 3 Cleaning 62 8 4 How to charge the GEMS H 63 Chapter9 Troubleshooting 65 9 1 Troubleshooting 65 9 2 Device messages 66 Chapter10 Technical specifications 70 10 1 Specifications 70 10 2 EMC Electromagnetic Compatibility 72 Chapter11 Clinical studies 77 11...

Страница 5: ...Follow these safety notes and proceed with caution to avoid accidents personal injury damage to property and to ensure patient safety Safety notes Meaning This symbol and the word WARNING indicate a possible hazardous situation that if not avoided could cause death or serious injury This symbol and the word CAUTION indicate a possible hazardous situation that if not avoided could result in minor o...

Страница 6: ...program prior to use of the device The device is not intended for sports 2 2 Training The GEMS H should be used only by medical personnel who have received specific training provided by Samsung Inc in the use of this device Training provided by Samsung is limited to the use of the GEMS H and does not replace the necessary medical training and experience required to perform rehabilitation 2 3 Safe ...

Страница 7: ...e Walk Assist mode which is operated based on the DOC Delayed Output Control algorithm In the DOC algorithm an on board microprocessor receives signals from integrated sensors which provide information on the patient s joint angles The sensors in the device detect the hip joint angle and associated angular velocity from the patient s gait based on which the central processor determines the optimal...

Страница 8: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 8 of 79 For further information with regard to the clinical studies refer to Chapter 11 Clinical studies ...

Страница 9: ...tructions for use Non ionizingelectromagneticradiation Degree of protection against particulate matter Caution Federal law restricts this device for sale by or on the order of a physician This mark is a Nationally Recognized Testing Lab NRTL marking and indicates conformance with UL 60601 1 Fragile Keep dry Temperaturelimit Atmosphericpressurelimitation Humiditylimitation ...

Страница 10: ...in injury to the patient Do not use in improper environments e g on the sand in stony areas or any surface that is not recommended by manufacturer Refer to section 2 3 Safe environments Risk of serious injury to the patient who is distracted or cannot pay attention to tasks If the patient is distracted or uses the device without caution it could result in loss of balance and possible injury The GE...

Страница 11: ... to the patient due to improper fitting or fitting too tightly Skin abrasions including discomfort skin pressure friction bruising pain or unusual swelling may result from the device being improperly fitted or fitted too tightly The device must be fitted over clothing to prevent skin abrasions When putting on the device the thigh support straps should be fitted with the knees slightly bent to avoi...

Страница 12: ...ing due to using discharged battery Use of the device with a low battery may result in the device may suddenly turning off during rehabilitation which stops the assistive force This may result in the patient having difficulty balancing and potentially falling To ensure continuous power during use always charge the battery at the end of each training session When the battery level is below 20 charg...

Страница 13: ...ins electrical and electronic equipment waste which must be disposed of separately from unsorted municipal waste Please contact the manufacturer or an authorized disposal company to decommission your equipment according to local regulations 3 6 Patient environment Part within the patient environment Device Tablet PC Part outside the patient environment Device charger Tablet PC charger The device c...

Страница 14: ...with buckles Sizes S M L Tablet PC Tablet PC case Device charger Tablet PC charger Hip width ruler Extension belt Torque wrench Storage case Instructions for use Depending on the wearer s size these components are used in combination For safe storage place the GEMS H in the case after each use Waist part Sizes S M L Thigh support frame Sizes S M left right Thigh support strap with buckles Sizes S ...

Страница 15: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 15 of 79 Device charger Tablet PC charger Hip width ruler Extension belt Torque wrench Storage case Tablet PC case optional Instructions for use ...

Страница 16: ...plier 3 Power switch Power ON OFF switch switch up ON switch down OFF 4 Waist belt Waist belt 5 Actuator module Motor and reduction gears for generating the assistive force 6 Thigh support frame Rigid frame delivering the assistive force to the wearer s thigh 7 Thigh support strap Fastening strap connecting the thigh support frame and to the wearer s thigh ...

Страница 17: ...on belt may be used to increase the length of the waist belt by 5 9 inches 150 mm It is used when the waist belt of the device is too short to fasten completely and comfortably around the patient s waist 4 4 Accessory thigh support frame Small size Medium size Length inches mm 9 1 230 10 0 255 ...

Страница 18: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 18 of 79 4 5 Accessory thigh support strap Small size Medium size Large size Length inches mm 14 2 360 16 1 410 17 7 450 ...

Страница 19: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 19 of 79 4 6 Marking plate ...

Страница 20: ...part width according to the wearer s hip width Details of the waist part adjustment are shown in section 5 3 Adjust the waist part width Use the extension belt if the length of the waist belt is too short The extension belt may be used to increase the length of the waist belt by up to 5 9 inches 150 mm Use a Medium size thigh support frame initially If the thigh support frame area comes in contact...

Страница 21: ...adjusted within a range of about 2 inches 50 mm by adjustment of the waist part Small inches mm Medium inches mm Large inches mm Hip width 12 4 14 4 315 365 14 0 15 9 355 405 15 9 17 9 405 455 Waist depth 5 7 6 7 145 170 7 9 9 8 200 250 9 4 12 2 240 310 Waist circumference 30 7 34 3 780 870 32 3 36 2 820 920 36 2 43 3 920 1100 ...

Страница 22: ...ach side by the hip width ruler provided as shown below and is usually suitable if the measurement is taken loosely If the device is still too tight the user should adjust the device for patient comfort at their discretion Identify the hip joint location Measure the hip width using the ruler provided as shown above Select the waist part size which fits the wearer s hip width hip width 12 4 14 4 31...

Страница 23: ...ench provided Do not tighten further after clicking sounds emit from the torque wrench provided Property damage when the screws are not fully tightened If the screws are not fully tightened the screws will be too loose during walking and the waist part may be damaged Before putting the device on the patient check that the screws are tightened securely enough that noise is not made as the screws lo...

Страница 24: ...Once the waist part has been adjusted to the appropriate size use the provided torque wrench to tighten turn clockwise the screws until the wrench clicks 5 4 Wear the waist belt fasten thigh support frames Risk of serious injury due to improper device sizing to the patient Improper sizing of the waist part and thigh support frames could cause skeletal fractures and injury to the patient The therap...

Страница 25: ... the therapist attaches the thigh support frames loosely the thigh support frames may be disconnected during walking This may result in the patient having difficulty balancing and potentially falling Make sure that the thigh support frame fastening hook is securely fastened before walking Check whether the release button had popped out and also try pulling out the thigh support frame Open the wais...

Страница 26: ... fitted with the knees slightly bent to avoid excessive tightening or pressing The therapist should check for discomfort and check the skin pressure of the patient Risk of falling due to broken buckle If you insert the buckle while pulling sideways the buckle may be broken This may result in the patient having difficulty balancing and potentially falling When inserting the buckle into the hook ins...

Страница 27: ...elect the Medium waist part the Small thigh support frames and the Large thigh support straps and so on Use a Medium size thigh support strap initially Switch to Small or Large size if needed Fasten both thigh support straps by attaching the buckles on the strap to the thigh support frame Make sure the strap Velcro is securely fastened around the wearer s leg Here is how to connect the strap with ...

Страница 28: ...ask the patient to walk in place to check for any discomfort If so reposition the device or try donning the device again The therapist may need to re adjust the waist part width or the tightness of the waist belt 1 Examples of correct and incorrect waist part positioning The rotation axis of the actuator should align with the greater trochanter The control pack should rest directly below the lumba...

Страница 29: ...ke the wearer walk around to check for any discomfort If there is discomfort reposition the device or try donning the device again You may need to readjust the width of the waist part or the waist belt tightness Confirm with the patient that there is no pinching of the skin If the patient is comfortable then the measurement is acceptable Check if the greater trochanter area is making contact with ...

Страница 30: ...trol LED are ON which indicates that the device is booting up This may take up to 15 seconds When device is ready for operation only the orange light is on Sequence of LED control LED and power LED Lighting Situation LED state Example 1 Power off Both light off Control LED 2 Power on Power light on Power LED 3 Power on booting up Green and orange light on Control LED 4 Device on and ready for oper...

Страница 31: ...ing the GEMS H application 6 2 1 Opening the GEMS H application An android application controls and monitors the GEMS H using Bluetooth communication Press the GEMS H icon on the home screen of the tablet PC to execute the application and it will show the login screen ...

Страница 32: ...s button at the bottom left of the home screen as shown below 2 Press the Close all button If the user does not close the application properly the following message will appear when the application is run again Please press the RESTART button to start the application anew or press the CONTINUE button to continue using the current application ...

Страница 33: ... use the app as a general user by using a password given by an administrator Administrators can change the user password with admin password in order to manage authorized users 6 3 2 Changing the user and admin password The initial admin password will be given by the manufacturer and the administrator can later change the password as needed If you forget the admin password you will need to contact...

Страница 34: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 34 of 79 Click Change password Enter the admin password Select user or admin and save the new password ...

Страница 35: ...to manage patient information See section 6 5 The Patient Info tab for details 2 Device Connect Tab User interface for connecting the device using Bluetooth See section 6 6 The Device Connect tab for details 3 Device Control Tab User interface to control the device See section 6 7 The Device Control tab for details ...

Страница 36: ...t the patient ID from the list and load the information accordingly Give a new patient ID for the first time patients and specify name gender age height weight and note associated with a patient ID Patient information is only for user reference and does not affect any functions of the device Therefore input of patient information can be skipped ...

Страница 37: ... the SAVE button to save the patient ID and associated patient information If you use a patient ID that already exists all previous information will be updated with the new information Press the DEL button to delete patient ID and associated information ...

Страница 38: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 38 of 79 Uncheck Unit US in order to use SI Units instead of US Units ...

Страница 39: ... on the top of the clasp Select the name of the device to enable so that it is highlighted in yellow Press the SCAN button again if the desired device is not found Connect the selected device by pressing the CONNECT button message will appear and the text on the button will changed to DISCONNECT ...

Страница 40: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 40 of 79 6 7 The Device Control tab The screen configuration of the Device Control tab is shown below ...

Страница 41: ...o open the Monitoring Option Screen In the monitoring option screen the user may select data to be displayed on the main screen graphically or textually These selections may be made by checking Graph or Text in the relevant row of the monitoring option screen The MAX column shows the graph range for each monitoring data The default settings of the monitoring option screen are shown below above ...

Страница 42: ... the possible monitoring data variables JointAngL left hip joint angle JointAngR right hip joint angle JointVelL left hip joint angular velocity JointVelR right hip joint angular velocity JointTrqL left hip assist torque measured JointTrqR right hip assist torque measured ImuEulerX Euler angle of X axis from the IMU sensor ImuEulerY Euler angle of Y axis from the IMU sensor ImuEulerZ Euler angle o...

Страница 43: ...acceleration of Z axis from the IMU sensor LeftButton currently not available RightButton currently not available ControlTrqL left hip torque goal from the algorithm ControlTrqR right hip torque goal from the algorithm Description of monitoring data 2 Monitoring Stop If you want to look at the graph in detail you can freeze the monitoring data by pressing the Monitoring Stop button and zoom in on ...

Страница 44: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 44 of 79 4 Text Screen Patient Info Patient ID and name Device Info Device ID time duration since power on and battery level Mode ...

Страница 45: ...both the left and right joint angle options are selected within the monitoring option dialog Reset the hip angle sensor while the patient is standing in a neutral posture with hips straight if possible or with comfortable posture otherwise This will be used as the reference position for calculating flexion and extension Press the Set Stand Pose button to reset the hip angle to zero and to calibrat...

Страница 46: ...ters are available as Normal and an additional saved parameter set called Strong is available by default Assist parameters can be saved with a user defined name using the Save button Parameters that are no longer needed can be deleted with the Del button The default parameters cannot be deleted Select the log check box to automatically log data when the assist starts If you are interested in using...

Страница 47: ...to run the assistance algorithm If the algorithm runs properly the tablet PC interface and the LEDs on the device will change as shown below 2 Stop assistance Press the STOP button to stop the assistance algorithm If the algorithm stops properly the tablet PC interface and LEDs on the device will change as shown below ...

Страница 48: ... Parameter control descriptions The parameter control area contains a number of parameters that can be controlled by the user while therapy is in progress The following illustrations and table describe the use of the parameter control area Assist pattern changes by controlling parameters ...

Страница 49: ...arameter ranges from 0 to 15 The default setting is 7 and usually assists around 5 Nm Guide Line Slow step time weak step pattern increase gain Heavy patient weight or small step length increase gain Light patient weight or too much assistive force decrease gain Delay Adjust timing to be early or late Each press will change the parameter by 0 1 This parameter ranges from 0 15 to 25 The default set...

Страница 50: ...gree flexion 100 degree which is used for safety functions Free Motion The device gives no assistive force and moves itself just enough to follow the patient as the patient moves Lock Buttons Disable all buttons to prevent accidental button presses Reset Params Reset all assist parameters back to initial values of the START point 6 7 3 2 Parameter control monitoring The therapist can monitor the c...

Страница 51: ...ameter Maximum Torque Parameters MaxTrqL MaxTrqR Users can monitor the maximum assistive torques that the device delivers to the patient as the user changes the assist gain The maximum assistive torques MaxTrqL and MaxTrqR indicate the maximum values of assistive torques provided by the device for the last two steps Even with parameters fixed the assistive strength will vary based on the patient w...

Страница 52: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 52 of 79 6 7 3 3 Example of parameter control ...

Страница 53: ...on Status of the device and recommended user action An alert will appear on the associated tablet PC if the battery level is below 20 and 10 and the battery level will be shown in red When the battery level is below 20 the physical therapist is recommended to charge the battery within 5 minutes When the battery level is below 10 it is recommended that device operation be stopped immediately and th...

Страница 54: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 54 of 79 Error message examples ...

Страница 55: ...ing the assistive force Status of the device and recommended user action If assistive force is ceased due to an over torque situation the associated tablet PC will display an error message of EXCEEDED TORQUE LIMIT When this message is displayed and the device is stopped the physical therapist may try to start the device again by pressing the START on the tablet PC If the problem persists reboot th...

Страница 56: ...yed output controller software is limited to a maximum of 100 degrees for flexion and a maximum of 40 degrees for extension in normal use Status of the device and recommended user action When the joint angle reaches the joint angle limit the device alerts the physical therapist by displaying a warning message of EXCEED JOINT LIMIT When the joint angle reaches these joint limits the device ceases a...

Страница 57: ...n Status of the device and recommended user action In the case that communication ceases the tablet PC alerts the physical therapist by displaying the DISCONNECTED warning message on the application For safety when such an event occurs the GEMS H continues at the current assistance setting The physical therapist should stop the current treatment and reconnect the tablet PC When the tablet PC is re...

Страница 58: ...ror DETECTED ABNORMAL ACTUATOR The actuator status is considered abnormal when data transmitted from the actuator does not match the expected signals for example when the device detects patient movement but actuator readings are constant This may result from disconnected communication lines actuator faults and or software failure The physical therapist should attempt to fix the problem by rebootin...

Страница 59: ...he assistance When the STOP button is touched on the tablet PC the device will cease applying assistive force and buttons in the Assist Control Area will deactivate 7 2 Turn off the device Turn off the power switch by pushing it down The green power LED indicator will turn off ...

Страница 60: ... on the thigh support frame to unhook the thigh support frame Detach both thigh support frames Unfasten the waist belt Velcro Open the waist belt and remove the device from the wearer s waist Be careful not to let the device fall Charge the device before its next use and place it in the storage case provided if use is not anticipated ...

Страница 61: ...nd the waist part are disconnected prior to storage The device should be stored under the following recommended environmental conditions Storage Transport Temperature 77 to 158 25 to 70 Humidity 10 to 94 non condensing Pressure 500 hPa to 1060 hPa When the device is not in use it is recommended that the device be stored in the shock resistant case as shown below ...

Страница 62: ...oper cleaning procedures or agents The product may be damaged if it is cleaned and disinfected with improper procedures or agents Use only this procedure for cleaning If the device is used by more than one patient it is essential to clean the device with disinfectant before use To prevent cross infection between patients the device i e waist part thigh support frames and thigh support straps shoul...

Страница 63: ...arger cable can be damaged beyond repair Make sure that the charge cable does not receive any force when the terminal pin is plugged in There is a terminal for charging on the right side of the control pack Charging begins automatically when the charger cable is plugged in When charging the LED lights on the charger are illuminated see image below After the device is fully charged the green charge...

Страница 64: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 64 of 79 ...

Страница 65: ...If you hear noise from the device that is not associated with normal use please contact the manufacturer No Bluetooth connection Make sure that Bluetooth is activated on the tablet PC Check this from Quick Settings on the top of the tablet screen Restart the GEMS H App Press the button left of the home button on the bottom of the tablet screen to completely close the app Restart the GEMS H Device ...

Страница 66: ...ted tablet PC The device turns off unexpectedly First turn off and then take off the device Restart the GEMS H Device Use the power switch located at the bottom of the control pack If the problem persists or occurs repeatedly please contact the manufacturer 9 2 Device messages Messages Causes Recommended action s Error DETECTED ABNORMAL ACTUATOR The physical therapist should attempt to fix the pro...

Страница 67: ...SAIT IFU GEMS H Rev 1 1 2019 11 Page 67 of 79 ...

Страница 68: ...the tablet PC If there is still a problem with the device turn off the device immediately and contact the manufacturer Warn EXCEEDED JOINT LIMIT When the joint angle reaches these joint limits the device ceases applying assistive force Thereafter the physical therapist may reset the device by asking the patient to stand with upright posture and tapping the Set Stand Pose button on the tablet PC Pr...

Страница 69: ...arn DISCONNECTED The physical therapist should stop the current treatment and reconnect the tablet PC When the tablet PC is reconnected to the GEMS H the application will display the message CONNECTED and the tablet PC resumes operation Status NORMAL OPERATION n a Status CONNECTED n a ...

Страница 70: ... range 2402 2480 MHz Bluetooth version V2 1 EDR Modulation type Frequency hopping spread spectrum Transmit power 4 61 dBm Peak Dwell time 0 4 s Product compliance The GEMS H is classified in the following categories for compliance with IEC 60601 1 Internally powered Type B applied part For continuous operation Not suitable for use in the presence of flammable anesthetics Not for use in the presenc...

Страница 71: ...ectronics Co Ltd Battery 7040 mAh CPU Octa Core 2 GHz 1 7 GHz Display Super AMOLED 2560 x 1600 10 5 inch 267 2 mm Network 2G GSM 3G UMTS 4G FDD LTE 4G TDD LTE Tablet PC Charger Model EP TA20JBE Manufacturer Samsung Electronics Co Ltd Input 100 240 Vac 50 60 Hz 0 5 A Output 9 0 Vdc 1 87 A or 5 0 Vdc 2 0 A Evaluated as a ME system in safety test For details of the tablet PC and its charger refer to ...

Страница 72: ...ons equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the GEMS H including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Risk of serious injury due to radiation If you are going to have an X ray CT scan MRI or be exposed to other types of radiation ...

Страница 73: ...test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 4 8 kV contact 2 4 8 15 kV air 8 kV contact 2 4 8 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity of at least 30 is recommended Electrical fast Transient burst IEC61000 4 4 2 kV for power supply lines 2 kV for power sup...

Страница 74: ...agnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Fiel...

Страница 75: ...output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refection from structures objects and people Guidance and manufacturer s declaration electromagnetic i...

Страница 76: ...15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a resi...

Страница 77: ...e primary objectives are 1 To determine safety and efficacy of Samsung GEMS H during physical therapy care in an outpatient setting for post stroke individuals 2 To determine the effect on gait speed as assessed by the 10 meter walk test after gait training using Samsung GEMS H device in an outpatient setting for post stroke individuals 11 2 Adverse events There was no serious device related adver...

Страница 78: ...ffect on functional balance as assessed by the Berg Balance Scale Functional Gait Assessment and Five Times Sit to Stand of task specific training with the Samsung GEMS device in an outpatient setting for post stroke individuals Endpoints The outcome measures will be assessed prior to the start of the training after 9 sessions after 18 sessions and a 1 month follow up testing visit which will be t...

Страница 79: ... 79 of 79 Statistical methods Multiple ANOVAs Summary conclusions Performance results Primary performance endpoints Secondary performance endpoints Safety results Primary safety endpoints Secondary safety endpoints Conclusions NCT number ...

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