Summary of Contents for U-Sana medical Hall-U-Sana HA-500.404
- Page 1 Toe CPM Hall-U-Sana® Instructions for use English 0297 Version V5 November 9, 2023 HA-500.404 Hall-U-Sana User Manual_EN_V5 Instruction video Article No. HA-500.404...
- Page 3 Toe CPM Hall-U-Sana® Instructions for use English Request to the user and/or patient: any serious incident occurring in connec- tion with the device must be reported immediately to the manufacturer and the competent authority of the Member State in which the user and/or patient is located.
-
Page 4: Table Of Contents
Contents 1. Introduction .............................. 6 1.1 Intended use ...........................7 1.2 Indications ............................7 1.3 Contraindications ........................8 1.4 Side effects ............................. 8 1.5 General warning and caution .................... 8 1.6 Symbols ............................10 2. The toe CPM Hall-U-Sana® ......................11 2.1 The user interface of the control unit ...............12 3. - Page 5 Contents 7. Technical data ............................28 8. IEC 60601-1-2: 2014 ..........................29 8.1 Electromagnetic emissions ....................29 8.2 Electromagnetic immunity to interference ............30 8.3 Recommended protective distances .................32 9. Contact ..............................34 9.1 Legal manufacturer ........................34 9.2 For product queries and complaints .................34 9.3 For service, support and distribution ...............34 9.4 EC Authorized Representative ..................34 9.5 Warranty ............................34 Instructions for use Hall-U-Sana®...
-
Page 6: Introduction
1. Introduction The toe CPM Hall-U-Sana® supports rehabilitation in the post-operative phase after surgery of the 1st ray. These instructions for use are intended for patients and care personnel. All serious incidents related to the device must be reported to the manufac- turer and to the competent authority of the Member State in which the user and/or the patient is located. -
Page 7: Intended Use
1. Introduction 1.1 Intended use The intended use of the Hall-U-Sana® Continuous Passive Motion (CPM) de- vice is the support of post-operative treatment after surgery of the 1st ray through passive movement of the big toe. Passive movement of the toe during post-operative treatment reduces the risk of stiffness and remaining pain and prolonged postoperative swelling after surgery. -
Page 8: Contraindications
1. Introduction 1.3 Contraindications The toe CPM Hall-U-Sana® must not be used in the following cases: • Inflammatory skin changes that could be additionally irritated by the hol- ding apparatus (e.g., toe strap, foot strap) of the device (e.g., atopic eczema or ulcer) •... - Page 9 1. Introduction Warning • Treatment only if wound healing is advanced, at the earliest 2 weeks after surgery. • If the pain persists, consult your doctor. • No modifications may be made to this device. • The cable can be dangerous for children or pets. Keep the device out of the reach of children - risk of strangulation.
-
Page 10: Symbols
1. Introduction 1.6 Symbols The following symbols may appear on the product, on the packaging or in the instructions for use. Follow instructions for use Protection against access with a finger, protection against solid foreign bodies (diameter > 12.5 Warning: Observe the warnings mm), protection against falling in the instructions for use dripping water... -
Page 11: The Toe Cpm Hall-U-Sana
2. The toe CPM Hall-U-Sana® The illustrations below show the components of the toe CPM Hall-U-Sana®. Description Toe flap Foot strap with velcro fastener Toe glider Soft insole Toe strap with velcro fastener Slip-resistant sole (on the underside) Toe separator Control unit Instructions for use Hall-U-Sana®... -
Page 12: The User Interface Of The Control Unit
2. The toe CPM Hall-U-Sana® 2.1 The user interface of the control unit Description START PAUSE button: to switch on & off as well as to start and pause a programme Buttons for the direct selection of programme 1 or programme 2 Display showing the status and remaining treatment time in mi- nutes... -
Page 13: Adjusting The Toe Cpm Hall-U-Sana
3. Adjusting the toe CPM Hall-U-Sana® The toe CPM Hall-U-Sana® has been designed in such a way that only mini- mal adjustment is required, which can be carried out by the patient himself after a short period of self-study. 3.1 Use only in a sitting position Warning •... -
Page 14: Correct Placement Of The Foot On The Toe Cpm
3. Adjusting the toe CPM Hall-U-Sana® 3.2 Correct placement of the foot on the toe CPM During the treatment, the big toe should be gently moved up and down while attached to the movable toe flap. For this movement to be correct, it is important to position the foot so that the metatarsophalangeal joint of the big toe comes to rest in front of the toe flap's axis of rotation. -
Page 15: Fixation Of The Foot By Means Of The Foot Strap
3. Adjusting the toe CPM Hall-U-Sana® 3.3 Fixation of the foot by means of the foot strap The toe CPM Hall-U-Sana® can be used up to shoe size 45. Once the foot is pushed all the way forward against the toe separator, The next step is to tighten the foot strap by pulling the strap upwards until the foot is securely fastened to the sole. -
Page 16: Securing The Big Toe To The Toe Flap
3. Adjusting the toe CPM Hall-U-Sana® 3.4 Securing the big toe to the toe flap Caution • For effective treatment, pull the slider as far back as possible before tighten- ing the toe strap. The big toe must rest loosely in the open toe strap on the toe glider (slider). -
Page 17: Switch-On, Operation & Switch-Off
4. Switch-on, operation & switch-off 4.1 Switching on the toe CPM Hall-U-Sana® The toe CPM is switched on and later switched off again cen- trally via the control unit. To switch on, press and hold the START PAUSE button for 2 seconds. The device switches on. During start-up, the Hall-U-Sana®... -
Page 18: Two Predefined Programmes
4. Switch-on, operation & switch-off 4.2 Two predefined programmes The treatment is carried out by slowly moving the movable toe flap with the big toe secured to it (at 3 degrees per second) upwards (dorsal) and down- wards (plantar) by a motor: Starting position Upwards (dorsal) Downwards (plantar) -
Page 19: Selection Of The Desired Programme
4. Switch-on, operation & switch-off It is recommended to first use programme 1 for 4 to 5 days so that the meta- tarsophalangeal joint of the big toe has been prepared and an increased range of motion has been achieved: then you can switch to programme 2 (larger angle of +40°... -
Page 20: Starting The Selected Programme
4. Switch-on, operation & switch-off 4.4 Starting the selected programme Ensure that the patient is in a comfortable sitting position and that the toe CPM Hall-U-Sana® is lying flat on the floor. The control unit should be held in the hand during treatment or at least placed within reach so that it can be operated at any time (e.g. -
Page 21: Pausing The Programme
4. Switch-on, operation & switch-off 4.5 Interruption du programme Normally, once a programme has been started, it should be completed by the end of the 25-minute treatment period. However, it may happen that the programme must be interrupted if, for example: •... -
Page 22: Continuing Treatment
4. Switch-on, operation & switch-off 4.6 Continuing treatment Press the START PAUSE button again to continue the treatment. Accordingly, the LED ring and the writing turn green again. At the same time, the remaining treatment time is displayed. If the above problems persist or the pain continues, pause the treatment again and switch off the device (see Section 4.7). -
Page 23: Forced Switch-Off
4. Switch-on, operation & switch-off There are two ways to switch off: After 5 minutes of inactivity, the toe CPM switches off automatically. By keeping the START PAUSE button pressed for 2 seconds, the toe CPM can be switched off immediately. Before the device switches off, the "Power Off"... -
Page 24: Cleaning, Storage, Servicing & Environmental Information
5. Cleaning, storage, servicing & environmental information 5.1 Cleaning Warning • Do not clean under running water or with chemicals - the device is not waterproof (IP21). No liquid must get into the toe CPM or the control unit. • Do not use abrasive or corrosive cleaning agents. If necessary, the toe CPM and the control unit can be wiped clean with a damp, soft cloth. -
Page 25: Servicing & Returns
5.3 Servicing & returns Caution • Repairs and service work may only be carried out by a specialist authorised by U-Sana Medical AG. • Do not open the toe CPM or the control unit and do not remove the toe flap. -
Page 26: Troubleshooting
6. Troubleshooting The following problems can be remedied independently by the patient if necessary. If the problem persists, contact Lüdi Medical Rehab AG. Error / Action problem / error message Device does not Press and hold the START PAUSE button for 2 seconds. If the switch on device still does not switch on, contact Lüdi Medical Rehab Battery charge low... - Page 27 6. Troubleshooting Error / Action problem / error message The toe flap Press and hold the START PAUSE button for at least 2 se- remains in an conds to switch off the device > when the device is swit- oblique position ched on again, the toe flap automatically returns to the horizontal starting position.
-
Page 28: Technical Data
7. Technical data Weight: Toe CPM (incl. Li-ion battery) and control unit: 1.014 kg Dimensions (mm): • Toe CPM (shoe): 299 x 138 x 69 • Control unit: 115 x 47 x 18 Max. load on the 20 kg (even load distribution) toe CPM: Range of use: Shoe size 36 to 45, left and right foot... -
Page 29: Iec 60601-1-2: 2014
8. IEC 60601-1-2: 2014 8.1 Electromagnetic emissions The toe CPM Hall-U-Sana® is intended for operation in the electromagnetic environment described below. The user of the toe CPM Hall-U-Sana® should ensure that it is used in such an environment. Guidelines and manufacturer's declaration - Electromagnetic emissions Emission measure- Compliance Electromagnetic environment -... -
Page 30: Electromagnetic Immunity To Interference
8. IEC 60601-1-2: 2014 8.2 Electromagnetic immunity to interference The toe CPM Hall-U-Sana® is intended for operation in the electromagnetic environment described below. The user of the toe CPM Hall-U-Sana® should ensure that it is used in such an environment. Guidelines and manufacturer's declaration - Electromagnetic immunity to interference Immunity test... - Page 31 8. IEC 60601-1-2: 2014 Immunity test IEC 60601 test Compliance Electromagnetic level level environment - Guidelines Magnetic field at 3 A/m 3 A/m The magnetic fields with the supply fre- mains frequency have the quency (50/60 Hz) same characteristics as the according to magnetic fields in a hospital IEC 61000-4-8...
-
Page 32: Recommended Protective Distances
8. IEC 60601-1-2: 2014 8.3 Recommended protective distances The toe CPM Hall-U-Sana® is intended for operation in the electromagnetic environment specified below in which radiated RF disturbance parameters are controlled. The user of the toe CPM Hall-U-Sana® can help prevent electro- magnetic interference by maintaining minimum distances between portable and mobile RF communication devices (transmitters) and the toe CPM Hall- U-Sana®... - Page 33 8. IEC 60601-1-2: 2014 Note 1: An additional factor of 10/3 was used to calculate the recommended protective distance of transmitters in the frequency range from 80 MHz to 2.5 GHz to reduce the likelihood that a mobile/portable communication de- vice inadvertently introduced into the patient area would cause interference.
-
Page 34: Contact
9.1 Legal manufacturer Effectum Medical AG www.effectummedical.com Kirchgasse 11 E-mail: info@effectummedical.com 4600 Olten, Switzerland 9.2 For product queries and complaints U-Sana Medical AG www.usanamedical.com Hohlegasse 4 E-mail: info@usanamedical.com 4104 Oberwil, Switzerland 9.3 For service, support and distribution Lüdi Medical Rehab AG www.luedimedical.ch... - Page 36 www.usanamedical.com Legal Manufacturer: Effectum Medical AG, Kirchgasse 11, 4600 Olten, Switzerland, www.effectummedical.com...
Need help?
Do you have a question about the Hall-U-Sana HA-500.404 and is the answer not in the manual?
Questions and answers