Anatomic SITT Zitzi Starfish Pro User manual

EN
ver. 2.2 - 2021-12-21
Zitzi
Starfish Pro
User manual
User manual, mounting and adjustment instructions,
service, maintenance and reconditioning

2User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]

3User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
This user manual refers to hygiene chair Zitzi Starfish Pro with
accessories. For a complete overview of the intended accessories,
see the product’s orderform.
Manufacturer.................................................4
Customization...............................................4
Introduction ..................................................5
General ......................................................................5
Correspondence - marking .............................5
CE-marking - classification..............................5
Declaration of conformity................................5
Inteded purpose...........................................5
Symbol list.....................................................6
Product labeling........................................... 7
Safety precautions ......................................8
Education and qualifications..........................8
Warnings and precautions...............................8
Control before use.............................................10
Restrictions ............................................................ 11
Remaining risks................................................... 12
Approved combinations ................................. 12
Divergency/Incidents ....................................... 12
Technical data/Performance................... 13
Adaptation and customization............... 14
Mounting and adjustment instructions. 15
Chassis.....................................................................16
Seat part................................................................20
Abduction/Adduction support.................... 21
Table of contents
Back............................................................................. 22
Hip angle ...................................................................23
Tilt of the seat unit ...............................................24
Hip support ..............................................................25
Armrest back...........................................................26
Armrest chassis...................................................... 27
Standard table........................................................28
Support table..........................................................28
Headrest ...................................................................29
Driving handle .......................................................29
Harnesses................................................................. 30
Hipbelt......................................................................... 31
Wheels......................................................................... 31
Footrest .....................................................................32
Calf support ............................................................34
Antitipper ................................................................35
Potty............................................................................36
Urine protection..................................................... 37
Summary and follow-up.............................. 38
Service and maintenance............................39
Control before use................................................39
Service and maintenance................................. 40
Reconditioning ........................................................41
Recycling ........................................................44
Warranty and complaint .............................45
Revision...........................................................46

4User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Check the check box if the
product is CUSTOMIZED.
The CE Mark is no longer valid
and should be removed.
This product is manufactured by Anatomic Sitt i Norrköping AB
Postal address Anatomic Sitt AB, Box 6137, SE-600 06 Norrköping
Street address Anatomic Sitt AB, Terminalgatan 1, SE-603 61 Norrköping
Phone [phone]
Email [e-mail]
Webb anatomicsitt.com
Instructions movies youtube.com/anatomicsitt
Follow us on facebook.com/anatomicsitt
Eudamed-registration number/SRN: SE-MF-000002240
Manufacturer
Customization

5User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Zitzi Starfish is a height-adjustable toilet and shower chair with wheels, intended
to enable personal hygiene for people with diculty using a standard toilet or
shower. The chair has several setting possibilities and can be equipped with various
accessories to achieve a specific sitting position.
Zitzi Starfish Pro is a reusable product.
Introduction
Inteded purpose
General
In order for you to make full use of the aid in a safe way, it is important that you
read this user manual properly. This concerns the caregivers and family who are
nursing the user. The user is the person sitting in the device and the caregiver is the
person operating the device.
Save the user guide/manual for future reference. New editions are available for
download from our website www.anatomicsitt.com. Information about the latest
revision can be found on the front page along with the date.
Correspondence - marking
The product label and its packaging contains the reference number (REF) and serial
number (SN - for main products) or batch number (LOT - for accessories). These
numbers shall be provided in correspondence with Anatomic Sitt. You find the serial
number on the front of the frame.
CE-marking - classification
he device with its accessories is a CE-marked medical device, Class I according to
the classification rules of Annex VIII (EU) 2017/745.
Declaration of conformity
The device complies with the requirements for medical devices under Regulation
(EU) 2017/745 on medical devices. See the current EU declaration of conformity for
product variants and accessories, see www.anatomicsitt.com/documents

6User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Symbol list
Set med 4 utskurna dekaler med svart tryck på vit botten. Svarta ytterlinjen ska vara kvar.
Om möjligt tvättålig 60-90°C. Antal: 250 st set
Set med 4 utskurna dekaler med svart tryck på vit botten. Svarta ytterlinjen ska vara kvar.
Om möjligt tvättålig 60-90°C. Antal: 250 st set
Set med 4 utskurna dekaler med svart tryck på vit botten. Svarta ytterlinjen ska vara kvar.
Om möjligt tvättålig 60-90°C. Antal: 250 st set
Sticker on drive handle.
Specifies control for backrest
angle
Sticker on drive handle.
Specifies control for tilt angle
Decal on the frame.
Specifies controls for locking the
backrest angle
Indicates that electronic products
should not be handled as general
waste.
This symbol is found in the user
manual and draws the reader’s
attention to e.g. important
safety information etc.
This symbol indicates any risk
of pinching.
The symbol indicates instructions
and tips which makes it easier
when using the product.
Indicates the manufacturing
batch number so that batch
can be identified.
Indicates that the operating
instruc-tions should always be read
before use. Web address indicates
where the document is located
electronically.
Indicates that the user manual
should be read to obtain important
safety information about e.g.
warnings not to be found on the
product label.
Indicates the manufacturer of the
medical device as defined in (EU)
MDR 2017/745.
Can also be used together with
the date of manufacture.
Indicates the date when the
medical device was
manufactured.
Unique product identifier such as
enables unambiguous identification of
specific medical devices.
Indicates that the product is a
medical device.
Indicates the manufacturer’s
reference number/article number
so that the medical device can be
identified.
Indicates the manufacturer’s
serial number so that a specific
technical product can be
identified.
Indicates that the product is CE
marked according to applicable
EU directives.
www.anatomicsitt.com

7User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Product labeling
Type of product
Product group
Product name
UDI-carrier
Max loadweight incl. user
Label for main product
Type of product
Product group/groups
Product name
UDI-carrier
Label for accessories

8User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Education and qualifications
• Mounting, service and reconditioning must always be done by qualified
personnel, (technicians at an aidcenter or equivalent).
• Decisions on adaptation/special adaptation must be made by qualified medical
personnel and performed by qualified professional personnel (technicians at an
aidcenter or equivalent).
• Settings, adjustments and testing of the aid must always be carried out by
qualified medical personnel (specialist personnel at an aidcenter or equivalent).
• The aids prescriber or person with equivalent competence and knowledge of
the user and the aid must always do a risk assessment before use.
Safety precautions
Warnings and precautions
Settings may only be done by qualified professionals. It is only permitted to
make settings in the manner described in this user manual.
Check the function of the product before handing it over to the user.
Adjustments may only be made in the way described in this instructions for use.
After all mounting and adjustment or service work is done, check and tighten
all fastening screws and nuts.
Prescriber or person with equivalent competence and knowledge of the user
to balance in the selected seat to ensure that any tipping risk is excluded.
The person who are prescribing the aid is responsible for instructing the user
and/or other persons in its immediate environment how to use the product
safely. Always check the function of the product before use.
Always read the user manual before use.

9User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Never use the footplate when getting in and out of the aid.
The brakes must always be locked when getting in and out.
Consider the risk of pinching when lowering/raising the seat or changing the
tilt. Have no hands under the seat during adjustments.
Be careful and be aware of the increased risk of tipping when using the chas-
sison sloping surfaces. The chassis should only be parked on horizontal and
level surfaces.
Always lift in the chassis - never in the seat.
Never do service while using the product.
Note that if the user grabs objects outside the aid or leans too far out of the
aid, a center of gravity shift can occur, which can lead to an increased risk of
tipping.
Never overload the device, see section Restrictions for the current maximum
load.
The castors can collide with the footplate in some cases. Note that the steering
ability therefor can be aected and settings may need to be changed.
Never leave the user unattended when using the aid.
Always check after use to detect redness or pressure marks on the patient.
Never lift the seating system with the user in the seat.

10User manual Zitzi Starfish Pro www.anatomicsitt.com | [phone]
Control before use
Inspection and control must be performed before each use according to below:
• Check the product and its accessories for loose parts, wear and injuries. In
particular, check screws and nuts as well as knobs.
• Check that the seat is securely attached to the chassis.
• Check the stability of the product.
• Check the function of any anti-tip devices.
• Check the function of the brakes.
• Check the condition of the wheels and that they are fastened.
• Check the product’s moving functions, such as back angle, tilt, height adjustment,
etc. regarding mobility and locking.
• Check the condition and adjustment of wires for tilt and back angle.
• Check belts and harnesses for wear, function and attachment.
If defects are noticed, do not use the product. Contact your distributor of the aid
for action.