Richmar HIVADOT User manual

DEEP OSCILLATION THERAPY DEVICE
INSTRUCTION MANUAL
3498.21.11.A

2
This manual is valid for the
HIVADOT® Deep Oscillation Therapy Device
This user manual is published by Richmar,
a division of Compass Health Brands.
Richmar, a division of Compass Health Brands, does not
guarantee its contents and reserves the right to improve
and amend it at any time without prior notice.
Amendments may however be published in new editions
of this manual.
All Right Reserved. Rev. A © 2022
Conformity to safety standards
Richmar declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, ISO10993-5,
ISO10993-10, ISO10993-1

3
TABLE OF CONTENTS
Legal Notice ____________________________________________ 4
Limited Warranty ________________________________________ 5
Foreword_______________________________________________ 7
Operator Qualifications ___________________________________ 7
Symbols _______________________________________________ 8
Precautionary Definitions __________________________________ 9
Warnings and Cautions____________________________________ 10
Product Descriptions _____________________________________ 14
Contraindications ________________________________________ 14
Technical Specifications ___________________________________ 15
Device Inspection ________________________________________ 16
Overview of Device and Accessories _________________________ 17
Operating Instructions ____________________________________ 21
1. Preparing Before Therapy _____________________________ 21
2. Start Treatment _____________________________________ 24
3. Treatment Start Up __________________________________ 25
Parameter Changes ______________________________________ 27
Treatment Screen Instructions _____________________________ 28
Care and Maintenance ____________________________________ 31
Routine Maintenance _____________________________________ 32
Battery Replacement _____________________________________ 33
Disposal________________________________________________ 34
Troubleshooting _________________________________________ 35
EMC Guidance __________________________________________ 36
Cable Information _______________________________________ 37
Assistance ______________________________________________ 43

4
LEGAL NOTICE
Distribution, reproduction and translation of the software and its
documentation (or excepts thereof) are prohibited without the prior
consent of Richmar, a division of Compass Health Brands.
Richmar, a division of Compass Health Brands reserves the right to
change the software and associated data without notice. All other
rights reserved.
For questions about your HIVADOT® Deep Oscillation Therapy
Device:
Richmar, a division of Compass Health Brands
6753 Engle Road
Middleburg Heights, OH 44130
Tech Support: 888-549-4945, Option 2
Email: [e-mail]

5
LIMITED WARRANTY
Congratulations on your purchase of the Richmar HIVADOT®.
Richmar, a division of Compass Health Brands, warrants that your
HIVADOT® is free of defects in material and workmanship. This
warranty shall remain in eect for three (3) years* from the date of
the original end user purchase. If this Product fails to function during
the warranty period due to a defect in materials or workmanship,
Richmar will repair or replace the respective Product without charge.
Richmar's sole obligation in the case of any breach of its warranty
set forth in the manual shall be, at Richmar's option, to replace the
Product with a new or factory certified refurbished product, without
charge to Richmar's purchaser or to refund the purchase price. It
is at the discretion of Richmar's purchaser, if they will refund their
customer and/or end user. If the Product is requested to be returned
and product plus accessories is unopened/unused it can be returned
minus a 25% restock fee, to the customer who purchased the Product
from Richmar. All product repairs must be performed by Richmar or
an authorized repair facility. Any modifications or repairs performed
by unauthorized centers or groups will void this warranty.
RICHMAR SHALL RESERVE THE RIGHT TO REQUEST PROOF OF
PURCHASE FROM THE END-USER TO VALIDATE THE WARRANTY
PERIOD
This warranty does not cover:
1. Replacement parts not provided by the manufacturer or labor
furnished by anyone other than a Richmar authorized repair
facility or technician.
2. Defects or damage caused by labor furnished by someone
other than Richmar or a certified service technician.
3. Any malfunction in the Product caused by product misuse,
including, but not limited to, the failure to provide reasonable
and required maintenance or any use that is inconsistent
with the Product’s Manual. RICHMAR SHALL NOT BE LIABLE
IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL
DAMAGES. Some locations DO NOT allow the exclusion or
limitation of incidental or consequential damages, so the above
limitation or exclusion may not apply to you.
*The device warranty only applies to the device and does not include
any accessories. All accessories have a 12 month warranty, except
the battery, which holds a 6 month warranty. Damages to the device
or accessories due to non-adherence with the Instruction Manual and
its warning and cautions will exclude the warranty.

6
To obtain replacement parts, service or a replacement device under
this warranty:
1. A claim must be made within the warranty period directly to
Richmar or the company from whom you purchased
the device.
2. An RMA number must be obtained from Richmar in order to
receive replacements parts and/or return defective product
under the warranty.
3. To contact Richmar's Tech Support Department for
troubleshooting and/or replacement request, please call: 888-
549.4549, Option 2.
This warranty gives you specific legal rights and you may also have
other rights which vary from location to location. Any representative
or agreement not contained in the warranty shall be void.
Information in this document is subject to change without prior
notice. The manufacturer of the equipment may have patents,
patent applications, trademarks, or copyrights covering material in
this document. This document does not grant license to any of these
intellectual property rights. The manufacturer shall not be liable for
any errors and/or omissions for incidental or consequential damages
in connection with the performance, or use of this material. All rights
reserved. Without limiting the rights under copyright law, no part
of this document may be reproduced, stored in or introduced into
a retrieval system, or transmitted in any way without the express
written permission of the manufacturer.

7
FOREWORD
This manual has been written for the owners and operators of the
HIVADOT®. It contains general information on the instructions for
safety, intended use, working principle, operation, maintenance,
trouble shooting, and warranty. In order to maximize the use,
eciency, and working life of your unit, please read this manual
thoroughly and become familiar with the controls, as well as the
accessories, before operating the unit.
OPERATOR QUALIFICATIONS
The HIVADOT® is intended for use by medical specialists and is
only allowed to be used by an end user if a qualified and instructed
medical clinician provides guidance and instructions. Specialists must
have the basic physical and cognitive prerequisites such as vision,
hearing, and literacy. Also, the basic function of the upper extremities
is expected.

8
Medical Device
Manufacturer
Medical Device
Correct Disposal of This Product (Waste Electrical & Electronic
Equipment) Statement: Contact the local authorities to determine
the proper method of disposal of potentially bio-hazardous parts
and accessories.
Medical Device
Type BF applied part complying with IEC 60601-1
This symbol indicates that this device is a Class II equipment accord-
ing to IEC 60601-1 (when charging)
Medical Device
Refer to instruction manual/ booklet
This symbol is the mark that identifies the ON/OFF button.
SYMBOLS
Symbols on the medical device
Medical Device
This side up
The transportation package must be vertical and straight up during
transportation.
Medical Device
Fragile, handle with care
The product inside the packaging could be easily damaged if
dropped or handled without care and attention.
Medical Device
Keep away from rain
The product package should keep out of the rain and not to store it
in damp conditions
Medical Device
Temperature limitation
The product package should be stored at a temperature between
-4° F and 131°F (-20°C and 55°C).
Medical Device
Upper limit of humidity
The product package should be stored at a humidity less than 93%.
Medical Device
Atmospheric pressure limitation
The product package should be stored at an atmospheric pressure
between 86kPa and 106kPa.
Symbols on the package
+55° C
93%
106kPa
86kPa
-20° C

9
PRECAUTIONARY DEFINITIONS
The precautionary instructions found in this section and throughout
this manual are indicated by specific symbols. Understand these
symbols and their definitions before operating this equipment.
The definition of these symbols is as follows:
Medical Device
CAUTION
Text with a “CAUTION” indicator will explain possible safety
infractions that could have the potential to cause minor to moderate
injury or damage to equipment.
Medical Device
WARNING
Text with a “WARNING” indicator will explain possible safety
infractions that will potentially cause serious injury and equipment
damage.
Medical Device
Refer to Instruction Manual/Booklet
NOTE: Throughout this manual, “NOTE” may be found. These Notes
are helpful information to aid in the particular area or function being
described.
Medical Device
Type BF applied part
The treatment head, adhesive electrodes and titanium neutral
element are considered as one type BF applied part.

10
WARNINGS AND CAUTIONS
Please read the user manual entirely before using the HIVADOT® and
take care of what follows:
Medical Device
WARNING
• Read, understand, and practice the precautionary operating
instructions. Know the limitations and hazards associated with
using the HIVADOT®. Observe the precautionary and operational
decals placed on the unit.
• Please reference the EMC Guidance at the end of the manual
regarding special precautions and electromagnetic environment
needed when using the device.
• Improper installation, operation, or maintenance of the HIVADOT®
may result in malfunctions of this unit or other devices.
• DO NOT use the device in the presence of a flammable anesthetic
mixture with air or oxygen, or nitrous oxide.
• In case of device failure or other obvious defects, switch the unit
o immediately, and notify a certified service technician.
• DO NOT use on persons with implanted demand type cardiac
pacemakers or defibrillators.
• DO NOT use on persons with severe heart failure or arrhythmia.
• DO NOT apply pulsed electrostatic fields over areas in which
symptoms of existing thrombosis or thrombophlebitis are present.
• DO NOT apply pulsed electrostatic fields over, or in proximity to,
cancerous lesions.
• DO NOT apply pulsed electrostatic fields over swollen, red, or
inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins).
• DO NOT apply pulsed electrostatic fields when the patient is in the
bath or shower.

11
• DO NOT apply pulsed electrostatic fields while the patient is
driving, operating machinery, or during any activity in which pulsed
electrostatic fields can put the patient at risk of injury.
• DO NOT use this device if you have a cardiac pacemaker,
implanted defibrillator, or other implanted metallic or electronic
device. Such use could cause electric shock, burns, electrical
interference, or death.
• DO NOT use this unit for purposes other than treatment indicated
in this manual.
• DO NOT use the HIVADOT® with high frequency surgical
equipment on the patient. It will cause unstable output when the
unit is close to the high frequency equipment (in the same room
and without shield).
• DO NOT use this device simultaneously with other therapeutic
device (such as microwave, shortwave), to avoid mis operation.
Operation in close proximity (e.g. 3 ft) to a shortwave or
microwave therapy device may produce instability in the device
output.
• Be sure to use only the specified battery (3.7 V, 2600 mAh, lithium
ion battery) provided by the manufacturer. Please contact your
distributor to purchase the batteries.
• Please stop using the battery when it appears abnormal, such as
bulging, cracked housing, or any shape changes.
• NEVER perform unauthorized service work. All service work
(except battery replacement) must be performed only by service
technicians who have been authorized by the manufacturer.
• Please dispose of the equipment and other accessories according
to local regulations. DO NOT treat them as household waste.
DO NOT put the device in fire or water. If the batteries are not
properly disposed, it may cause a battery explosion.

12
• If the unit is not functioning properly or you feel discomfort,
immediately stop using the unit. If you feel any discomfort
with your body or skin, consult the doctor and follow his/her
instructions.
• The adhesive electrodes and membranes are for single patient
use only, DO NOT use on another patient to prevent infection.
• If the adhesive electrodes loses viscosity, please replace the
electrode in order to maintain good electrical connection and to
avoid potential injury.
• DO NOT secure electrodes with none or little viscosity, using any
an other adhesive method such as, tape, bandaid, wraps, etc.
Electrodes MUST be replaced if not attached completely to the
treatment area, including lifting edges.
• Patients with suspected or diagnosed heart disease should
follow precautions recommended by their physicians before using
this device.
• Keep this device out of the reach of children.
• DO NOT use this device while sleeping. The main device may
malfunction or overheat, or the electrodes may move to an
unexpected region or potentially disconnect and cause harm to
the patient.
• DO NOT use this device if you have the following conditions:
1. Acute infections;
2. Acute inflammations with participation of pathogenic agents;
3. Active tuberculosis;
4. Acute venous diseases(untreated thromboses);
5. Untreated malignant processes;
6. Erysipelas;
7. Patients and therapists with cardiac pacemakers and other
electronic implants;
8. Untreated heart disorders and diseases, especially cardiac
insuciency, decompensated cardiac edema, and cardiac
arrhythmia;
9. Pregnancy;
10.Hypersensitivity to electrostatic fields;
11. Infectious skin diseases;
12.Vertebrobasilar insuciency (VBI).

13
Medical Device
CAUTION
• ALWAYS check the device and the accessories for damage
before use.
• Take care not to allow water to enter the device. Liquid penetration
could damage the device.
• DO NOT use volatile liquids, such as paint thinner or benzene,
because they may damage the plastic case.
• Ensure that the connectors are fully dry before connecting to
the device.
• Use this device only with the accessories recommended by the
manufacturer.
• Handle the device with care. DO NOT drop, knock, or shake the
device. Rough handling can damage internal circuit boards.
• DO NOT press, bend or damage the electric cable.
• ALWAYS unplug the power adapter from the device before
replacing the battery.
• Please charge the device at least every three months during long-
term storage.

14
PRODUCT DESCRIPTION
The HIVADOT® is a pulsed electric therapeutic electrostatic field
which is built up within the applicator and the patient’s tissue. Due to
the movement of the hand applicator or the therapists’ gloved hands,
a vibrating or pumping eect with deep impact is induced in the
patient’s tissue.
INDICATIONS FOR USE
The HIVADOT® is intended for:
1. Muscle relaxation
2. Increase circulation
3. Assists with lymphatic drainage
4. Temporary relief of minor aches and pains
5. Edema reduction
6. Improvement of wound healing
CONTRAINDICATIONS
Patients with the following disease diseases or conditions MUST NOT
use the HIVADOT®:
1. Acute infections;
2. Acute inflammations with participation of pathogenic agents;
3. Active tuberculosis;
4. Acute venous diseases(untreated thromboses);
5. Untreated malignant processes;
6. Erysipelas;
7. Patients and therapists with cardiac pacemakers and other
electronic implants;
8. Untreated heart disorders and diseases, especially
cardiac insuciency, decompensated cardiac edema, and
cardiac arrhythmia;
9. Pregnancy;
10. Hypersensitivity to electrostatic fields;
11. Infectious skin diseases;
12. Vertebrobasilar insuciency (VBI).

15
TECHNICAL SPECIFICATIONS
GENERAL
Product Name HIVADOT®
Product Model DO1009
Device Dimensions (W×L×H)
3.01"x 5.65"x 1.4"(76.5 x 143.5 x 35.5mm)
Device Weight 0.5 lbs
Interface 2.8" LCD screen
Software Release Version A
PERFORMANCE
Channel: Two
Output Waveform Symmetrical biphasic pulse
Output Voltage Adjustable, 0-900V (p-p), display
0-100%, stepping 10%.
Output Frequency Adjustable, 5-300 Hz, stepping 1 Hz
Modulation (on/o ratio) 1/4, 1/3, 1/2, 2/3, 3/4, 1/1, 2/1, 3/1, 4/1
Output Impedance 6 MΩ
Timer Max. 90 mins, divided into up to three
stages, each stage is 1-30 mins, default
20 mins, stepping 1 min.
ELECTRICAL
Power Supply of Adapter
Input AC100-240V, 50/60Hz; output DC 5V, 2A
Battery Specification 3.7V, 2600 mAh, lithium ion battery
Mode of Operation Continuous
System of Protection Class II, Type BF Applied Part
Ingress Protection IPX0
Rated Power 24 VA
OPERATION AND STORAGE CONDITION
Environmental Conditions of
Operation::
• Temperature: 41°F to 104°F (5°C to 40°C)
• Rel. humidity: ≤80%
• Atmosphere Pressure: 86 to 106kPa
Environmental Conditions of
Transport and Storage:
• Temperature: -4°F to 131°F (-20°C to 55°C)
• Rel. humidity: ≤93%
• Atmosphere Pressure: 86 to 106 kPa

16
DEVICE INSPECTION
Immediately upon unpacking the device, verify that all components are
not damaged and all contents are included:
1. Verify the delivery documents to make sure that the delivery is
complete.
2. Check the LCD screen when unpacking the product to make
sure it is in good condition. Any scratches on the surface after
use, will not be covered by the warranty.
3. Check the external components and accessories for possible
damage due to transport.
4. Verify that the packaging contains the following:
No. Description/Item # QTY UOM
1 The HIVADOT® device (DO1009) 1 each
2 HIVADOT®stand (DO1009STND) 1 each
3 Wall Adapter & USB Power Cord (DO1009X) 1 each
4Pin Lead Wires for Electrodes (White)
(DO1009PINLW) 2 pack
5Applicator/Titanium Element Lead Wires (Grey)
(DO1009APPLW) 2 pack
6 Applicator Handle (DO1009APP) 1 each
7 Titanium neutral element (DO1009ELEM) 1 each
8 5.5cm Oscillating Head (DO1099APP5) 1 each
9 10cm Oscillating Head (DO1009APP10) 1 each
10 MultiStim Electrodes
(400-8772) 4 pack
11 Box of Vinyl Gloves (VGPF3003) 100 box
12 Instruction Manual 1 each
13 Zipper Carrying Case (DO1009BAG) 1 each
HIVADOT®replacement accessories are available for purchase. Please
contact your distributor for more details.

17
OVERVIEW OF DEVICE AND ACCESSORIES
1. Output port 1*
2. Output port 2*
3. Type C power adapter port
4. Display screen
5. Power Button and Select
Button
6. UP button
7. DOWN button
8. START/PAUSE/SKIP
Phase button
9. Back/STOP button
*NOTE: Both output ports on the top of the device can
accommodate either the white or grey cord, interchangeably.

18
LEAD WIRES
Pin Connection Lead wires for Electrodes (White - 2.0mm plug) - 2/pk
Item #: DO1009PINLW
Applicator/Titanium Element Lead Wire (Grey - 4.0mm plug) - 2/pk
Item #: DO1009APPLW

19
OSCILLATING HEADS
1. Detachable oscillating heads
2. Applicator Handle
3. Applicator Connection
4. Applicator/Titanium Element Lead Wire Connector
ADHESIVE ELECTRODE
10cm Oscillating Head 5.5cm Oscillating Head
1.
2.
3.
4.

20
TITANIUM NEUTRAL ELEMENT
VINYL GLOVES (100/bx)
HIVADOT® STAND
NOTE: Use replacement parts only supplied by the manufacturer.
Contact your local dealer to place an order.