CoolHealth TargetCool RM-DT02W User manual

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UV2-22

Thank you for your interest in TargetCool™ (Model: RM-DT02W). CoolHealth strives to provide our customers
with the highest quality devices, systems, and services
The TargetCool™ system includes a handheld device (hereinafter “the TargetCool™ device”) that – as part of a
system that includes guard, cartridge filter, and cartridge consumables (collectively “TargetCool™
consumables”) – can provide rapid, precise, and controlled cooling to the skin tissue. The TargetCool™
consumables are sold in a kit (hereinafter “the TargetCool™ Consumables Kit”), which is sold separately.
Information about how to purchase the TargetCool™ Kit and other TargetCool™ accessories can be found at
www.coolhealth.com.
This manual describes how to operate the TargetCool™ system with the main device and the TargetCool™
consumables. Please thoroughly familiarize yourself with this manual to make the most effective use of the
device and the consumables.
Observe all cautionary instructions, safety messages, and warnings that appear in this manual.
Due to continued technological improvements, this manual may not contain the most updated information and
is subject to change without prior notice. You can find the latest version of this manual at www.coolhealth.com.
This document is originally written in English.
For any issues not in this manual, please contact:
RecensMedical, Inc.
#507, #908, SK V1 center, 830Dongtansunhwan-daero,
Hwaseong-si, Gyeonggi-do, Republic of Korea
Tel: [phone]
Fax: [phone]
[e-mail]
CMC Medical Devices & Drugs S.L.
C/Horacio Lengo Nº18, CP 29006, Málaga, Spain
Tel: [phone]
Fax: [phone]
Document No.: UM-001-CV
Revision: Ver4.0, 2022-12
Copyright
All rights reserved. No parts of the content of this manual may be reproduced or distributed to the public, without
the prior written permission of CoolHealth. @ Copyright 2021, CoolHealth

Introduction
1.1 Inside the TargetCool™ Device Box 1
1.1.1 TargetCool™ Device and Grip 2
1.1.2 Nozzle 2
1.1.3 Charger (USB Type-C) and Power Cord 2
1.1.4 Cartridge Sleeve 2
1.1.5 Quick Reference Guide 2
1.2 Indications for Use 2
1.3 Who Can Use TargetCool™2
TargetCool™ Consumables (Sold Separately)
2.1 Inside the TargetCool™ Kit (Sold Separately) 3
2.1.1 Guard 4
2.1.2 Cartridge Filter 4
2.1.3 Cartridge 4
2.2 Who Can Use the Consumables in the TargetCool™ Consumables Kit 4
Safety and Regulations
3.1 Safety Signals and Color Labels 5
3.2 Symbols and Descriptions 6
3.3 Operator’s Qualifications 6
3.4 Operator’s Obligations 6
3.5 Contraindications 6
3.6 General Safety Management 6
3.7 Operational Safety Management 7

3.8 Electromagnetic Compatibility (EMC) 7
3.9 Standards and Regulations 7
3.9.1 Standards 7
3.9.2 Classifications (IEC 60601-1 6.1) 8
3.10 Labeling 8
3.10.1 TargetCool™ Device Label 8
3.10.2 TargetCool™ Device Packaging Label 8
3.10.3 TargetCool™ Consumables Kit Label (Sold Separately) 8
More About the TargetCool™ Device
4.1 TargetCool™ Device Components 9
4.1.1 Infrared (IR) Sensors 9
4.1.2 Guard Dock 9
4.1.3 Status Light 9
4.1.4 Trigger 10
4.1.5 LCD Display 10
4.1.6 Knob 10
4.1.7 Cartridge Cavity 10
4.1.8 Power LED Indicator 10
4.1.9 Charge Port 10
4.1.10 Power Switch 10
Using the TargetCool™ Device
5.1 Instructions on How to Install the Consumables
onto the TargetCool™ Device 11
Step 1: Select Nozzle and fully fasten it to the TargetCool™ 11
STEP 2-1: (Only for Cooling nozzle) Attach the guard onto the Guard Dock 11
Step 2-2: (Only for Boosting nozzle) Attach the Boosting container to the
Boosting guard 11
STEP 2-3: (Only for Freezing nozzle) Inspect the Guard Dock 11
Step 3: Insert the Cartridge Filter into the Cartridge Cavity 12
Step 4: Insert Cartridge Filter into the Cartridge Cavity 12
Step 5: Fasten a Cartridge into the Cartridge Cavity 12

5.2 Instructions on How to Operate the TargetCool™ Device (Cooling Mode) 13
Step 1: Turn On the TargetCool™ Device 13
Step 2: Inspect the LCD Display 13
Step 3: Aim the TargetCool™ Device at a Fixed Surface 13
Step 4: Press and Hold the Trigger Until You Hear Two Beeps 13
Step 5: Inspect the LCD Display 14
Step 6: Turn the Knob to Set Up the Target Temp. 14
Step 7: Press the Knob to Toggle to Time at Target Temp. 14
Step 8: Turn the Knob to Desired Time at Target Temp. 14
Step 9: Press and Hold the Knob Until You Hear Two Beeps 14
Step 10: Inspect the LCD Display 15
Step 11: Position Guard and Nozzle Over the Target Area 15
Step 12: Press and Trigger to Start the Spray 15
Step 13: Press the Trigger Once to Stop the Spray 16
OPTIOPNAL STEP: Reposition Guard and Nozzle Over Any Additional
To-Be Cooled Target Area 16
Step 14: Turn Off the TargetCool™ Device 16
5.3Instructions on How to Operate the TargetCool™ Device (Boosting Mode) 17
Step 1: Turn On the TargetCool™ Device 17
Step 2: Inspect the LCD Display 17
Step 3: Turn the Knob to Select Boosting Mode 17
Step 4: Press and Hold the Knob Until You Hear Two Beeps 17
Step 5: Inspect the LCD Display 17
Step 6: Press and Hold the Knob Until You Hear Two Beeps 17
Step 7: Position Guard and Nozzle Over the Target Area. 18
Step 8: Press and Trigger to Start the Spray 18
Step 9: Press the Trigger Once to Stop the Spray 18
Step 10: Turn Off the TargetCool™ Device 18
5.4Instructions on How to Operate the TargetCool™ Device (Freezing Mode) 19
Step 1: Turn On the TargetCool™ Device 19
Step 2: Inspect the LCD Display 19
Step 3: Turn the Knob to Select Freezing Mode 19
Step 4: Press and Hold the Knob Until You Hear Two Beeps 19

Step 5: Inspect the LCD Display 19
Step 6: Press and Hold the Knob Until You Hear Two Beeps 19
Step 7: Position Guard and Nozzle Over the Target Area. 19
Step 8: Press and Trigger to Start the Spray 20
Step 9: Turn Off the TargetCool™ Device 20
5.5 Instructions on How to Remove and Dispose of Used Consumables 20
Step 1: Ensure that the TargetCool™ Device Is Off 20
Step 2: A Cartridge Sleeve Over the Cartridge 20
Step 3: Point the Guard Up 20
Step 4: Slowly Turn the Cartridge Left for a Quarter Rotation 20
Step 5: Completely Unfasten and Discard the Cartridge 20
Step 6: Remove and Discard the Cartridge Filter 21
Step 7: Inspect the Cartridge Cavity to Ensure No Blockage 21
Step 8: Remove and Discard the Used Guard 21
General Maintenance
6.1 Cleaning (After Every Patient) 22
6.1.1 The TargetCool™ Device 22
6.1.2 The Nozzle 22
6.1.3 Guard Cleaning 22
6.2 Battery and Charging 22
6.3 Storage 22
6.3.1 The TargetCool™ Device 22
6.3.2 The TargetCool™ Consumables Kit 22
6.4 Repairs 23
Frequently Asked Questions
7.1 Frequently Asked Questions 24
Specifications
8.1 Operating & Storage Conditions 27
8.2 TargetCool™Device Specifications 27

Appendix A
9.1 Guidance and manufacturer’s declaration 28
9.1.1 Electromagnetic emissions 28
9.1.2 Electromagnetic immunity 28
9.1.3 Electromagnetic immunity –For non-life sustaining/supporting device 29
9.1.4 Recommended separation distances between portable and mobile RF
communications equipment and the device –For non-life sustaining/supporting
device 30
Product Warranty
1 Warranty Period 31
2 Exceptions from Warranty 31
3 Repair after Warranty Period 31

1
1.1 Inside the TargetCool™ Device Box
The TargetCool™ device box comes with the following:
TargetCool™device and Grip
Cooling nozzle
Boosting nozzle
Freezing nozzle
This chapter provides an overview of the contents of the TargetCool™ box, the indications for
use, and who can use the TargetCool™ system.
The contents of the TargetCool™ box are configured to be used with the TargetCoolTM
consumables in the TargetCool™Consumables Kit (sold separately). Information about how to
purchase the TargetCool™ Consumables Kit, along with other TargetCool™ accessories, can be
found at www.coolhealth.com.
Boosting Guard
User Manual
Quick Reference Guide
Charger (USB Type-C) and Power Cord
Cartridge Sleeve
Boosting nozzle
Sleeve
TargetCool device and Grip
Freezing nozzle
Cooling nozzle
Boosting guard

2
1.1.1 TargetCool™ device and Grip
The TargetCool™ grip is wrapped around the
TargetCool™ device, which is a handheld device
that –as part of a system that includes the
TargetCool™ Consumables kit –can provide rapid,
precise, and controlled cooling to the skin tissue.
1.1.2 Nozzle
The outlet of the nozzle is configured to spray
cryogen at a controlled, cool temperature to the
target area. TargetCool™ is compatible with three
nozzle types
- Cooling nozzle: Nozzle used in Cooling mode
- Freezing nozzle: Nozzle used in Freezing mode
- Boosting nozzle: Nozzle used in Boosting mode
1.1.3 Boosting Guard
The Boosting guard is used to connect the Boosting
container to the Boosting nozzle. The Boosting
guard can only be used when the device is set to
Boosting mode.
1.1.4 Charger (USB Type-C) and Power Cord
The charger (USB Type-C) charges the
TargetCool™ device when it is not in use.
Charger Specifications: Input: AC 100-240V-
50/60Hz 600mA
Output: DC 5V—3A, 9V—3A, 12V—2.5A, 15V—2A,
20V—1.5A
1.1.5 Cartridge Sleeve
The cartridge sleeve is configured to be wrapped
around the cartridge (sold separately).
1.1.6 Quick Reference Guide
The Quick Reference Guide offers an overview of
the TargetCool™ device and how to begin using it.
CoolHealth, Inc. assumes no liability for damage to
the device, injury to the user, or injury to the patient
that may occur when operating the TargetCool™
system without first completely reading the User
Guide, and fully adhering to the instructions and
warnings contained therein. If you have any
questions whatsoever about how to operate
TargetCool™ properly, please contact your sales
representative.
1.2 Intended Purpose
The TargetCool is for use when cryotherapy is
indicated for the temporary reduction of pain,
swelling, inflammation, and hematoma from surgical
procedures, sprains or other acute sports injuries,
and as an adjunct to rehabilitative treatment (e.g.
effects of analgesia, anesthesia and relaxation).
[Intended application]
- To decrease swelling/edema following trauma
(injury)
- To treat burns
- To treat Actinic keratosis
- To treat Naevus of Ota
- To treat warts
- To inhibit spasticity
- To reduce muscle spasm
- To reduce acute inflammatory reaction
- To reduce pain
- To reduce limb metabolism (also, it leads a
temporary anesthetic effect prior to surgical
process)
- To produce reactive hyperemia
- To facilitate muscular contraction for various forms
of neurogenic weakness and for muscle reeducation
- To treat restricted knee flexion due to traumatic
lower extremity fractures
1.3 Contraindications
- Hypertension (due to secondary vasoconstriction)
- Raynaud's disease
- Rheumatoid arthritis
- Local limb ischemia
- History of vascular impairment, such as frostbite or
arteriosclerosis
- Cold allergy (cold urticaria)
- Paroxysmal cold hemoglobinuria
- Cryoglobulinemia or any disease that produces a
marked cold pressor response

3
This chapter provides an overview of the TargetCool™ consumables, which can be found in the
TargetCool™ Consumables Kit.
The TargetCool™ consumables in the TargetCool™ Consumables Kit are configured to be used with
the contents of the TargetCool™ device box. The TargetCool™ Consumables Kit along with other
TargetCool™ accessories can be purchased at www.coolhealth.com.
2.1 Inside the TargetCool™ Consumables Kit
(Sold Separately)
The TargetCool™Consumables Kit comes with the following consumables.
Cartridge filter
Cooling Guard (Type-U)
Cooling Guard (Type-O, Optional)
Boosting Container
Cartridge
Cartridge filter
Cooling Guard (Type- U, Type-O)
Boosting Container
Cartridge